Physical Activity in Rectal Cancer Survivors

NCT06435975 | Completed

• 2 other identifiers: UPCC 20221849585
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Complete surveys to assess bowel function and quality of life
2. 2.Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
3. 3.Perform daily physical activity

Conditions

Rectal Cancer; Rectosigmoid Cancer

Keywords

Rectal Cancer; Physical Activity; Bowel Dysfunction; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability and Participant Satisfaction with Physical Activity Intervention

  From enrollment to the end of treatment after 12 weeks.

• 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.

Study Arms (1)

Experimental

EXPERIMENTAL

Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.

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

Interventions

Physical Activity OTHER

Participants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise.

Experimental

Survey OTHER

Participants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey.

Experimental

Telehealth Lifestyle Coaching BEHAVIORAL

Participants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (26)

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  PMID: 39714033 DERIVED

Related Links

• American Cancer Society. Cancer Facts \& Figures 2020
• 2018 Physical Activity Guidelines for Americans. US Department of Health and Human Services; 2008

MeSH Terms

Conditions

Rectal Neoplasms; Motor Activity; Intestinal Diseases

Interventions

Exercise; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erica Pettke, MD, MPH, FACS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2022
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

US (1)