Clinical trial · Interventional
Physical Activity in Rectal Cancer Survivors
Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
NCT06435975CI-TRIAL-00077612completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life. Participants will be asked to: 1. Complete surveys to assess bowel function and quality of life 2. Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction 3. Perform daily physical activity
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectosigmoid Cancer | Malignant Rectosigmoid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Activity | Other | — | UNRESOLVED |
| Survey | Other | — | UNRESOLVED |
| Telehealth Lifestyle Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.
- interventionNames
- Other: Physical Activity
- Other: Survey
- Behavioral: Telehealth Lifestyle Coaching
Primary outcomes (1)
- measure
- Feasibility of Physical Activity Intervention
- timeFrame
- From enrollment to the end of treatment at 12 weeks.
- description
- Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Stage I-III cancers of the rectum/rectosigmoid. 2. Age 18 or older 3. Three months to 5 years post-treatment completion 4. Have a rectal or anal anastomosis with a LARS score of 21-42 5. At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino) 6. Ability to be physically active and cleared by MD 7. Patients must be able to read and understand English. 8. Participants must sign the informed consent form The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue 20 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded, or additional studies may be performed to investigate those differences more fully. Exclusion Criteria: 1\. Patients failing to meet all the above inclusion criteria will be excluded from the study.
References
Publications (26)
- BACKGROUNDHendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce. PMID 16041212
- BACKGROUNDLange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7. PMID 21135876
- BACKGROUNDBruheim K, Guren MG, Skovlund E, Hjermstad MJ, Dahl O, Frykholm G, Carlsen E, Tveit KM. Late side effects and quality of life after radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1005-11. doi: 10.1016/j.ijrobp.2009.03.010. Epub 2009 Jun 18. PMID 19540058
- BACKGROUNDHoerske C, Weber K, Goehl J, Hohenberger W, Merkel S. Long-term outcomes and quality of life after rectal carcinoma surgery. Br J Surg. 2010 Aug;97(8):1295-303. doi: 10.1002/bjs.7105. PMID 20602501
- BACKGROUNDSun V, Grant M, Wendel CS, McMullen CK, Bulkley JE, Altschuler A, Ramirez M, Baldwin CM, Herrinton LJ, Hornbrook MC, Krouse RS. Dietary and Behavioral Adjustments to Manage Bowel Dysfunction After Surgery in Long-Term Colorectal Cancer Survivors. Ann Surg Oncol. 2015 Dec;22(13):4317-24. doi: 10.1245/s10434-015-4731-9. Epub 2015 Jul 10. PMID 26159443
- BACKGROUNDKrouse RS, Wendel CS, Garcia DO, Grant M, Temple LKF, Going SB, Hornbrook MC, Bulkley JE, McMullen CK, Herrinton LJ. Physical activity, bowel function, and quality of life among rectal cancer survivors. Qual Life Res. 2017 Nov;26(11):3131-3142. doi: 10.1007/s11136-017-1641-2. Epub 2017 Jul 4. PMID 28677077
- BACKGROUNDFong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.