Top

Published in:

Open Access 01-12-2023 | Urinary Incontinence | Study Protocol

Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study

Authors: Ching Hui Chien, Kuan Lin Liu, Chun Te Wu, Cheng Keng Chuang, Kai Jie Yu, Po Hung Lin, Xuan Yi Huang, See Tong Pang

Published in: BMC Urology | Issue 1/2023

Abstract

Background

Urinary incontinence is a common complication among patients with prostate cancer who have undergone radical prostatectomy. Guided by social cognitive theory and a framework for the recovery of health and well-being, we propose to develop and test a self-management intervention for patients with prostate cancer who experience urinary incontinence after undergoing radical prostatectomy.

Methods

In this study, a self-management intervention for urinary incontinence (SMI-UI) is developed, comprising a mobile self-management application, a self-management handbook, and professional support. The feasibility, acceptability, and effectiveness of this intervention will be assessed. Patient data from the urology departments of two hospitals will be collected through convenience sampling by adopting an experimental, parallel, and random assignment research design. Patients experiencing urinary incontinence after undergoing radical prostatectomy will be invited to participate. After completing the pretest questionnaire, patients will be randomly divided into the experimental and attention control groups. The experimental group will undergo a 12-week SMI-UI, whereas the attention control group will receive an intervention consisting of a single dietetic education information package. The two groups will be tested 12 and 16 weeks after the pretest. In this study, we recorded the sociodemographic and clinical variables; recruitment rate; retention rate; satisfaction with the intervention; cancer-related self-efficacy; urination symptoms and disturbance; social participation and satisfaction; resilience; and demoralization.

Trial Registration

ClinicalTrials.gov ID: NCT05335967 [date of registration 04-04-2022].

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. https://doi.org/10.3322/caac.21660.CrossRefPubMed

National Comprehensive Cancer Network (NCCN). Prostate Cancer Version 1. 2023; 2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.

Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, et al. Quality of life and satisfaction with outcome among Prostate-cancer survivors. N Engl J Med. 2008;358(12):1250–61. https://doi.org/10.1056/NEJMoa074311.CrossRefPubMed

Eilat-Tsanani S, Tabenkin H, Shental J, Elmalah I, Steinmetz D. Patients’ perceptions of radical prostatectomy for localized Prostate cancer: a qualitative study. Isr Med Assoc J. 2013;15(3):153–7.PubMed

Wennerberg C, Schildmeijer K, Hellström A, Ekstedt M. Patient experiences of self-care management after radical prostatectomy. Eur J Oncol Nurs. 2021;50:101894. https://doi.org/10.1016/j.ejon.2020.101894.CrossRefPubMed

Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Tsay PK, Chang YH, Huang XY, Liu HE. Effects of individual and partner factors on anxiety and depression in Taiwanese Prostate cancer patients: a longitudinal study. Eur J Cancer Care (Engl). 2018;27(2):e12753. https://doi.org/10.1111/ecc.12753.CrossRefPubMed

Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Chang YH. Positive and negative affect and prostate cancer-specific anxiety in Taiwanese patients and their partners. Eur J Oncol Nurs. 2018;37:1–11. https://doi.org/10.1016/j.ejon.2018.09.004.CrossRefPubMed

Ignatius J, Garza IIRDL. Frequency of demoralization and depression in cancer patients. Gen Hosp Psychiatry. 2019;60:137–40. https://doi.org/10.1016/j.genhosppsych.2019.04.013.CrossRefPubMed

Nanni MG, Caruso R, Travado L, Ventura C, Palma A, Berardi AM, Meggiolaro E, Ruffilli F, Martins C, Kissane D, et al. Relationship of demoralization with anxiety, depression, and quality of life: a southern European study of Italian and Portuguese cancer patients. Psychooncology. 2018;27(11):2616–22. https://doi.org/10.1002/pon.4824.CrossRefPubMed

10.

Chien CH, Chuang CK, Liu KL, Huang XY, Liu HE. Psychosocial adjustments in patients with Prostate cancer from pre-diagnosis to 6 months post-treatment. Int J Nurs Pract. 2016;22(1):70–8. https://doi.org/10.1111/ijn.12360.CrossRefPubMed

11.

Corner J, Wagland R, Glaser A, Richards SM. Qualitative analysis of patients’ feedback from a PROMs survey of cancer patients in England. BMJ Open. 2013;3(4). https://doi.org/10.1136/bmjopen-2012-002316.

12.

Chien CH, Pang ST, Chuang CK, Liu KL, Wu CT, Yu KJ, Huang XY, Lin PH. Exploring psychological resilience and demoralisation in Prostate cancer survivors. Eur J Cancer Care (Engl). 2022;31(6):e13759. https://doi.org/10.1111/ecc.13759.CrossRefPubMed

13.

Sharpley CF, Bitsika V, Christie DRH, Bradford R, Steigler A, Denham JW. Psychological resilience aspects that mediate the depressive effects of urinary incontinence in Prostate cancer survivors 10 years after treatment with radiation and hormone ablation. J Psychosoc Oncol. 2017;35(4):438–50. https://doi.org/10.1080/07347332.2017.1306733.CrossRefPubMed

14.

Faithfull S, Cockle-Hearne J, Khoo V. Self-management after Prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms. BJU Int. 2011;107(5):783–90. https://doi.org/10.1111/j.1464-410X.2010.09588.x.CrossRefPubMed

15.

Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-management in long-term Prostate cancer survivors: a randomized, controlled trial. J Clin Oncol. 2019;37(15):1326–35. https://doi.org/10.1200/JCO.18.01770.

16.

Martín-Núñez J, Heredia-Ciuró A, Valenza-Peña G, Granados-Santiago M, Hernández-Hernández S, Ortiz-Rubio A, Valenza MC. Systematic review of self-management programs for Prostate cancer patients, a quality of life and self-efficacy meta-analysis. Patient Educ Couns. 2023;107:107583. https://doi.org/10.1016/j.pec.2022.107583.CrossRefPubMed

17.

Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklöf A. Engagement in an interactive app for symptom self-management during treatment in patients with breast or Prostate cancer: mixed methods study. J Med Internet Res. 2020;22(8):e17058. https://doi.org/10.2196/17058.CrossRefPubMedPubMedCentral

18.

Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1–7. https://doi.org/10.1207/S15324796ABM2601_01.CrossRefPubMed

19.

Xu A, Wang Y, Wu X. Effectiveness of e-health based self-management to improve cancer-related fatigue, self-efficacy and quality of life in cancer patients: systematic review and meta-analysis. J Adv Nurs. 2019;75(12):3434–47. https://doi.org/10.1111/jan.14197.CrossRefPubMed

20.

Lambert SD, Duncan LR, Culos-Reed SN, Hallward L, Higano CS, Loban E, Katz A, De Raad M, Ellis J, Korman MB, et al. Feasibility, acceptability, and clinical significance of a dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO) tailored to the needs of men with Prostate cancer and their caregivers: a multi-center randomized pilot trial. Curr Oncol. 2022;29(2):785–804. https://doi.org/10.3390/curroncol29020067.CrossRefPubMedPubMedCentral

21.

Murphy KM, Sauer C, Yang D, Hass N, Novakovic K, Helfand B, Nadler R, Schalet BD, Victorson D. The development of iManage-PC, an online symptom monitoring and self-management tool for men with clinically localized Prostate cancer. Cancer Nurs. 2022;45(1):E309–e19. https://doi.org/10.1097/NCC.0000000000000948.CrossRefPubMedPubMedCentral

22.

Paterson C, Primeau C, Pullar I, Nabi G. Development of a prehabilitation multimodal supportive care interventions for men and their partners before radical prostatectomy for localized Prostate cancer. Cancer Nurs. 2019;42(4):E47–e53. https://doi.org/10.1097/NCC.0000000000000618.CrossRefPubMed

23.

Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, Kresevic D, Moore S, Ponsky L, Purdum M, Strauss G, et al. Effects of patient centered interventions on persistent urinary incontinence after Prostate cancer treatment: a randomized, controlled trial. J Urol. 2015;194(6):1675–81. https://doi.org/10.1016/j.juro.2015.07.090.CrossRefPubMedPubMedCentral

24.

Cockle-Hearne J, Barnett D, Hicks J, Simpson M, White I, Faithfull S. A web-based intervention to reduce distress after Prostate cancer treatment: development and feasibility of the getting down to coping program in two different clinical settings. JMIR Cancer. 2018;4(1):e8. https://doi.org/10.2196/cancer.8918.CrossRefPubMedPubMedCentral

25.

Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized Prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021;15(1):99–108. https://doi.org/10.1007/s11764-020-00914-7.CrossRefPubMed

26.

Kazer MW, Bailey DE Jr., Sanda M, Colberg J, Kelly WK. An internet intervention for management of uncertainty during active surveillance for Prostate cancer. Oncol Nurs Forum. 2011;38(5):561–8. https://doi.org/10.1188/11.ONF.561-568.CrossRefPubMed

27.

Nilsson L, Hellström A, Wennerberg C, Ekstedt M, Schildmeijer K. Patients’ experiences of using an e-Health tool for self-management support after Prostate cancer Surgery: a deductive interview study explained through the FITT framework. BMJ Open. 2020;10(6):e035024. https://doi.org/10.1136/bmjopen-2019-035024.CrossRefPubMedPubMedCentral

28.

Zhang X, Deng Z, Parvinzamir F, Dong F. MyHealthAvatar lifestyle management support for cancer patients. Ecancermedicalscience. 2018;12:849. https://doi.org/10.3332/ecancer.2018.849.CrossRefPubMedPubMedCentral

29.

Obro LF, Osther PJS, Ammentorp J, Pihl GT, Heiselberg KK, Krogh PG, Handberg C. An intervention Offering Self-management support through mHealth and health coaching to patients with Prostate Cancer: interpretive description of patients’ experiences and perspectives. JMIR Form Res. 2022;6(9):e34471. https://doi.org/10.2196/34471.CrossRefPubMedPubMedCentral

30.

Bowler M, Dehek R, Thomas E, Ngo K, Grose L. Evaluating the impact of post-treatment self-management guidelines for Prostate cancer survivors. J Med Imaging Radiat Sci. 2019;50(3):398–407. https://doi.org/10.1016/j.jmir.2019.03.182.CrossRefPubMed

31.

Frankland J, Brodie H, Cooke D, Foster C, Foster R, Gage H, Jordan J, Mesa-Eguiagaray I, Pickering R, Richardson A. Follow-up care after treatment for Prostate cancer: evaluation of a supported self-management and remote surveillance programme. BMC Cancer. 2019;19(1):368. https://doi.org/10.1186/s12885-019-5561-0.CrossRefPubMedPubMedCentral

32.

Paterson C, Roberts C, Toohey K, McKie A. Prostate cancer prehabilitation and the importance of multimodal interventions for person-centred care and recovery. Semin Oncol Nurs. 2020;36(4):151048. https://doi.org/10.1016/j.soncn.2020.151048.CrossRefPubMed

33.

Glanz K, Rimer BK, Viswanath K. Health Behavior: theory, Research, and practice. 5th ed. USA: Jossey-Bass; 2015.

34.

Duijts SFA, Bleiker EMA, Paalman CH, van der Beek AJ. A behavioural approach in the development of work-related interventions for cancer survivors: an exploratory review. Eur J Cancer Care (Engl). 2017;26(5). https://doi.org/10.1111/ecc.12545.

35.

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191–215. https://doi.org/10.1037/0033-295X.84.2.191.CrossRefPubMed

36.

Schwarzer R, Warner LM. Perceived self-efficacy and its relationship to resilience. In: Resilience in children, adolescents, and adults. edn. Edited by Prince-Embury S, Saklofske DH. New York: Springer; 2013;139 – 50. https://doi.org/10.1007/978-1-4614-4939-3_10.

37.

Bandura A. Self-efficacy: the exercise of control. New York: W.H. Freeman and Company; 1997.

38.

Foster C, Breckons M, Cotterell P, Barbosa D, Calman L, Corner J, Fenlon D, Foster R, Grimmett C, Richardson A, et al. Cancer survivors’ self-efficacy to self-manage in the year following primary treatment. J Cancer Surviv. 2015;9(1):11–9. https://doi.org/10.1007/s11764-014-0384-0.CrossRefPubMed

39.

Foster C, Fenlon D. Recovery and self-management support following primary cancer treatment. Br J Cancer. 2011;105(Suppl 1):21–8. https://doi.org/10.1038/bjc.2011.419.CrossRef

40.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

41.

Aycock DM, Hayat MJ, Helvig A, Dunbar SB, Clark PC. Essential considerations in developing attention control groups in behavioral research. Res Nurs Health. 2018;41(3):320–8. https://doi.org/10.1002/nur.21870.CrossRefPubMed

42.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–55.CrossRefPubMed

43.

Walters SJ, Henriques-Cadby BDA, Bortolami I, Flight O, Hind L, Jacques D, Knox RM, Nadin C, Rothwell B, Surtees J. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276. https://doi.org/10.1136/bmjopen-2016-015276.CrossRefPubMedPubMedCentral

44.

Liu KL, Chuang CK, Pang ST, Wu CT, Yu KJ, Tsai SC, Chien CH. Emotional state and cancer-related self-efficacy as affecting resilience and quality of life in kidney cancer patients: a cross-sectional study. Support Care Cancer. 2022;30(3):2263–71. https://doi.org/10.1007/s00520-021-06644-5.CrossRefPubMed

45.

Foster C, Breckons M, Hankins M, Fenlon D, Cotterell P. Developing a scale to measure self-efficacy to SELF-manage problems following cancer treatment. Psychooncology. 2013;22(Supp 1):16.

46.

Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded Prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with Prostate cancer. Urology. 2000;56(6):899–905. https://doi.org/10.1016/s0090-4295(00)00858-x.CrossRefPubMed

47.

Chien CH, Chuang CK, Liu KL, Huang XY, Pang ST, Wu CT, Chang YH, Liu HE. Individual and mutual predictors of marital satisfaction among Prostate cancer patients and their spouses. J Clin Nurs. 2017;26(23–24):4994–5003. https://doi.org/10.1111/jocn.13998.CrossRefPubMed

48.

Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-Davidson Resilience Scale (CD-RISC): validation of a 10-item measure of resilience. J Trauma Stress. 2007;20(6):1019–28. https://doi.org/10.1002/jts.20271.CrossRefPubMed

49.

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76–82. https://doi.org/10.1002/da.10113.CrossRefPubMed

50.

Meng M, He J, Guan Y, Zhao H, Yi J, Yao S, Li L. Factorial invariance of the 10-item Connor-Davidson Resilience Scale across gender among Chinese elders. Front Psychol. 2019;10:1237. https://doi.org/10.3389/fpsyg.2019.01237.CrossRefPubMedPubMedCentral

51.

Hung HC, Chen HW, Chang Y-F, Yang YC, Liu CL, Hsieh R-K, Leu YS, Chen YJ, Wang T-E, Tsai LY, et al. Evaluation of the reliability and validity of the Mandarin version of demoralization scale for cancer patients. J Intern Med Taiwan. 2010;21:427–35. https://doi.org/10.6314/JIMT.2010.21(6).06.CrossRef

52.

Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The demoralization scale: a report of its development and preliminary validation. J Palliat Care. 2004;20(4):269–76. https://doi.org/10.1177/082585970402000402.CrossRefPubMed

53.

Lee HM. The preliminary study on measure of elder’ meaning in life and related factors. J SHU-TE Univ. 2013;15(1):125–54.

54.

Brubaker L. Patient education: Pelvic floor muscle exercises (Beyond the Basics); 2021. Available from: UpToDate.

55.

Clemens JQ. Urinary incontinence in men; 2022. Available from: UpToDate.

56.

Comiter CV, Speed J. Urinary incontinence after prostate treatment; 2021. Available from: UpToDate.

57.

Feng D, Liu S, Li D, Han P, Wei W. Analysis of conventional versus advanced pelvic floor muscle training in the management of urinary incontinence after radical prostatectomy: a systematic review and meta-analysis of randomized controlled trials. Transl Androl Urol. 2020;9(5):2031–45. https://doi.org/10.21037/tau-20-615.CrossRefPubMedPubMedCentral

58.

Klein EA. Radical prostatectomy for localized prostate cancer; 2020. Available from: UpToDate.

59.

Lukacz ES. Treatment of urinary incontinence in females; 2021. Available from: UpToDate.

60.

McConnell KE, Corbin CB, Corbin DE, Farrar TD. Health for life. United States: Human Kinetics; 2014.

61.

Strączyńska A, Weber-Rajek M, Strojek K, Piekorz Z, Styczyńska H, Goch A, Radzimińska A. The impact of pelvic floor muscle training on urinary incontinence in men after radical prostatectomy (RP) - a systematic review. Clin Interv Aging. 2019;14:1997–2005. https://doi.org/10.2147/cia.S228222.CrossRefPubMedPubMedCentral

62.

Van de Zutter VD, Satink F, Costa T, Janquart U, Senn S, De Vriendt D. Delineating the concept of self-management in chronic conditions: a concept analysis. BMJ Open. 2019;9(7):e027775. https://doi.org/10.1136/bmjopen-2018-027775.CrossRefPubMedPubMedCentral

63.

Chien CH, Chung HJ, Liu KL, Pang ST, Wu CT, Chang YH, Huang XY, Chang YH, Lin TP, Lin WY, et al. Effectiveness of a couple-based psychosocial intervention on patients with Prostate cancer and their partners: a quasi-experimental study. J Adv Nurs. 2020;76(10):2572–85. https://doi.org/10.1111/jan.14471.CrossRefPubMed

64.

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

65.

Zhu J, Ebert L, Liu X, Wei D, Chan SW. Mobile Breast cancer e-support program for Chinese women with Breast cancer undergoing chemotherapy (part 2): Multicenter randomized controlled trial. JMIR Mhealth Uhealth. 2018;6(4):e104. https://doi.org/10.2196/mhealth.9438.CrossRefPubMedPubMedCentral

66.

Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149–60. https://doi.org/10.3758/brm.41.4.1149.CrossRefPubMed

67.

Crutzen R, Viechtbauer W, Spigt M, Kotz D. Differential attrition in health behaviour change trials: a systematic review and meta-analysis. Psychol Health. 2015;30(1):122–34. https://doi.org/10.1080/08870446.2014.953526.CrossRefPubMed

68.

Dhada S, Stewart D, Cheema E, Hadi MA, Paudyal V. Cancer services during the COVID-19 pandemic: systematic review of patient’s and caregiver’s experiences. Cancer Manag Res. 2021;13:5875–87. https://doi.org/10.2147/cmar.S318115.CrossRefPubMedPubMedCentral

Title: Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study
Authors: Ching Hui Chien
Kuan Lin Liu
Chun Te Wu
Cheng Keng Chuang
Kai Jie Yu
Po Hung Lin
Xuan Yi Huang
See Tong Pang
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Urinary Incontinence
Urinary Incontinence
Prostate Cancer
Prostate Cancer
Prostatectomy
Prostatectomy
Published in: BMC Urology / Issue 1/2023
Electronic ISSN: 1471-2490
DOI: https://doi.org/10.1186/s12894-023-01367-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study

Abstract

Background

Methods

Trial Registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Trial Registration

Please log in to get access to this content

Other articles of this Issue 1/2023

Atherosclerosis of the iliac arteries for the prediction of erectile dysfunction and epistaxis in men undergoing abdominal CT scan

Clinical characteristics and treatment outcomes of kidney transplant recipients with de novo urothelial carcinoma: thirty years of experience from a single center

Updated recommendations on the therapeutic role of extracorporeal shock wave therapy for peyronie’s disease: systematic review and meta-analysis

Declaration: Novel SLC3A1 mutation in a cystinuria patient with xanthine stones: a case report

Predictive value of systematic immune-inflammation index combined with Ki-67 index on prognosis of prostate cancer patients after laparoscopic radical prostatectomy

Efficacy and safety of minimally invasive percutaneous nephrolithotomy versus retrograde intrarenal surgery in the treatment of upper urinary tract stones (> 1 cm): a systematic review and meta-analysis of 18 randomized controlled trials