Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781154
• Other study ID #: 18-2436.cc
• Secondary ID: 131629-MRSG-18-0
• Status: Completed
• Phase: Phase 3
• Start date: October 17, 2019
• Est. completion date: June 26, 2023

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.

Description:

Participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. The control group will be provided with an informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. At the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Sessions will be delivered synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on the results of baseline fitness assessments and medical history. The intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. Discussion sessions will take place in the same groups, synchronously, via Zoom.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Provision to sign and date the consent form

2. Fluent in English

3. Have access to a computer or phone with internet and a camera

4. Stated willingness to comply with all study procedures and be available for the duration of the study

5. Be a male or female aged 40 years or older at time of diagnosis

6. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease

7. Completed resection or other surgery 3-24 months prior to enrollment

8. Received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy.

Exclusion Criteria:

1. Current evidence of metastatic disease

2. Existing participation in =150 minutes per week of at least moderate intensity PA

3. Known contraindications for exercise or not able to safely participate in exercise

4. Pregnant women (no testing required)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Group Exercise
Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Colorado State University	Fort Collins	Colorado
United States	Harmony Campus	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Cancer Society, Inc., Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Compare the effects of a 12-week physical activity intervention delivered in group versus control group, on physical activity. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer.	From baseline to 12-weeks, and 6 months post intervention
Secondary	Physical Fitness: Aerobic	Aerobic fitness will be assessed with a submaximal, graded exercise test on a motorized, calibrated treadmill. Muscular Strength & Endurance will be assessed by multiple repetition maximum (1RM) plate loaded seated bench press and leg press, and by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.	From baseline to 12-weeks and 6-months post intervention
Secondary	Physical Fitness: Strength and Endurance	Muscular strength & endurance will be assessed by various weight training activities.	From baseline to 12-weeks and 6 months post intervention
Secondary	Body Composition	Assessed by waist circumference	From baseline to 12-weeks 6 months post intervention
Secondary	Body Composition	Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)	From baseline to 12 weeks
Secondary	Sleep Quality	Assessed by a self-report measure of sleep quality using the Pittsburg Sleep Quality Index (PSQI) and through the Actiwatch, which is a wrist-worn monitor that records movement and light exposure.	From baseline to 12 weeks
Secondary	Quality of Life Assessment	Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)	From baseline to 12 weeks and 6 months post intervention