Physical Activity in Rectal Cancer Survivors

Rectal Cancer Clinical Trial

Official title:

Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06435975
• Other study ID #: UPCC 20221
• Secondary ID: 849585
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 6, 2024

Study information

• Verified date: May 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Rectosigmoid Cancer

Intervention

Other:
• Physical Activity
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.
• Survey
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.

Behavioral:
• Telehealth Lifestyle Coaching
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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Hendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce. — View Citation

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Ottenbacher A, Yu M, Moser RP, Phillips SM, Alfano C, Perna FM. Population Estimates of Meeting Strength Training and Aerobic Guidelines, by Gender and Cancer Survivorship Status: Findings From the Health Information National Trends Survey (HINTS). J Phys Act Health. 2015 May;12(5):675-9. doi: 10.1123/jpah.2014-0003. Epub 2014 May 15. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

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.

External Links

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