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Trial record 1 of 1 for:    Leach | Colorectal Cancer
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Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03781154
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society, Inc.
Colorado State University
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study is a two-arm trial, comparing the effects of a 12-week GMCB exercise intervention vs. a 1:1 individually supervised exercise intervention on PA maintenance in colorectal cancer survivors, and explore multi-level determinants of PA maintenance, 12-months after intervention completion.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: 1:1 Training Behavioral: Group Exercise Phase 3

Detailed Description:
Participants will be prospectively assigned or allocated to either a GMCB exercise intervention or 1:1 supervised exercise (i.e. personal training) for 12 weeks. Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Exercise will be individualised based on the results of baseline fitness assessments and medical history, and will be modified to accommodate ostomy or stoma (e.g. refrain from exercises that increase intraabdominal pressure to avoid herniation, avoid crunching or curling motions with colostomy bag).In the GMCB intervention, group size will be 5-15 participants to optimize social interaction, and activities will be structured so that participants come in close proximal distance of each other at least once per session (e.g. circuit training, squat with ball toss to a partner). There will be scheduled opportunities for social interaction (e.g. water breaks at least 3 times during class, partner 'get to know you' questions during aerobic exercise, etc.), and group roles will be assigned for class participants (e.g. leading warm up or stretching). Discussion sessions will be based on Social Cognitive Theory, and will target PA maintenance. In both groups, discussion sessions will last 30-60 minutes, and will be held following an exercise session in Weeks 1, 4, 7, 9, and 12. Topics will include benefits of PA specific to colorectal cancer survivors, identifying and overcoming barriers to PA, and strategies for independent exercise (e.g. goal setting, self-monitoring). In the GMCB intervention, discussion sessions will be group-based, and further facilitate group cohesion via activities such as personal introductions, group PA goal setting, group problem solving, creation of a group name/identity, and design of group t-shirts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be prospectively assigned or allocated to either a GMCB exercise intervention or 1:1 supervised exercise (i.e. personal training) for 12 weeks.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: PI and study staff conducting assessments at study visits will be blinded to study arm assignment.
Primary Purpose: Supportive Care
Official Title: Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individually Supervised exercise
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: 1:1 Training
Patients will exercise with a personal trainer for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with their trainer 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.

Experimental: Group-based exercise
Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components.Group size will be 5-15 participants to optimize social interaction, and activities will be structured so that participants come in close proximal distance of each other at least once per session (e.g. circuit training, squat with ball toss to a partner). There will be scheduled opportunities for social interaction (e.g. water breaks at least 3 times during class, partner 'get to know you' questions during aerobic exercise, etc.), and group roles will be assigned for class participants (e.g. leading warm up or stretching).
Behavioral: Group Exercise
Patients will exercise in a group of 5 to 15 for 60 minutes, twice a week. Fivesocial-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 Outcome Measures :
  1. Physical Activity [ Time Frame: From baseline to 12 months post intervention, up to 4 years ]
    Compare the efficacy of a 12-week physical activity intervention delivered in group versus one-on-one, on long-term physical activity adherence. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer.


Secondary Outcome Measures :
  1. Physical Fitness: Aerobic [ Time Frame: From baseline to 12 months post intervention, up to 4 years ]
    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 months post intervention, up to 4 years ]
    Muscular strength & endurance will be assessed by various weight training activities.

  3. Body Composition [ Time Frame: From baseline to post-intervention, up to 12 weeks ]
    Assessed by waist circumference

  4. Body Composition [ Time Frame: From baseline to post-intervention, up 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 post-intervention, up 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 months post intervention, up to 4 years ]
    Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision to sign and date the consent form
  2. Fluent in English
  3. Stated willingness to comply with all study procedures and be available for the duration of the study
  4. Be a male or female aged 40 years or older at time of diagnosis
  5. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
  6. Completed resection or other surgery 3-24 months prior to enrollment
  7. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781154


Contacts
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Contact: Heather Leach, PhD 970-491-8951 heather.leach@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Heather Leach, PhD    970-491-8951    heather.leach@ucdenver.edu   
Colorado State University Not yet recruiting
Fort Collins, Colorado, United States, 80523
Contact: Heather Leach, PhD    970-491-8951    heather.leach@ucdenver.edu   
Principal Investigator: Heather Leach, PhD         
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
American Cancer Society, Inc.
Colorado State University
Investigators
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Principal Investigator: Heather Leach, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03781154    
Other Study ID Numbers: 18-2436.cc
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Physical activity
Survivors
Maintenance
Personal Training
Group Mediated Cognitive Behavior
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases