Clinical trial NCT06435975: Physical Activity in Rectal Cancer Survivors
Official title: Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Rectosigmoid Cancer
Keywords: Rectal Cancer
Physical Activity
Bowel Dysfunction
Telehealth
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Physical Activity Intervention
timeFrame: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes:
measure: Acceptability and Participant Satisfaction with Physical Activity Intervention
timeFrame: From enrollment to the end of treatment after 12 weeks.
measure: 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.
timeFrame: At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Erica Pettke, MD, MPH, FACS
role: PRINCIPAL_INVESTIGATOR
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