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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Cytostatic Therapy | Study protocol

Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial

Authors: Daniëlle L. van de Graaf, Floortje Mols, Hester R. Trompetter, Marije L. van der Lee, Karlein M. G. Schreurs, Elin Børøsund, Lise Solberg Nes, Tom Smeets

Published in: Trials | Issue 1/2022

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Abstract

Background

About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention.

Methods

A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention.

Discussion

This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients.

Trial registration

ClinicalTrials.gov NCT05371158. Registered on May 12, 2022.
Protocol version: version 1, 24-05-2022
Appendix
Available only for authorised users
Literature
1.
Heins M, Schellevis F, Rijken M, Van Der Hoek L, Korevaar J. Determinants of increased primary health care use in cancer survivors. J Clin Oncol. 2012;30(33):4155–60.PubMedCrossRef
2.
3.
Elferink MAG, Van Steenbergen LN, Krijnen P, Lemmens VEPP, Rutten HJ, Marijnen CAM, et al. Marked improvements in survival of patients with rectal cancer in the Netherlands following changes in therapy, 1989-2006. Eur J Cancer. 2010;46(8):1421–9.PubMedCrossRef
4.
Van Steenbergen LN, Lemmens VEPP, Rutten HJT, Wymenga ANM, Nortier JWR, Janssen-Heijnen MLG. Increased adjuvant treatment and improved survival in elderly stage III colon cancer patients in the Netherlands. Ann Oncol. 2012;23(11):2805–11.PubMedCrossRef
5.
Sukel MPP, van de Poll-Franse LV, Nieuwenhuijzen GAP, Vreugdenhil G, Herings RMC, Coebergh JWW, et al. Substantial increase in the use of adjuvant systemic treatment for early stage breast cancer reflects changes in guidelines in the period 1990-2006 in the southeastern Netherlands. Eur J Cancer. 2008;44(13):1846–54.PubMedCrossRef
6.
7.
Mols F, Beijers T, Vreugdenhil G, Van De Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014;22(8):2261–9.PubMedCrossRef
8.
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, Macleod MR, et al. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. Pain. 2014;155(12):2461–70.PubMedCrossRef
9.
10.
11.
12.
Beijers AJM, Jongen JLM, Vreugdenhil G. Chemotherapy-induced neurotoxicity: The value of neuroprotective strategies. Neth J Med. 2012;70(1):18–25.PubMed
13.
Glendenning JL, Barbachano Y, Norman AR, Dearnaley DP, Horwich A, Huddart RA. Long-term neurologic and peripheral vascular toxicity after chemotherapy treatment of testicular cancer. Cancer. 2010;116(10):2322–31.PubMed
14.
Bonhof CS, Mols F, Vos MC, Pijnenborg JMA, Boll D, Vreugdenhil G, et al. Course of chemotherapy-induced peripheral neuropathy and its impact on health-related quality of life among ovarian cancer patients: a longitudinal study. Gynecol Oncol. 2018;149(3):455–63.PubMedCrossRef
15.
16.
Bao T, Basal C, Seluzicki C, Li SQ, Seidman AD, Mao JJ. Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors: prevalence, risk factors, and fall risk. Breast Cancer Res Treat. 2016;159(2):327–33.PubMedPubMedCentralCrossRef
17.
Beijers AJM, Mols F, Vreugdenhil G. A systematic review on chronic oxaliplatin-induced peripheral neuropathy and the relation with oxaliplatin administration. Support Care Cancer. 2014;22(7):1999–2007.PubMedCrossRef
18.
Tofthagen C, Donovan KA, Morgan MA, Shibata D, Yeh Y. Oxaliplatin-induced peripheral neuropathy’s effects on health-related quality of life of colorectal cancer survivors. Support Care Cancer. 2013;21:3307–13.PubMedPubMedCentralCrossRef
19.
Tofthagen C. Patient perceptions associated with chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs. 2010;14(3):E22–8.PubMedCrossRef
20.
Mols F, Beijers AJM, Lemmens V, van den Hurk CJ, Vreugdenhil G, Van De Poll-Franse LV. Chemotherapy-induced neuropathy and its association with quality of life among 2-to 11-year colorectal cancer survivors: results from the population-based PROFILES registry development of an EORTC cancer survivorship assessment strategy View project LIVE. Artic J Clin Oncol. 2013;31(21):2699–707.CrossRef
21.
Bonhof CS, Van de Poll-Franse LV, de Hingh IH, Nefs G, Vreugdenhil G, Mols F. Association between peripheral neuropathy and sleep quality among colorectal cancer patients from diagnosis until 2-year follow-up: results from the PROFILES registry. J Cancer Surviv. 2021. https://​doi.​org/​10.​1007/​s11764-021-01130-7.
22.
Bonhof CS, Trompetter HR, Vreugdenhil G, van de Poll-Franse LV, Mols F. Painful and non-painful chemotherapy-induced peripheral neuropathy and quality of life in colorectal cancer survivors: results from the population-based PROFILES registry. Support Care Cancer. 2020;28(12):5933–41.PubMedPubMedCentralCrossRef
23.
Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care. 2015;24(1):15–27.CrossRef
24.
Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psychooncology. 2013;22(2):459–64.PubMed
25.
Hayes SC, Luoma J, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: Model, processes and outcomes. Behav Res Ther. 2006;44(1):1–25.PubMedCrossRef
26.
McCracken LM, Vowles KE. Acceptance and commitment therapy and mindfulness for chronic pain model, process, and progress. Am Psychol. 2014;69(2):178.PubMedCrossRef
27.
Knoerl R, Smith EML, Barton DL, Williams DA, Holden JE, Krauss JC, et al. Self-guided online cognitive behavioral strategies for chemotherapy-induced peripheral neuropathy: a multicenter, pilot, randomized, wait-list controlled trial. J Pain. 2018;19(4):382–94.PubMedCrossRef
28.
Børøsund E, Mirkovic J, Clark M, Ehlers S, Andrykowski M, Bergland A, Westeng M, Solberg Nes L. A stress management app intervention for cancer survivors: design, development, and usability testing. JMIR Form Res. 2018;2(2):e19. https://​doi.​org/​10.​2196/​formative.​9954.
29.
Gainsbury S, Blaszczynski A. Online self-guided interventions for the treatment of problem gambling. Int Gambl Stud. 2011;11(3):289–308.CrossRef
30.
Slev VN, Mistiaen P, Pasman HRW, Leeuw IMV, van Uden-Kraan CF, Francke AL. Effects of eHealth for patients and informal caregivers confronted with cancer: a meta-review. Int J Med Inform. 2016;87:54–67.PubMedCrossRef
31.
McAlpine H, Joubert L, Martin-Sanchez F, Merolli M, Drummond KJ. A systematic review of types and efficacy of online interventions for cancer patients. Patient Educ Couns. 2015;98(3):283–95.PubMedCrossRef
32.
Kuijpers W, Groen WG, Oldenburg HS, Wouters MW, Aaronson NK, van Harten WH. eHealth for breast cancer survivors: use, feasibility and impact of an interactive portal. JMIR Cancer. 2016;2(1):e3.PubMedPubMedCentralCrossRef
33.
Trompetter HR, Bohlmeijer ET, Veehof MM, Schreurs KMG. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial. J Behav Med. 2015;38(1):66–80.PubMedCrossRef
34.
Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KMG. Acceptance-and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5–31.PubMedCrossRef
35.
Trompetter HR, Bohlmeijer ET, Lamers SMA, Schreurs KMG. Positive psychological wellbeing is required for online self-help acceptance and commitment therapy for chronic pain to be effective. Front Psychol. 2016;7:353.PubMedPubMedCentralCrossRef
36.
Lin J, Paganini S, Sander L, Lüking M, Ebert DD, Buhrman M, et al. An internet-based intervention for chronic pain: a three-arm randomized controlled study of the effectiveness of guided and unguided acceptance and commitment therapy. Dtsch Arztebl Int. 2017;114(41):681–8.PubMedPubMedCentral
37.
Baumeister H, Reichler L, Munzinger M, Lin J. The impact of guidance on Internet-based mental health interventions — a systematic review. Internet Interv. 2014;1(4):205–15.CrossRef
38.
van de Poll-Franse LV, Horevoorts N, Schoormans D, Beijer S, Ezendam NPM, Husson O, et al. Measuring clinical, biological, and behavioral variables to elucidate trajectories of patient (reported) outcomes: the PROFILES registry. J Natl Cancer Inst. 2022;114(6):800–7.
39.
Lousberg R, Van Breukelen GJP, Groenman NH, Schmidt AJM, Arntz A, Winter FAM. Psychometric properties of the Multidimensional Pain Inventory, Dutch language version (MPI-DLV). Behav Res Ther. 1999;37(2):167–82.PubMedCrossRef
40.
Kerns RD, Turk DC, Rudy TE. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain. 1985;23(4):345–56.PubMedCrossRef
41.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.PubMedCrossRef
42.
Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, et al. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005;41(8):1135–9.PubMedCrossRef
43.
Smith EML, Barton DL, Qin R, Steen PD, Aaronson NK, Loprinzi CL. Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire. Qual Life Res. 2013;22(10):2787–99.CrossRef
44.
Dworkin RRH, Turk DDCD, Farrar JTJ, Pain JH-, 2005 U, Haythornthwaite JA, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1):9–19.PubMedCrossRef
45.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073–93.PubMedCrossRef
46.
Spinhoven PH, Ormel J, Sloekers PPA, Kempen GIJM, Speckens AEM, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27:363–70.PubMedCrossRef
47.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef
48.
Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524–32.CrossRef
49.
Wicksell RK, Olsson GL, Hayes SC. Psychological flexibility as a mediator of improvement in Acceptance and Commitment Therapy for patients with chronic pain following whiplash. Eur J Pain. 2010;14(10):1059.e1–1059.e11.CrossRef
50.
Wicksell RK, Lekander M, Sorjonen K, Olsson GL. The Psychological Inflexibility in Pain Scale (PIPS) - statistical properties and model fit of an instrument to assess change processes in pain related disability. Eur J Pain. 2010;14(7):771.e1–771.e14.CrossRef
51.
Trompetter HR, Bohlmeijer ET, Van Baalen B, Kleen M, Köke A, Reneman M, et al. The Psychological Inflexibility in Pain Scale (PIPS) exploration of psychometric properties in a heterogeneous chronic pain sample. Eur J Psychol Assess. 2014;30(4):289–95.CrossRef
52.
Bruggeman-Everts FZ, Van der Lee ML, Van ‘t Hooft EFM, Nyklíček I. Validation of the Dutch Freiburg Mindfulness Inventory in patients with medical illness. SAGE Open. 2017;7(2):2158244017705936.CrossRef
53.
Trompetter HR, Ten Klooster PM, Schreurs KMG, Fledderus M, Westerhof GJ, Bohlmeijer ET. Measuring values and committed action with the Engaged Living Scale (ELS): psychometric evaluation in a nonclinical sample and a chronic pain sample. Psychol Assess. 2013;25(4):1235–46.PubMedCrossRef
54.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233–7.PubMedCrossRef
55.
56.
Eysenbach G. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13:e126.PubMedPubMedCentralCrossRef
57.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. New Jersey: Lawrence Erlbaum; 1988.
58.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21.PubMedCrossRef
59.
Turner JA, Holtzman S, Mancl L. Mediators, moderators, and predictors of therapeutic change in cognitive-behavioral therapy for chronic pain. Pain. 2007;127(3):276–86.PubMedCrossRef
60.
Hayes A. Introduction to mediation, moderation and conditional process analysis. New York: Guilford Press; 2013.
Metadata
Title
Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial
Authors
Daniëlle L. van de Graaf
Floortje Mols
Hester R. Trompetter
Marije L. van der Lee
Karlein M. G. Schreurs
Elin Børøsund
Lise Solberg Nes
Tom Smeets
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06592-3

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