NCT06435975Completed
Physical Activity in Rectal Cancer Survivors
Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Source: ClinicalTrials.gov · Last updated 30 May 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 6 May 2024
- Start date
- 1 Jun 2022
- Primary completion date
- 6 Mar 2024
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT06435975
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Jun 2022 to the primary completion date, 6 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Patients failing to meet all the above inclusion criteria will be excluded from the study.
Who the study is looking for
- Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
- Age 18 or older
- Three months to 5 years post-treatment completion
- Have a rectal or anal anastomosis with a LARS score of 21-42
- At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
- Ability to be physically active and cleared by MD
- Patients must be able to read and understand English.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.