Late Side-effects After Cervical Cancer Treatment - Prevention and Treatment

NCT06786091 | Enrolling By Invitation

• 2 other identifiers: 2340972023/FO426546
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Late side-effects following gynecological cancer are predominantly symptoms from the pelvic region originating from the bowels, urinary tract, lymphatic system, genitals and musculoskeletal system. Pelvic floor dysfunctions such as urinary- and anal incontinence, pelvic organ prolapse, vaginal stenosis as well as compromised sexual function and dyspareunia appear to be highly prevalent. The incidence of gynecological cancer in Norway was 1700 in 2020 and the survival rate in Norway is among the highest in the world. Most women with cervical cancers are treated with curative intension and life expectancy at 5 years after diagnosis is \>80%. A negative impact of pelvic floor disorders on psychosocial well-being and quality of life are seen in survivors of gynecological cancer, and in cancer survivors this is found to be directly linked with patients regaining continence. Pelvic floor muscle training has few or no side effects, and is acknowledged as first line treatment for all types of urinary incontinence in women. Even though less studied, there is evidence to support pelvic floor muscle training as a safe intervention to reduce symptoms of anal incontinence and improve sexual function. A recent comparative cross-sectional study found that survivors of gynecological cancer with dyspareunia had higher stiffness and lower flexibility, coordination and endurance of the pelvic floor muscles compared to women with a history of total hysterectomy but no pelvic pain. These findings suggest a possible role for pelvic floor muscle training in the prevention and treatment of pelvic floor disorders after gynecological cancer. However, the overall quality of evidence for strengthening the pelvic floor muscles to reduce symptoms of pelvic floor dysfunctions after treatment of gynecological cancer is low. This study aims to assess the feasibility of a digital pelvic floor rehabilitation programme led by an experienced pelvic floor physiotherapist. Study subjects are women treated for cervical cancer within the past 5 years, and all included participants will receive the intervention due to the feasibility design. Participants will be assessed clinically at baseline and endpoint, partly to ensure proper pelvic floor muscle contraction. The digital intervention ensures residents in rural areas equal access to specialized pelvic floor rehabilitation.

Conditions

Pelvic Floor Disorder; Female Pelvic Floor Dysfunction; Female Sexual Dysfunction; Female Urinary Incontinence; Fecal Incontinence; Secondary Lymphedema; Pelvic Pain

Keywords

feasibility studies; cervical cancer; pelvic floor muscle training; quality of life; pelvic floor morphology; pelvic floor muscle strength

Outcome Measures

Primary Outcomes (4)

• Feasibility - participants willingness to be included

  Participants willingness to be included (measured by inclusion rate i.e. how many are included out of the total number asked)

  The time frame is pre-defined as one year recruitment period

• Adherence - participants adherence to the intervention

  Participants adherence to the intervention, measured by how many group exercises they part-take in out of the total number of 32 group exercises

  From enrollment until the end of the treatment at 16 weeks

• Compliance to home exercises

  Participants compliance to the intervention. Participants are encouraged to do home exercises 3 times weekly (equals 48 exercise sessions over the intervention period). This is measured through reports in their training diary.

  From enrollment until the end of the treatment at 16 weeks

• Participants impression of change

  Participants impression of change following the intervention, measured by the Patient Global Impression of Change. Scale from 1-7, higher score indicating better outcome.

  From enrollment until the end of the treatment at 16 weeks

Secondary Outcomes (17)

• Symptoms of urinary incontinence

  From enrollment until the end of the treatment at 16 weeks

• Symptoms and severity of anal incontinence

  From enrollment until the end of the treatment at 16 weeks

• Symptoms of bowel dysfunction

  From enrollment until the end of the treatment at 16 weeks

• Symptoms of sexual dysfunction

  From enrollment until the end of the treatment at 16 weeks

• Pelvic pain symptoms

  From baseline clinical examination until endpoint clinical examination (after 16 weeks intervention)

Study Arms (1)

Digital pelvic floor exercise group

EXPERIMENTAL

Other: Pelvic floor muscle training rehabilitation

Interventions

Pelvic floor muscle training rehabilitation OTHER

The intervention consists of both exercise training, including pelvic floor muscle training, and information about the use of a dilator. At the baseline assessment participants are individually instructed in correct voluntary pelvic floor muscle contractions and how to perform intensive pelvic floor muscle training. The pelvic floor rehabilitation is supported with written information. The exercise program is provided with supervised digital group exercise sessions twice weekly and a home exercise program 4-5 weekly for 16 weeks. The home exercise program will be individualized if needed. The pelvic floor muscle training is following the recommendations for effective training dosage i.e. 3 sets of 10-12 repetitions, 5-7 times per week.

Digital pelvic floor exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed and treated for cervical cancer (surgery, radiation- or chemo therapy) within the last five years
• Cancer stadium I-III
• Adequate knowledge in Norwegian.

You may not qualify if:

• \- Previous pelvic radiation therapy or pelvic surgery.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Sykehuset Ostfold: collaborator

Study Sites (2)

St.Olavs University Hopsital

Trondheim, Trøndelag, 7030, Norway

Location

Østfold Hospital

Fredrikstad, Østfold fylke, 1714, Norway

Location

Related Publications (58)

• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

  PMID: 22504191 BACKGROUND

• Deutekom M, Dobben AC, Dijkgraaf MG, Terra MP, Stoker J, Bossuyt PM. Costs of outpatients with fecal incontinence. Scand J Gastroenterol. 2005 May;40(5):552-8. doi: 10.1080/00365520510012172.

  PMID: 16036507 BACKGROUND

• Xu X, Menees SB, Zochowski MK, Fenner DE. Economic cost of fecal incontinence. Dis Colon Rectum. 2012 May;55(5):586-98. doi: 10.1097/DCR.0b013e31823dfd6d.

  PMID: 22513438 BACKGROUND

• Bjerre Trent P, Falk RS, Staff AC, Jorde D, Eriksson AG. Translation and cross-cultural adaptation of the Gynecologic Cancer Lymphedema Questionnaire and the Lower Extremity Lymphedema Screening Questionnaire. Int J Gynecol Cancer. 2023 Feb 6;33(2):231-235. doi: 10.1136/ijgc-2022-003979.

  PMID: 36600491 BACKGROUND

• Eidenberger M. Patient-Reported Outcome Measures With Secondary Lower Limb Lymphedemas: A Systematic Review. J Adv Pract Oncol. 2021 Mar;12(2):174-187. doi: 10.6004/jadpro.2021.12.2.5. Epub 2021 Mar 1.

  PMID: 34109049 BACKGROUND

• Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

  PMID: 20046623 BACKGROUND

• Abrams D, Davidson M, Harrick J, Harcourt P, Zylinski M, Clancy J. Monitoring the change: current trends in outcome measure usage in physiotherapy. Man Ther. 2006 Feb;11(1):46-53. doi: 10.1016/j.math.2005.02.003.

  PMID: 15886046 BACKGROUND

• Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.

  PMID: 30793414 BACKGROUND

• Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.

  PMID: 26535150 BACKGROUND

• Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.

  PMID: 11858978 BACKGROUND

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, 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 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 BACKGROUND

• DeRogatis L, Pyke R, McCormack J, Hunter A, Harding G. Does the Female Sexual Distress Scale-Revised cover the feelings of women with HSDD? J Sex Med. 2011 Oct;8(10):2810-5. doi: 10.1111/j.1743-6109.2011.02385.x. Epub 2011 Jul 19.

  PMID: 21771282 BACKGROUND

• Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.

  PMID: 18042215 BACKGROUND

• Derogatis LR, Rosen R, Leiblum S, Burnett A, Heiman J. The Female Sexual Distress Scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther. 2002 Jul-Sep;28(4):317-30. doi: 10.1080/00926230290001448.

  PMID: 12082670 BACKGROUND

• Saga S, Stafne SN, Dons V, Bratlie I, Spetalen S, Hagemann CT. Amsterdam complex pelvic pain symptom scale with subscales: Based on a Norwegian translation, psychometric assessment and modification of the Amsterdam hyperactive pelvic floor scale. Acta Obstet Gynecol Scand. 2023 Oct;102(10):1409-1423. doi: 10.1111/aogs.14665. Epub 2023 Sep 7.

  PMID: 37675780 BACKGROUND

• Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009 Jan;116(1):25-31. doi: 10.1111/j.1471-0528.2008.01903.x. Epub 2008 Oct 8.

  PMID: 18947342 BACKGROUND

• Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.

  PMID: 9862829 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Bø KM, S;. Pelvic floor and exercise science. In: Bø KB, B; Mørkved, S; Van Kampen, M, editor. Evicence-based physical therapy for the pelvic floor Bridging science and clinical practice: Elsevier; 2015.

  BACKGROUND

• Bø K, Hagen R, Kvarstein B, Jørgensen J, Larsen S, Burgio K. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: III. Effects of two different degrees of pelvic floor muscle exercises. Neurourol Urodyn. 1990;9(5):489-502

  BACKGROUND

• Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Morin M. Characterizing Pelvic Floor Muscle Function and Morphometry in Survivors of Gynecological Cancer Who Have Dyspareunia: A Comparative Cross-Sectional Study. Phys Ther. 2021 Apr 4;101(4):pzab042. doi: 10.1093/ptj/pzab042.

  PMID: 33522584 BACKGROUND

• Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.

  PMID: 28005595 BACKGROUND

• Tennfjord MK, Engh ME, Bo K. An intra- and interrater reliability and agreement study of vaginal resting pressure, pelvic floor muscle strength, and muscular endurance using a manometer. Int Urogynecol J. 2017 Oct;28(10):1507-1514. doi: 10.1007/s00192-017-3290-y. Epub 2017 Mar 16.

  PMID: 28299404 BACKGROUND

• Tritter JQ, Calnan M. Cancer as a chronic illness? Reconsidering categorization and exploring experience. Eur J Cancer Care (Engl). 2002 Sep;11(3):161-5. doi: 10.1046/j.1365-2354.2002.00345.x.

  PMID: 12296831 BACKGROUND

• Hazewinkel MH, Sprangers MA, Taminiau-Bloem EF, van der Velden J, Burger MP, Roovers JP. Reasons for not seeking medical help for severe pelvic floor symptoms: a qualitative study in survivors of gynaecological cancer. BJOG. 2010 Jan;117(1):39-46. doi: 10.1111/j.1471-0528.2009.02411.x.

  PMID: 19874292 BACKGROUND

• Teunissen D, van Weel C, Lagro-Janssen T. Urinary incontinence in older people living in the community: examining help-seeking behaviour. Br J Gen Pract. 2005 Oct;55(519):776-82.

  PMID: 16212853 BACKGROUND

• Shaw C, Tansey R, Jackson C, Hyde C, Allan R. Barriers to help seeking in people with urinary symptoms. Fam Pract. 2001 Feb;18(1):48-52. doi: 10.1093/fampra/18.1.48.

  PMID: 11145628 BACKGROUND

• Margalith I, Gillon G, Gordon D. Urinary incontinence in women under 65: quality of life, stress related to incontinence and patterns of seeking health care. Qual Life Res. 2004 Oct;13(8):1381-90. doi: 10.1023/B:QURE.0000040794.77438.cf.

  PMID: 15503833 BACKGROUND

• Fakhrian K, Sauer T, Dinkel A, Klemm S, Schuster T, Molls M, Geinitz H. Chronic adverse events and quality of life after radiochemotherapy in anal cancer patients. A single institution experience and review of the literature. Strahlenther Onkol. 2013 Jun;189(6):486-94. doi: 10.1007/s00066-013-0314-5. Epub 2013 May 2.

  PMID: 23636349 BACKGROUND

• Jensen NBK, Potter R, Kirchheiner K, Fokdal L, Lindegaard JC, Kirisits C, Mazeron R, Mahantshetty U, Jurgenliemk-Schulz IM, Segedin B, Hoskin P, Tanderup K; EMBRACE Collaborative Group. Bowel morbidity following radiochemotherapy and image-guided adaptive brachytherapy for cervical cancer: Physician- and patient reported outcome from the EMBRACE study. Radiother Oncol. 2018 Jun;127(3):431-439. doi: 10.1016/j.radonc.2018.05.016. Epub 2018 Jun 4.

  PMID: 29880222 BACKGROUND

• Elshahat S, Treanor C, Donnelly M. Factors influencing physical activity participation among people living with or beyond cancer: a systematic scoping review. Int J Behav Nutr Phys Act. 2021 Apr 6;18(1):50. doi: 10.1186/s12966-021-01116-9.

  PMID: 33823832 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.

  PMID: 22895961 BACKGROUND

• Bonner C, Nattress K, Anderson C, Carter J, Milross C, Philp S, Juraskova I. Chore or priority? Barriers and facilitators affecting dilator use after pelvic radiotherapy for gynaecological cancer. Support Care Cancer. 2012 Oct;20(10):2305-13. doi: 10.1007/s00520-011-1337-z. Epub 2011 Dec 8.

  PMID: 22160621 BACKGROUND

• Haddad NC, Soares Brollo LC, Pinho Oliveira MA, Bernardo-Filho M. Diagnostic Methods for Vaginal Stenosis and Compliance to Vaginal Dilator Use: A Systematic Review. J Sex Med. 2021 Mar;18(3):493-514. doi: 10.1016/j.jsxm.2020.12.013. Epub 2021 Jan 29.

  PMID: 33526400 BACKGROUND

• Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev. 2014 Sep 8;2014(9):CD007291. doi: 10.1002/14651858.CD007291.pub3.

  PMID: 25198150 BACKGROUND

• Brennen R, Lin KY, Denehy L, Frawley HC. The Effect of Pelvic Floor Muscle Interventions on Pelvic Floor Dysfunction After Gynecological Cancer Treatment: A Systematic Review. Phys Ther. 2020 Aug 12;100(8):1357-1371. doi: 10.1093/ptj/pzaa081.

  PMID: 32367126 BACKGROUND

• Li J, Huang J, Zhang J, Li Y. A home-based, nurse-led health program for postoperative patients with early-stage cervical cancer: A randomized controlled trial. Eur J Oncol Nurs. 2016 Apr;21:174-80. doi: 10.1016/j.ejon.2015.09.009. Epub 2015 Oct 21.

  PMID: 26482004 BACKGROUND

• Rutledge TL, Rogers R, Lee SJ, Muller CY. A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors. Gynecol Oncol. 2014 Jan;132(1):154-8. doi: 10.1016/j.ygyno.2013.10.024. Epub 2013 Oct 29.

  PMID: 24183730 BACKGROUND

• Yang EJ, Lim JY, Rah UW, Kim YB. Effect of a pelvic floor muscle training program on gynecologic cancer survivors with pelvic floor dysfunction: a randomized controlled trial. Gynecol Oncol. 2012 Jun;125(3):705-11. doi: 10.1016/j.ygyno.2012.03.045. Epub 2012 Apr 1.

  PMID: 22472463 BACKGROUND

• Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study. Gynecol Oncol. 2020 Dec;159(3):778-784. doi: 10.1016/j.ygyno.2020.09.001. Epub 2020 Oct 1.

  PMID: 33010968 BACKGROUND

• Bernard S, Moffet H, Plante M, Ouellet MP, Leblond J, Dumoulin C. Pelvic-Floor Properties in Women Reporting Urinary Incontinence After Surgery and Radiotherapy for Endometrial Cancer. Phys Ther. 2017 Apr 1;97(4):438-448. doi: 10.1093/ptj/pzx012.

  PMID: 28201796 BACKGROUND

• Hoff Braekken I, Majida M, Engh ME, Bo K. Morphological changes after pelvic floor muscle training measured by 3-dimensional ultrasonography: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):317-324. doi: 10.1097/AOG.0b013e3181cbd35f.

  PMID: 20093905 BACKGROUND

• Ferreira CH, Dwyer PL, Davidson M, De Souza A, Ugarte JA, Frawley HC. Does pelvic floor muscle training improve female sexual function? A systematic review. Int Urogynecol J. 2015 Dec;26(12):1735-50. doi: 10.1007/s00192-015-2749-y. Epub 2015 Jun 14.

  PMID: 26072126 BACKGROUND

• Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003882. doi: 10.1002/14651858.CD003882.pub4.

  PMID: 22161382 BACKGROUND

• Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

  PMID: 30288727 BACKGROUND

• Gerharz EW, Mansson A, Hunt S, Skinner EC, Mansson W. Quality of life after cystectomy and urinary diversion: an evidence based analysis. J Urol. 2005 Nov;174(5):1729-36. doi: 10.1097/01.ju.0000176463.40530.05.

  PMID: 16217273 BACKGROUND

• Porter MP, Penson DF. Health related quality of life after radical cystectomy and urinary diversion for bladder cancer: a systematic review and critical analysis of the literature. J Urol. 2005 Apr;173(4):1318-22. doi: 10.1097/01.ju.0000149080.82697.65.

  PMID: 15758789 BACKGROUND

• Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.

  PMID: 29395269 BACKGROUND

• Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol. 2010 Nov;203(5):514.e1-7. doi: 10.1016/j.ajog.2010.08.004. Epub 2010 Sep 24.

  PMID: 20869691 BACKGROUND

• Neron M, Bastide S, Tayrac R, Masia F, Ferrer C, Labaki M, Boileau L, Letouzey V, Huberlant S. Impact of gynecologic cancer on pelvic floor disorder symptoms and quality of life: an observational study. Sci Rep. 2019 Feb 19;9(1):2250. doi: 10.1038/s41598-019-38759-5.

  PMID: 30783163 BACKGROUND

• Schofield C, Newton RU, Cohen PA, Galvao DA, McVeigh JA, Mohan GR, Tan J, Salfinger SG, Straker LM, Peddle-McIntyre CJ. Health-related quality of life and pelvic floor dysfunction in advanced-stage ovarian cancer survivors: associations with objective activity behaviors and physiological characteristics. Support Care Cancer. 2018 Jul;26(7):2239-2246. doi: 10.1007/s00520-018-4069-5. Epub 2018 Feb 1.

  PMID: 29392481 BACKGROUND

• Lindgren A, Dunberger G, Enblom A. Experiences of incontinence and pelvic floor muscle training after gynaecologic cancer treatment. Support Care Cancer. 2017 Jan;25(1):157-166. doi: 10.1007/s00520-016-3394-9. Epub 2016 Sep 5.

  PMID: 27596267 BACKGROUND

• Osann K, Hsieh S, Nelson EL, Monk BJ, Chase D, Cella D, Wenzel L. Factors associated with poor quality of life among cervical cancer survivors: implications for clinical care and clinical trials. Gynecol Oncol. 2014 Nov;135(2):266-72. doi: 10.1016/j.ygyno.2014.08.036. Epub 2014 Sep 3.

  PMID: 25192629 BACKGROUND

• Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018 Apr;29(4):459-476. doi: 10.1007/s00192-017-3467-4. Epub 2017 Sep 19.

  PMID: 28929201 BACKGROUND

• Sekse RJT, Dunberger G, Olesen ML, Osterbye M, Seibaek L. Lived experiences and quality of life after gynaecological cancer-An integrative review. J Clin Nurs. 2019 May;28(9-10):1393-1421. doi: 10.1111/jocn.14721. Epub 2019 Jan 11.

  PMID: 30461101 BACKGROUND

• Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6.

  PMID: 12903007 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Fecal Incontinence; Pelvic Pain; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• Signe Nilssen Stafne

  St. Olavs University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 22, 2025
• Study Start: February 4, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)