Physical Activity in Rectal Cancer Survivors
- Conditions
- Rectosigmoid CancerRectal Cancer
- Interventions
- Other: Physical ActivityOther: SurveyBehavioral: Telehealth Lifestyle Coaching
- Registration Number
- NCT06435975
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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
- Detailed Description
The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- Patients failing to meet all the above inclusion criteria will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Survey Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity. Experimental Physical Activity Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity. Experimental Telehealth Lifestyle Coaching Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.
- Primary Outcome Measures
Name Time Method Feasibility of Physical Activity Intervention From enrollment to the end of treatment at 12 weeks. 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 Outcome Measures
Name Time Method Acceptability and Participant Satisfaction with Physical Activity Intervention From enrollment to the end of treatment after 12 weeks. 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.
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. At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention. 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.
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States