Physical Activity in Rectal Cancer Survivors

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Rectosigmoid Cancer; Rectal Cancer

Treatments: Behavioral: Telehealth Lifestyle Coaching; Other: Survey; Other: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06435975

UPCC 20221

849585 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Experimental

Experimental group

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.

Treatment:

Other: Physical Activity

Other: Survey

Behavioral: Telehealth Lifestyle Coaching