Rectal Cancer Clinical Trial
Official title:
Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Verified date | May 2024 |
Source | Abramson Cancer Center at Penn Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 20 |
Est. completion date | March 6, 2024 |
Est. primary completion date | March 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Physical Activity Intervention | 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). | From enrollment to the end of treatment at 12 weeks. | |
Secondary | Acceptability and Participant Satisfaction with Physical Activity Intervention | Using qualitative methods, evaluate the acceptability of and satisfaction with the intervention as reported by survivors. After completion of the intervention or decision to discontinue participation, we will administer a semi-structured exit interview to evaluate the acceptability of the intervention. | From enrollment to the end of treatment after 12 weeks. | |
Secondary | Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome. | Using the Memorial Sloan Kettering bowel function instrument administered pre-post PA intervention, describe the change in total bowel symptom score in the pilot cohort. | At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention. |
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