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Completed

NCT Number: NCT03781154

Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

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.

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Physical Activity

    Time frame: From baseline to 12-weeks, and 6 months post intervention

    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.

Secondary outcomes

  1. Physical Fitness: Aerobic

    Time frame: From baseline to 12-weeks and 6-months post intervention

    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.

  2. Physical Fitness: Strength and Endurance

    Time frame: From baseline to 12-weeks and 6 months post intervention

    Muscular strength & endurance will be assessed by various weight training activities.

  3. Body Composition

    Time frame: From baseline to 12-weeks 6 months post intervention

    Assessed by waist circumference

  4. Body Composition

    Time frame: From baseline to 12 weeks

    Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)

  5. Sleep Quality

    Time frame: From baseline to 12 weeks

    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.

  6. Quality of Life Assessment

    Time frame: From baseline to 12 weeks and 6 months post intervention

    Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Cancer Society, Inc.
  • Colorado State University

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2018
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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