Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

NCT03781154 | Completed Phase 3 DMC

• 2 other identifiers: 18-2436.cc131629-MRSG-18-021- 01-CPPB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colorectal Cancer

Keywords

Physical activity; Survivors; Maintenance; Personal Training; Group Mediated Cognitive Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Physical Fitness: Aerobic

  From baseline to 12-weeks and 6-months post intervention

• Physical Fitness: Strength and Endurance

  From baseline to 12-weeks and 6 months post intervention

• Body Composition

  From baseline to 12-weeks 6 months post intervention

• Body Composition

  From baseline to 12 weeks

• Sleep Quality

  From baseline to 12 weeks

Study Arms (2)

Group-based exercise

EXPERIMENTAL

Virtually-delivered supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components.

Behavioral: Group Exercise

Control Group

NO INTERVENTION

A physical activity education control group

Interventions

Group Exercise BEHAVIORAL

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.

Group-based exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision to sign and date the consent form
• Fluent in English
• Have access to a computer or phone with internet and a camera
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Be a male or female aged 40 years or older at time of diagnosis
• Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
• Completed resection or other surgery 3-24 months prior to enrollment
• 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.

You may not qualify if:

• Current evidence of metastatic disease
• Existing participation in ≥150 minutes per week of at least moderate intensity PA
• Known contraindications for exercise or not able to safely participate in exercise
• Pregnant women (no testing required)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Cancer Society, Inc.: collaborator
• Colorado State University: collaborator

Study Sites (4)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 800524, United States

Location

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Harmony Campus

Fort Collins, Colorado, 80528, United States

Location

Related Publications (1)

• Bachman SL, Gomes E, Aryal S, Cella D, Clay I, Lyden K, Leach HJ. Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis. JMIR Cancer. 2024 Jul 15;10:e53180. doi: 10.2196/53180.

  PMID: 39008350 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Wells Messersmith, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI and study staff conducting assessments at study visits will be blinded to study arm assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: October 17, 2019
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)