Top

Published in:

Open Access 01-12-2022 | Study protocol

The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

Authors: Diana R. Pereira, Eunice R. Silva, Carina Carvalho-Maia, Sara Monteiro-Reis, Catarina Lourenço, Rita Calisto, Ricardo João Teixeira, Linda E. Carlson, Genevieve Bart, Seppo J. Vainio, M. Goreti F. Sales, Carmen Jerónimo, Rui Henrique

Published in: Trials | Issue 1/2022

Abstract

Background

Mindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects.

Methods

The current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group, and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week programme.

Discussion

This study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects.

Trial registration

ClinicalTrials.govNCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

Available only for authorised users

World Health Organization (WHO). Cancer. 2018. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed 7 Jan 2021.

World Health Organization (WHO). Global Cancer Observatory. 2021. https://gco.iarc.fr/. Accessed 7 Jan 2021.

Bergerot CD, Araujo TCCF. Assessment of distress and quality of life of cancer patients over the course of chemotherapy. Investig y Educ en Enfermería. 2014;32(2):216–24. https://doi.org/10.17533/udea.iee.v32n2a04.CrossRef

Harrington CB, Hansen JA, Moskowitz M, Todd BL, Feuerstein M. It’s not over when it’s over: long-term symptoms in cancer survivors-a systematic review. Int J Psychiatry Med. 2010;40(2):163–81. https://doi.org/10.2190/PM.40.2.c.CrossRefPubMed

Muzzatti B, Bomben F, Flaiban C, Piccinin M, Annunziata MA. Quality of life and psychological distress during cancer: a prospective observational study involving young breast cancer female patients. BMC Cancer. 2020;20(1):758. https://doi.org/10.1186/s12885-020-07272-8.CrossRefPubMedPubMedCentral

Ravindran OS, Shankar A, Murthy T. A comparative study on perceived stress, coping, quality of life, and hopelessness between cancer patients and survivors. Indian J Palliat Care. 2019;25(3):414–20. https://doi.org/10.4103/IJPC.IJPC_1_19.CrossRefPubMedPubMedCentral

National Comprehensive Cancer Network. NCCN guidelines for patients: distress during cancer care. 2020. https://www.nccn.org/patients/guidelines/content/PDF/distress-patient.pdf. Accessed 7 Jan 2021.

Riba MB, Donovan KA, Andersen B. Braun Ii, Breitbart WS, Brewer BW, et al. Distress management, version 3.2019. JNCCN J Natl Compr Cancer Netw. 2019;17(10):1229–49. https://doi.org/10.6004/jnccn.2019.0048.CrossRef

Ownby KK. Use of the Distress thermometer in clinical practice. J Adv Pract Oncol. 2019;10(2):175–9. https://doi.org/10.6004/jadpro.2019.10.2.7.CrossRefPubMedPubMedCentral

10.

Cillessen L, Johannsen M, Speckens AEM, Zachariae R. Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: a systematic review and meta-analysis of randomized controlled trials. Psychooncology. 2019;28(12):2257–69. https://doi.org/10.1002/pon.5214.CrossRefPubMedPubMedCentral

11.

Xunlin N, Lau Y, Klainin-Yobas P. The effectiveness of mindfulness-based interventions among cancer patients and survivors: a systematic review and meta-analysis. Support Care Cancer. 2020;28(4):1563–78. https://doi.org/10.1007/s00520-019-05219-9.CrossRefPubMed

12.

Kabat-Zinn J. Mindfulness. Mindfulness. 2015;6(6):1481–3. https://doi.org/10.1007/s12671-015-0456-x.CrossRef

13.

Baer RA. Mindfulness training as a clinical intervention: a conceptual and empirical review. Clin Psychol Sci Pract 2003;10(2):125–143. https://doi.org/10.1093/clipsy.bpg015

14.

Matis J, Svetlak M, Slezackova A, Svoboda M, Šumec R. Mindfulness-based programs for patients with cancer via eHealth and mobile health: systematic review and synthesis of quantitative research. J Med Internet Res. 2020;22(11):e20709. https://doi.org/10.2196/20709.CrossRefPubMedPubMedCentral

15.

Lau MA, Segal Z V. Mindfulness-based cognitive therapy as a relapse prevention: approach to depression. In: Witkiewitz K, Marlatt G, editors. Therapist’s guide to evidence-based relapse prevention. London: Academic Press; 2007. p. 73–90.

16.

Carlson LE, Tamagawa R, Stephen J, Drysdale E, Zhong L, Speca M. Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. Psychooncology. 2016;25(7):750–9. https://doi.org/10.1002/pon.4150.CrossRefPubMed

17.

Bower JE, Crosswell AD, Stanton AL, Crespi CM, Winston D, Arevalo J, et al. Mindfulness meditation for younger breast cancer survivors: a randomized controlled trial. Cancer. 2015;121(8):1231–40. https://doi.org/10.1002/cncr.29194.CrossRefPubMed

18.

Haller H, Winkler MM, Klose P, Dobos G, Kümmel S, Cramer H. Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. Acta Oncol. 2017;56(12):1665–76. https://doi.org/10.1080/0284186X.2017.1342862.CrossRefPubMed

19.

Howarth A, Smith JG, Perkins-Porras L, Ussher M. Effects of brief mindfulness-based interventions on health-related outcomes: a systematic review. Mindfulness. 2019;10(3):1957–68. https://doi.org/10.1007/s12671-019-01163-1.CrossRef

20.

Oberoi S, Yang J, Woodgate RL, Niraula S, Banerji S, Israels SJ, et al. Association of mindfulness-based interventions with anxiety severity in adults with cancer: a systematic review and meta-analysis. JAMA Netw Open. 2020;3(8):e2012598. https://doi.org/10.1001/jamanetworkopen.2020.12598.CrossRefPubMedPubMedCentral

21.

Kinner EM, Armer JS, McGregor BA, Duffecy J, Leighton S, Corden ME, et al. Internet-based group intervention for ovarian cancer survivors: feasibility and preliminary results. JMIR Cancer. 2018;4(1):e1. https://doi.org/10.2196/cancer.8430.CrossRefPubMedPubMedCentral

22.

Subnis UB, Farb NAS, Piedalue KAL, Speca M, Lupichuk S, Tang PA, et al. A smartphone app-based mindfulness intervention for cancer survivors: protocol for a randomized controlled trial. JMIR Res Protoc. 2020;9(5):e15178. https://doi.org/10.2196/15178.CrossRefPubMedPubMedCentral

23.

Zernicke KA, Campbell TS, Speca M, McCabe-Ruff K, Flowers S, Dirkse DA, et al. The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial. BMC Complement Altern Med. 2013;13(1):34. https://doi.org/10.1186/1472-6882-13-34.CrossRefPubMedPubMedCentral

24.

Tate KJ, Newbury-Birch D, McGeechan GJ. A systematic review of qualitative evidence of cancer patients’ attitudes to mindfulness. Eur J Cancer Care. 2018;27(2):e12783. https://doi.org/10.1111/ecc.12783.CrossRef

25.

Goliță S, Băban A. A systematic review of the effects of internet-based psychological interventions on emotional distress and quality of life in adult cancer patients. J Evidence-Based Psychother. 2019;19(2):47–78. https://doi.org/10.1016/j.jpsychores.2018.03.064.CrossRef

26.

Fu Z, Burger H, Arjadi R, Bockting CLH. Effectiveness of digital psychological interventions for mental health problems in low-income and middle-income countries: a systematic review and meta-analysis. The Lancet Psychiatry 2020;7(10):851–864. https://doi.org/10.1016/S2215-0366(20)30256-X

27.

Wang Y, Lin Y, Chen J, Wang C, Hu R, Wu Y. Effects of internet-based psycho-educational interventions on mental health and quality of life among cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2020;28(6):2541–52. https://doi.org/10.1007/s00520-020-05383-3.CrossRefPubMed

28.

Linardon J. Can acceptance, mindfulness, and self-compassion be learned by smartphone apps? A systematic and meta-analytic review of randomized controlled trials. Behav Ther. 2020;51(4):646–58. https://doi.org/10.1016/j.beth.2019.10.002.CrossRefPubMed

29.

Jongerius C, Russo S, Mazzocco K, Pravettoni G. Research-tested mobile apps for breast cancer care: systematic review. JMIR Mhealth Uhealth. 2019;21(2):e10930. https://doi.org/10.2196/10930.CrossRef

30.

Carlson LE, Subnis UB, Piedalue KAL, Vallerand J, Speca M, Lupichuk S, et al. The ONE-MIND Study: rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy. Eur J Cancer Care. 2019;28(4):e13074. https://doi.org/10.1111/ecc.13074.CrossRef

31.

Compen FR, Bisseling EM, Schellekens MPJ, Jansen ETM, Lee MLV, Speckens AEM. Mindfulness-based cognitive therapy for cancer patients delivered via internet: qualitative study of patient and therapist barriers and facilitators. J Med Internet Res. 2017;19(12):e407. https://doi.org/10.2196/jmir.7783.CrossRefPubMedPubMedCentral

32.

Wolvers MD, Bruggeman-Everts FZ, Van der Lee ML, Van de Schoot R, Vollenbroek-Hutten MM. Effectiveness, mediators, and effect predictors of internet interventions for chronic cancer-related fatigue: the design and an analysis plan of a 3-armed randomized controlled trial. JMIR Res Protoc. 2015;4(2):e77. https://doi.org/10.2196/resprot.4363.CrossRefPubMedPubMedCentral

33.

Kubo A, Kurtovich E, McGinnis MA, Aghaee S, Altschuler A, Quesenberry C, et al. Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers. Psychooncology. 2020. https://doi.org/10.1002/pon.5557.

34.

Toivonen K, Hermann M, White J, Speca M, Carlson LE. A mixed-method, multi-perspective investigation of barriers to participation in mindfulness-based cancer recovery. Mindfulness. 2020;11(10):2325–37. https://doi.org/10.1007/s12671-020-01461-z.CrossRef

35.

Torous J, Myrick KJ, Rauseo-Ricupero N, Firth J. Digital mental health and COVID-19: using technology today to accelerate the curve on access and quality tomorrow. J Med Internet Res. 2020;7(3):e18848. https://doi.org/10.2196/18848.CrossRef

36.

Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, et al. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet 2020;395(10241):1907–1918. https://doi.org/10.1016/S0140-6736(20)31187-9

37.

Schade EC, Elkaddoum R, Kourie HR. The psychological challenges for oncological patients in times of COVID-19 pandemic: telemedicine, a solution? Futur Oncol. 2020;16(29). https://doi.org/10.2217/fon-2020-0552

38.

Spijkerman MPJ, Pots WTM, Bohlmeijer ET. Effectiveness of online mindfulness-based interventions in improving mental health: a review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 2016;45:102–14. https://doi.org/10.1016/j.cpr.2016.03.009.CrossRefPubMed

39.

Zhang Y, Xue J, Huang Y. A meta-analysis: internet mindfulness-based interventions for stress management in the general population. Medicine. 2020;99(28):e20493. https://doi.org/10.1097/MD.0000000000020493.CrossRefPubMedPubMedCentral

40.

Bruggeman-Everts FZ, Wolvers MDJ, van de Schoot R, Vollenbroek-Hutten MMR, Van der Lee ML. Effectiveness of two web-based interventions for chronic cancer-related fatigue compared to an active control condition: results of the “fitter na kanker” randomized controlled trial. J Med Internet Res. 2017;19(10):e336. https://doi.org/10.2196/jmir.7180.CrossRefPubMedPubMedCentral

41.

Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, et al. Face-to-face and internet-based mindfulness-based cognitive therapy compared with treatment as usual in reducing psychological distress in patients with cancer: a multicenter randomized controlled trial. J Clin Oncol. 2018;36(23):2413–21. https://doi.org/10.1200/JCO.2017.76.5669.CrossRefPubMed

42.

Cillessen L, Schellekens MPJ, Van de Ven MOM, Donders ART, Compen FR, Bisseling EM, et al. Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Acta Oncol. 2018;57(10):1293–302. https://doi.org/10.1080/0284186X.2018.1479071.CrossRefPubMed

43.

Bruggeman Everts FZ, van der Lee ML, de Jager Meezenbroek E. Web-based individual mindfulness-based cognitive therapy for cancer-related fatigue - a pilot study. Internet Interv. 2015;2(2):200–13. https://doi.org/10.1016/j.invent.2015.03.004.CrossRef

44.

Kubo A, Altschuler A, Kurtovich S, Laurent CA, Kolevska T, Li Y, et al. A pilot mobile-based mindfulness intervetion for cancer patients and their informal caregivers. Mindfulness. 2018;9(6):1885–94. https://doi.org/10.1007/s12671-018-0931-2.CrossRefPubMedPubMedCentral

45.

Kubo A, Kurtovich E, McGinnis MA, Aghaee S, Altschuler A, Quesenberry C, et al. A randomized controlled trial of mHealth mindfulness intervention for cancer patients and informal cancer caregivers: a feasibility study within an integrated health care delivery system. Integr Cancer Ther. 2019;18:1534735419850634. https://doi.org/10.1177/1534735419850634.CrossRefPubMedPubMedCentral

46.

Messer D, Horan JJ, Larkey LK, Shanholtz CE. Effects of internet training in mindfulness meditation on variables related to cancer recovery. Mindfulness. 2019;10(3):2143–51. https://doi.org/10.1007/s12671-019-01182-y.CrossRef

47.

Price-Blackshear MA, Pratscher SD, Oyler DL, Armer JM, Cheng AL, Cheng MX, et al. Online couples mindfulness-based intervention for young breast cancer survivors and their partners: a randomized-control trial. J Psychosoc Oncol. 2020;38(5):592–611. https://doi.org/10.1080/07347332.2020.1778150.CrossRefPubMed

48.

Russell L, Ugalde A, Orellana L, Milne D, Krishnasamy M, Chambers R, et al. A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma. Support Care Cancer. 2019;27(7):2735–46. https://doi.org/10.1007/s00520-018-4574-6.CrossRefPubMed

49.

Zernicke KA, Campbell TS, Speca M, Mccabe-Ruff K, Flowers S, Carlson LE. A randomized wait-list controlled trial of feasibility and efficacy of an online mindfulness-based cancer recovery program: the eTherapy for cancer applying mindfulness trial. Psychosom Med. 2014;76(4):257–67. https://doi.org/10.1097/PSY.0000000000000053.CrossRefPubMed

50.

Zernicke KA, Campbell TS, Speca M, Ruff KMC, Flowers S, Tamagawa R, et al. The eCALM trial: eTherapy for cancer applying mindfulness. Exploratory analyses of the associations between online mindfulness-based cancer recovery participation and changes in mood, stress symptoms, mindfulness, posttraumatic growth, and spirituality. Mindfulness. 2016;7(5):1071–81. https://doi.org/10.1007/s12671-016-0545-5.CrossRef

51.

Mikolasek M, Witt CM, Barth J. Effects and implementation of a mindfulness and relaxation app for patients with cancer: mixed methods feasibility study. JMIR Cancer. 2021;7(1):e16785. https://doi.org/10.2196/16785.CrossRefPubMedPubMedCentral

52.

Nissen ER, O’Connor M, Kaldo V, Højris I, Borre M, Zachariae R, et al. Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: a randomized controlled trial. Psychooncology. 2020;29(1):68–75. https://doi.org/10.1002/pon.5237.CrossRefPubMed

53.

Milbury K, Weathers SP, Durrani S, Li Y, Whisenant M, Li J, et al. Online couple-based meditation intervention for patients with primary or metastatic brain tumors and their partners: results of a pilot randomized controlled trial. J Pain Symptom Manage. 2020;59(6):1260–7. https://doi.org/10.1016/j.jpainsymman.2020.02.004.CrossRefPubMed

54.

Compen F, Adang E, Bisseling E, van der Lee M, Speckens A. Cost-utility of individual internet-based and face-to-face mindfulness-based cognitive therapy compared with treatment as usual in reducing psychological distress in cancer patients. Psychooncology. 2020;29(2):294–303. https://doi.org/10.1002/pon.5246.CrossRefPubMed

55.

Reive C. The biological measurements of mindfulness-based stress reduction: a systematic review. Explore. 2019;15(4):295–307. https://doi.org/10.1016/j.explore.2019.01.001.CrossRefPubMed

56.

Rouleau CR, Garland SN, Carlson LE. The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Cancer Manag Res. 2015;7:121–31. https://doi.org/10.2147/CMAR.S64165.CrossRefPubMedPubMedCentral

57.

Sanada K, Alda Díez M, Salas Valero M, Pérez-Yus MC, Demarzo MMP, Montero-Marín J, et al. Effects of mindfulness-based interventions on biomarkers in healthy and cancer populations: a systematic review. BMC Complement Altern Med. 2017;17(1):125. https://doi.org/10.1186/s12906-017-1638-y.CrossRefPubMedPubMedCentral

58.

Pedro J, Monteiro-Reis S, Carvalho-Maia C, Henrique R, Jerónimo C, Silva ER. Evidence of psychological and biological effects of structured mindfulness-based interventions for cancer patients and survivors: a meta-review. Psychooncology. 2021;30(11):1836–48. https://doi.org/10.1002/pon.5771.CrossRefPubMed

59.

Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, et al. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003;65(4):564–70. https://doi.org/10.1097/01.psy.0000077505.67574.e3.CrossRefPubMed

60.

Lengacher CA, Reich RR, Kip KE, Barta M, Ramesar S, Paterson CL, et al. Influence of mindfulness-based stress reduction (MBSR) on telomerase activity in women with breast cancer (BC). Biol Res Nurs. 2014;16(4):438–47. https://doi.org/10.1177/1099800413519495.CrossRefPubMed

61.

Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, et al. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015;121(3):476–84. https://doi.org/10.1002/cncr.29063.CrossRefPubMed

62.

Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65(4):571–81. https://doi.org/10.1097/01.psy.0000074003.35911.41.CrossRefPubMed

63.

Witek Janusek L, Tell D, Mathews HL. Mindfulness based stress reduction provides psychological benefit and restores immune function of women newly diagnosed with breast cancer: a randomized trial with active control. Brain Behav Immun. 2019;80:358–73. https://doi.org/10.1016/j.bbi.2019.04.012.CrossRefPubMed

64.

Saxe GA, Hébert JR, Carmody JF, Kabat-Zinn J, Rosenzweig PH, Jarzobski D, et al. Can diet in conjunction with stress reduction affect the rate of increase in prostate specific antigen after biochemical recurrence of prostate cancer? J Urol 2001;166(6):2202–2207. https://doi.org/10.1016/S0022-5347(05)65535-8

65.

Cheng L, Doecke JD, Sharples RA, Villemagne VL, Fowler CJ, Rembach A, et al. Prognostic serum miRNA biomarkers associated with Alzheimer’s disease shows concordance with neuropsychological and neuroimaging assessment. Mol Psychiatry. 2015;20(10):1188–96. https://doi.org/10.1038/mp.2014.127.CrossRefPubMed

66.

Liu W, Bai X, Zhang A, Huang J, Xu S, Zhang J. Role of exosomes in central nervous system diseases. Front Mol Neurosci. 2019;12:240. https://doi.org/10.3389/fnmol.2019.00240.CrossRefPubMedPubMedCentral

67.

Saeedi S, Israel S, Nagy C, Turecki G. The emerging role of exosomes in mental disorders. Transl Psychiatry. 2019;9(1):122. https://doi.org/10.1038/s41398-019-0459-9.CrossRefPubMedPubMedCentral

68.

Simeone P, Bologna G, Lanuti P, Pierdomenico L, Guagnano MT, Pieragostino D, et al. Extracellular vesicles as signaling mediators and disease biomarkers across biological barriers. Int J Mol Sci. 2020;21(7):2514. https://doi.org/10.3390/ijms21072514.CrossRefPubMedCentral

69.

Whiteside TL. Tumor-derived exosomes and their role in cancer progression. Adv Clin Chem. 2016;74:103–41. https://doi.org/10.1016/bs.acc.2015.12.005.CrossRefPubMedPubMedCentral

70.

Becker A, Thakur BK, Weiss JM, Kim HS, Peinado H, Lyden D. Extracellular vesicles in cancer: cell-to-cell mediators of metastasis. Cancer Cell. 2016;30(6):836–48. https://doi.org/10.1016/j.ccell.2016.10.009.CrossRefPubMedPubMedCentral

71.

Xu R, Rai A, Chen M, Suwakulsiri W, Greening DW, Simpson RJ. Extracellular vesicles in cancer — implications for future improvements in cancer care. Nat Rev Clin Oncol. 2018;15(10):617–38. https://doi.org/10.1038/s41571-018-0036-9.CrossRefPubMed

72.

Bebelman MP, Smit MJ, Pegtel DM, Baglio SR. Biogenesis and function of extracellular vesicles in cancer. Pharmacol Ther. 2018;188:1–11. https://doi.org/10.1016/j.pharmthera.2018.02.013.CrossRefPubMed

73.

Hu T, Wolfram J, Srivastava S. Extracellular vesicles in cancer detection: hopes and hypes. Trends in Cancer. 2021;7(2):122–33. https://doi.org/10.1016/j.trecan.2020.09.003.CrossRefPubMed

74.

Hill AF. Extracellular vesicles and neurodegenerative diseases. J Neurosci. 2019;39(47):9269–73. https://doi.org/10.1523/JNEUROSCI.0147-18.2019.CrossRefPubMedPubMedCentral

75.

Ilgın C, Topuzoğlu A. Extracellular vesicles in psychiatry research in the context of RDoC criteria. Psychiatry Investig. 2018;15(11):1011–8. https://doi.org/10.30773/pi.2018.09.17.CrossRefPubMedPubMedCentral

76.

Monteiro-Reis S, Carvalho-Maia C, Bart G, Vainio SJ, Pedro J, Silva ER, et al. Secreted extracellular vesicle molecular cargo as a novel liquid biopsy diagnostics of central nervous system diseases. Int J Mol Sci. 2021;22(6):3267. https://doi.org/10.3390/ijms22063267.CrossRefPubMedPubMedCentral

77.

MindGAP project. https://mindgap-fet-open.eu. Accessed 7 Jan 2021.

78.

The Global Cancer Observatory. Portugal – source Globocan 2020. 2020. https://gco.iarc.fr/today/data/factsheets/populations/620-portugal-fact-sheets.pdf. Accessed 7 Jan 2021.

79.

Nissen ER, Zachariae R, O’Connor M, Kaldo V, Jørgensen CR, Højris I, et al. Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: predictors of treatment response. Internet Interv. 2021;23:100365. https://doi.org/10.1016/j.invent.2021.100365.CrossRefPubMedPubMedCentral

80.

Sun H, Thapa S, Wang B, Fu X, Yu S. A systematic review and meta-analysis of the distress thermometer for screening distress in Asian patients with cancer. J Clin Psychol Med Settings. 2021;28(2):212–20. https://doi.org/10.1007/s10880-020-09705-9.CrossRefPubMed

81.

Thapa S, Sun H, Pokhrel G, Wang B, Dahal S, Yu S. Performance of distress thermometer and associated factors of psychological distress among Chinese cancer patients. J Oncol. 2020;2020:3293589. https://doi.org/10.1155/2020/3293589.CrossRefPubMedPubMedCentral

82.

Faul F, Erdfelder E, Lang A, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. https://doi.org/10.3758/BF03193146.CrossRefPubMed

83.

Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.

84.

Bisseling E, Cillessen L, Spinhoven P, Schellekens M, Compen F, Van Der Lee M, et al. Development of the therapeutic alliance and its association with internet-based mindfulness-based cognitive therapy for distressed cancer patients: secondary analysis of a multicenter randomized controlled trial. J Med Internet Res. 2019;21(10):e14065. https://doi.org/10.2196/14065.CrossRefPubMedPubMedCentral

85.

Segal Z V., Williams M, Teasdale J. Mindfulness-based cognitive therapy for depression. 2nd ed. Guilford Publications; 2013.

86.

Kabat-Zinn J. Mindfulness-based stress reduction (MBSR). Authorized curriculum guide. 2017; https://mindfulness.nhsggc.org.uk/media/2105/mbsr-curriculum-guide-2017.pdf. .

87.

Carlson LE. Mindfulness-based interventions for physical conditions: a narrative review evaluating levels of evidence. ISRN Psychiatry. 2012;2012(5):651583. https://doi.org/10.5402/2012/651583.CrossRefPubMedPubMedCentral

88.

Compen FR, Bisseling EM, Van der Lee ML, Adang EMM, Donders ART, Speckens AEM. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based mindfulness-based cognitive therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study. BMC Psychol. 2015;3(1):27. https://doi.org/10.1186/s40359-015-0084-1.CrossRefPubMedPubMedCentral

89.

Bisseling EM, Schellekens MPJ, Spinhoven P, Compen FR, Speckens AEM, van der Lee ML. Therapeutic alliance—not therapist competence or group cohesion—contributes to reduction of psychological distress in group-based mindfulness-based cognitive therapy for cancer patients. Clin Psychol Psychother. 2019;26(3):309–18. https://doi.org/10.1002/cpp.2352.CrossRefPubMedPubMedCentral

90.

Williams JMG, Russell I, Russell D. Mindfulness-based cognitive therapy: further issues in current evidence and future research. J Consult Clin Psychol. 2008;76(3):524–9. https://doi.org/10.1037/0022-006X.76.3.524.CrossRefPubMedPubMedCentral

91.

UK Network of Mindfulness Teacher Training Organisations. Good practice guidance for teachers. 2015. https://bamba.org.uk/wp-content/uploads/2019/06/UK-MB-teacher-GPG-2015-final-2.pdf. Accessed 7 Jan 2021.

92.

Parsons CE, Crane C, Parsons LJ, Fjorback LO, Kuyken W. Home practice in mindfulness-based cognitive therapy and mindfulness-based stress reduction: a systematic review and meta-analysis of participants’ mindfulness practice and its association with outcomes. Behav Res Ther. 2017;95:29–41. https://doi.org/10.1016/j.brat.2017.05.004.CrossRefPubMedPubMedCentral

93.

Baydoun M, Moran C, McLennan A, Piedalue KAL, Oberoi D, Carlson LE. Mindfulness-based interventions in cancer survivors: a systematic review of participants’ adherence to home practice. Patient Prefer Adherence. 2021;15:1225–42. https://doi.org/10.2147/PPA.S267064.CrossRefPubMedPubMedCentral

94.

Mikolasek M, Witt CM, Barth J. Adherence to a mindfulness and relaxation self-care app for cancer patients: mixed-methods feasibility study. JMIR Mhealth Uhealth. 2018;6(12):e11271. https://doi.org/10.2196/11271.CrossRefPubMedPubMedCentral

95.

Wells C, Malins S, Clarke S, Skorodzien I, Biswas S, Sweeney T, et al. Using smart-messaging to enhance mindfulness-based cognitive therapy for cancer patients: a mixed methods proof of concept evaluation. Psychooncology. 2020;29(1):212–9. https://doi.org/10.1002/pon.5256.CrossRefPubMed

96.

Maas A, Schellekens MPJ, van Woezik RAM, van der Lee ML. Therapist behaviours in a web-based mindfulness-based cognitive therapy (eMBCT) for chronic cancer-related fatigue – analyses of e-mail correspondence. Internet Interv. 2020;22:100355. https://doi.org/10.1016/j.invent.2020.100355.CrossRefPubMedPubMedCentral

97.

Glynn BA, Khoo EL, MacLeay HML, Duong A, Cantave R, Poulin PA. Exploring cancer patients’ experiences of an online mindfulness-based program: a qualitative investigation. Mindfulness. 2020;11(7):1666–77. https://doi.org/10.1007/s12671-020-01380-z.CrossRefPubMedPubMedCentral

98.

Elliot R, Slatick E, Urman M. Qualitative process research on psychotherapy: alternative strategies. In: Frommer J, Rennie DL, editors. Qualitative psychotherapy research: methods and methodology. Lengerisch: Pabst Science Publishers; 2001. p. 69–111.

99.

Sales CMD, Gonçalves S, Silva IF, Duarte J, Sousa D, Fernandes E, et al. Portuguese adaptation of qualitative change process instruments. Paper presented at the European Meeting of the Society for Psychotherapy Research; 2007 Mar; Funchal, Portugal.

100.

Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. 2nd ed. Psychology Foundation: Sydney; 1995.

101.

Pais-Ribeiro JL, Honrado A, Leal I. Contribuição para o estudo de adaptação portuguesa das escalas de ansiedade, depressão e stress (EADS) de 21 itens de Lovibond e Lovibond. Psicol Saúde Doenças. 2004;5(2):229–39.

102.

Carey M, Bryant J, Zucca A, Hall A, Grady A, Dilworth S, et al. How well do cancer survivor self-classifications of anxiety, depression and stress agree with a standardised tool? Results of a cross-sectional study. PLoS One. 2019;14(9):e0222107. https://doi.org/10.1371/journal.pone.0222107.CrossRefPubMedPubMedCentral

103.

Fox RS, Lillis TA, Gerhart J, Hoerger M, Duberstein P. Multiple group confirmatory factor analysis of the DASS-21 Depression and Anxiety Scales: how do they perform in a cancer sample? Psychol Rep. 2018;121(3):548–65. https://doi.org/10.1177/0033294117727747.CrossRefPubMed

104.

Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy - a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011;124(2):102–19. https://doi.org/10.1111/j.1600-0447.2011.01704.x.CrossRefPubMed

105.

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-Being. J Pers Soc Psychol. 2003;85(2):348–62. https://doi.org/10.1037/0022-3514.85.2.348.CrossRefPubMed

106.

Vaz FM. Diferenciação e regulação emocional na idade adulta: tradução e validação de dois instrumentos de avaliação para a população portuguesa [master's thesis on the Internet]. Braga, Portugal: Faculdade de Psicologia da Universidade do Minho; 2009. http://repositorium.sdum.uminho.pt/bitstream/1822/9898/1/tese.pdf

107.

Preece DA, Becerra R, Robinson K, Gross JJ. The emotion regulation questionnaire: psychometric properties in general community samples. J Pers Assess. 2020;102(3):348–56. https://doi.org/10.1080/00223891.2018.1564319.CrossRefPubMed

108.

Brandão T, Schulz MS, Gross JJ, Matos PM. The emotion regulation questionnaire in women with cancer: a psychometric evaluation and an item response theory analysis. Psychooncology. 2017;26(10):1647–53. https://doi.org/10.1002/pon.4356.CrossRefPubMed

109.

Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018;16(1):30. https://doi.org/10.1186/s12955-018-0850-x.CrossRefPubMedPubMedCentral

110.

Yang Y, Humphris G, Sun H, Li W, Hao Y, Liu T, et al. Psychometric properties of the Chinese version fear of cancer recurrence questionnaire-7 (FCR-7). Prof Psychol Res Pract. 2019;50(6):376–83. https://doi.org/10.1037/pro0000257.CrossRef

111.

Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27–45. https://doi.org/10.1177/1073191105283504.CrossRefPubMed

112.

Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, et al. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008;15(3):329–42. https://doi.org/10.1177/1073191107313003.CrossRefPubMed

113.

Gregório S, Gouveia JP. Facetas de mindfulness: características psicométricas de um instrumento de avaliação. Psychologica. 2011;54(54):259–79. https://doi.org/10.14195/1647-8606_54_10.CrossRef

114.

Karl JA, Prado SMM, Gračanin A, Verhaeghen P, Ramos A, Mandal SP, et al. The cross-cultural validity of the five-facet mindfulness questionnaire across 16 countries. Mindfulness. 2020;11(5):1226–37. https://doi.org/10.1007/s12671-020-01333-6.CrossRef

115.

Heatherton TF, Kozlowski LT, Frecker RC, Fagerström K-O. The Fagerström test for nicotine dependence: a revision of the Fagerström tolerance questionnaire. Br J Addict. 1991;86(9):1119–27. https://doi.org/10.1111/j.1360-0443.1991.tb01879.x.CrossRefPubMed

116.

Ferreira PL, Quintal C, Lopes I, Taveira N. Teste de dependência à nicotina: validação linguística e psicométrica do teste de Fagerström. Rev Port Saúde Pública. 2009;27(2):37–56.

117.

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95. https://doi.org/10.1249/01.MSS.0000078924.61453.FB.CrossRefPubMed

118.

Campaniço HMPG. Validade simultânea do questionário internacional de actividade física através da medição objectiva da actividade física por actigrafia proporcional [master's thesis on the Internet]. Lisboa, Portugal: Faculdade de Motricidade Humana da Universidade de Lisboa; 2016. https://www.repository.utl.pt/bitstream/10400.5/11866/1/DISSERTA%c3%87%c3%83O%202016%20Helena%20Campani%c3%a7o.pdf

119.

Tedeschi RG, Calhoun LG. The posttraumatic growth inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996;9(3):455–71. https://doi.org/10.1007/BF02103658.CrossRefPubMed

120.

Silva SIM, Moreira HTC, Pinto SMA, Sousa MCC, Canavarro P. Cancro da mama e desenvolvimento pessoal e relational: estudo das características psicométricas do inventário de desenvolvimento pós-traumático (posttraumatic growth inventory) numa amostra de mulheres da população Portuguesa. Rev Iberoam Diagnostico y Eval Psicol. 2009;28(2):105–33.

121.

Ramos C, Leal I, Marôco AL, Tedeschi RG. The posttraumatic growth inventory: factor structure and invariance in a sample of breast cancer patients and in a non-clinical sample. Span J Psychol. 2016;19:E64. https://doi.org/10.1017/sjp.2016.65.CrossRefPubMed

122.

The WHOQOL Group. Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med. 1998;28(3):551–8. https://doi.org/10.1017/s0033291798006667.CrossRef

123.

Skevington SM, Lofty M, O’Connell KA. The World Health Organization’s WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004;13(2):299–310. https://doi.org/10.1023/B:QURE.0000018486.91360.00.CrossRefPubMed

124.

Serra AV, Canavarro MC, Simões MR, Pereira M, Gameiro S, Quartilho MJ, et al. Estudos psicométricos do instrumento de avaliação da qualidade de vida da Organização Mundial de Saúde (WHOQOL-Bref) para português de Portugal. Psiquiatr Clínica. 2006;27(1):41–9.

125.

Moreira H, Silva S, Canavarro C. Qualidade de vida e ajustamento psicossocial da mulher com cancro da mama: do diagnóstico à sobrevivência. Psicol Saúde Doenças. 2008;9(1):165–84.

126.

Silva S, Bettencourt D, Moreira H, Canavarro MC. Qualidade de vida de mulheres com cancro da mama nas diversas fases da doença: o papel de variáveis sociodemográficas, clínicas e das estratégias de coping enquanto factores de risco/protecão. Rev Port Saúde Publica. 2011;29(1):64–76. https://doi.org/10.1016/S0870-9025(11)70009-8.CrossRef

127.

Gomes AA, Marques DR, Meia-Via AM, Meia-Via M, Tavares J, Silva CF, et al. Basic Scale on Insomnia complaints and Quality of Sleep (BaSIQS): reliability, initial validity and normative scores in higher education students. Chronobiol Int. 2015;32(3):428–40. https://doi.org/10.3109/07420528.2014.986681.CrossRef

128.

Miller-Mendes M, Gomes AA, Marques DR, Clemente V, Azevedo MHP. BaSIQS - basic scale on insomnia complaints and quality of sleep: reliability, norms, validity, and accuracy studies, based on clinical and community samples. Chronobiol Int. 2019;36(5):644–56. https://doi.org/10.1080/07420528.2019.1578970.CrossRefPubMed

129.

Pais-Ribeiro J. Escala de Satisfação com o Suporte Social (ESSS). Análise Psicológica. 1999;17(3):547–58.

130.

Marôco JP, Campos JADB, Vinagre MDG, Pais-Ribeiro JL. Adaptação transcultural Brasil-Portugal da escala de satisfação com o suporte social para estudantes do ensino superior. Psicol Reflex e Crit. 2014;27(2):247–56. https://doi.org/10.1590/1678-7153.201427205.CrossRef

131.

Barkham M, Leach C, Lucock M, Evans C, Margison F, Mellor-Clark J, et al. Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. J Consult Clin Psychol. 2001;69(2):184–96. https://doi.org/10.1037//0022-006x.69.2.184.CrossRefPubMed

132.

Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002;180(1):51–60. https://doi.org/10.1192/bjp.180.1.51.CrossRefPubMed

133.

Evans C, Mellor-Clark J, Margison F, Barkham M, Audin K, Connell J, et al. CORE: Clinical Outcomes in Routine Evaluation. J Ment Heal. 2000;9(3):247–55. https://doi.org/10.1080/jmh.9.3.247.255.CrossRef

134.

Sales C, Moleiro CDM. Versão Portuguesa do CORE-OM: tradução, adaptação e estudo preliminar das suas propriedades psicométricas. Rev Psiquiatr Clin. 2012;39(2):54–9. https://doi.org/10.1590/S0101-60832012000200003.CrossRef

135.

Cumming G. Understanding the new statistics: effect sizes, confidence intervals, and meta-analysis. New York, USA: Routledge; 2012. https://doi.org/10.4324/9780203807002.CrossRef

136.

Bates D, Mächler M, Bolker BM, Walker SC. Fitting linear mixed-effects models using lme4. J Stat Softw. 2015;67(1):1–48. https://doi.org/10.18637/jss.v067.i01.CrossRef

137.

Kuznetsova A, Brockhoff PB, Christensen RHB. lmerTest Package: tests in linear mixed effects models. J Stat Softw. 2017;82(13):1–26. https://doi.org/10.18637/jss.v082.i13.CrossRef

138.

Core R. Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical. Computing. 2017; https://www.R-project.org/.

139.

Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. https://doi.org/10.1191/1478088706qp063oa.CrossRef

140.

Kiger ME, Varpio L. Thematic analysis of qualitative data: AMEE guide no. 131. Med Teach. 2020;42(8):846–54. https://doi.org/10.1080/0142159X.2020.1755030.CrossRefPubMed

141.

Clarke V, Braun V. Thematic analysis. In: Teo T, editor. Encyclopedia of critical psychology. New York: Springer US; 2014. p. 1947–52.CrossRef

142.

Castleberry A, Nolen A. Thematic analysis of qualitative research data: is it as easy as it sounds? Curr Pharm Teach Learn. 2018;10(6):807–15. https://doi.org/10.1016/j.cptl.2018.03.019.CrossRefPubMed

143.

Andersson G, Titov N. Advantages and limitations of Internet-based interventions for common mental disorders. World Psychiatry. 2014;13(1):4–11. https://doi.org/10.1002/wps.20083.CrossRefPubMedPubMedCentral

144.

Lapa T, Vieira J. Divisões digitais em Portugal e na Europa. Portugal ainda à procura do comboio europeu? Sociol Line. 2019;21(21):62–82. https://doi.org/10.30553/sociologiaonline.2019.21.3.CrossRef

145.

Mendes-Santos C, Andersson G, Weiderpass E, Santana R. Mitigating COVID-19 Impact on the Portuguese population mental health: the opportunity that lies in digital mental health. Front Public Heal. 2020;8:553345. https://doi.org/10.3389/fpubh.2020.553345.CrossRef

146.

Holm LV, Hansen DG, Johansen C, Vedsted P, Larsen PV, Kragstrup J, et al. Participation in cancer rehabilitation and unmet needs: a population-based cohort study. Support Care Cancer. 2012;20(11):2913–24. https://doi.org/10.1007/s00520-012-1420-0.CrossRefPubMedPubMedCentral

Title: The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study
Authors: Diana R. Pereira
Eunice R. Silva
Carina Carvalho-Maia
Sara Monteiro-Reis
Catarina Lourenço
Rita Calisto
Ricardo João Teixeira
Linda E. Carlson
Genevieve Bart
Seppo J. Vainio
M. Goreti F. Sales
Carmen Jerónimo
Rui Henrique
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06045-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Analgesic effect of auricular point acupressure for acute pain in patients with dementia: study protocol for a randomized controlled trial

The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial

The effect of probiotic cheese consumption on inflammatory and anti-inflammatory markers, disease severity, and symptoms in patients with rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled trial

Study protocol of brief intervention using gene polymorphism information for excessive drinking among Japanese college students and adults aged 20–30 years: a randomized controlled trial

Electro-acupuncture for protracted amphetamine abstinence syndrome: study protocol for a pragmatic randomized controlled trial