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Trial record 5 of 197 for:    colon cancer | ( Map: Colorado, United States )

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 : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study is a two-arm, randomized controlled trial, comparing the effects of a 12-week group-based physical activity intervention to a 1:1 supervised physical activity (i.e. personal training) on long-term physical activity adherence.

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

Detailed Description:

Colorectal cancer survivors report some of the lowest levels of PA of any survivor group, and increasing physical activity in colorectal cancer survivors presents an enormous opportunity to improve cancer control and survivorship outcomes. Previous interventions have addressed the need to increase PA in colorectal cancer survivors, but only one study has targeted long-term, sustainable PA behavior change in this population. It may take considerable time for PA to impact physiological, psychological and survival outcomes, and therefore interventions should find ways to facilitate long-term physical activity once the intervention ends.

One strategy that has been successful for increasing long-term physical activity adherence in many other populations is group mediated cognitive-behavioral (GMCB) physical activity interventions. GMCB PA interventions deliver PA in a group-based format, use behavior change strategies based on social cognitive theory, and capitalize on group dynamics as a mechanism of change.Group-dynamics target the group's environment, structure and processes, with the goal of fostering group cohesion. Group cohesion is associated with physical activity adherence and long-term maintenance in many populations. In colorectal cancer survivors, this type of intervention may be particularly effective for increasing physical activity and quality of life by offering a new network of social support, and the opportunity to be surrounded by others with a shared experience.

Without supportive social and physical environments, many individuals return to previous low PA levels after an intervention is complete, and it is theorized that in order to achieve long-term maintenance of physical activity, a multi-level approach is needed. Built environment characteristics such as walkability, and access to parks and recreation facilities are also associated with physical activity, and for colorectal cancer survivors, the type of built environment support that is important for PA may differ from the general population due to physical limitations (e.g. multiple co-morbid contentions, ostomy and stoma) that affect their physical activity abilities.

The objectives of this research project are:

Aim 1: Compare the effects of a 12-week GMCB physical activity intervention to an individually supervised intervention on PA maintenance in colorectal cancer survivors.

Aim 2: Examine the effects of a 12-week GMCB physical activity intervention and an individually supervised intervention on physical fitness, QOL, and sleep quality in colorectal cancer survivors.

Aim 3: Explore individual, social, and environmental factors that are associated with physical activity maintenance, 12-months after intervention completion.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to either one on one exercise with a personal trainer or they will be randomized to Group Mediated Cognitive Behavior (GMCB) exercise
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. Four 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. Four 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 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:   50 Years to 80 Years   (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 50-80
  5. Histologically confirmed cancer of the colon or rectum (stages II-III)
  6. Completed resection or other surgery 3-24 months prior to enrollment
  7. Received and completed any chemotherapy and/or radiation within one the previous year

Exclusion Criteria:

  1. 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
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     History of Changes
Other Study ID Numbers: 18-2436.cc
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
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
Randomized
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases