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Green Exercise for Cancer - Creating Opportunities for Survivors (GECCOS)

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ClinicalTrials.gov Identifier: NCT03852758
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to assess feasibility and acceptability for a trial to evaluate exercise behaviors, fatigue and exercise motivation in adolescent and young adult survivors of childhood cancer who participate in an outdoor exercise intervention compared to survivors who participate in an indoor exercise intervention. A pilot randomized cross over design will allow participants to be compared to traditional controls as well as self-controls.

Condition or disease Intervention/treatment Phase
Childhood Cancer Hematoietic Cell Transplant Behavioral: Outdoor Exercise Behavioral: Indoor Exercise Not Applicable

Detailed Description:

Title: Green Exercise for Cancer - Creating Opportunities for Survivors (GECCOS)

Rationale: Exercise is related to lower rates of late effects like fatigue, heart disease and second cancers among survivors of childhood cancer. Yet levels of exercise remain low among survivors. The context where exercise occurs - indoors or outdoors - may affect motivation to exercise and sustained exercise behavior. Yet the effects of exercise context on motivation and maintained behavior remain unexamined. This study aims to pilot test an outdoor exercise intervention for cancer survivors compared to attention controls receiving an indoor exercise intervention.

Target Population: Adolescent (13 to 17 years) and young adult (18 to 30 years) survivors of any cancer or hematopoietic cell transplantation for non-malignant disease.

Number of Participants :

16 to 20 participants (8 to 10 adolescents, 8 to 10 young adults).

Objective:

Pilot test, for feasibility and acceptability, a novel outdoor exercise intervention to motivate and maintain exercise in adolescent and young adult survivors of childhood cancer. Using a randomized cross-over design, participants will randomly receive both indoor and outdoor exercise sessions.

Study Design:

Randomized Cross-over Pilot Trial

Measures of Interest:

Primary Outcome - Accelerometer measured moderate to vigorous physical activity.

Secondary Outcomes - Self-Determination Theory based measures of motivation to exercise from validated survey questions. Fatigue, measured with validated survey questions.

Semi-structured qualitative exit interview will be used to assess acceptability and feasibility of the intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Green Exercise for Cancer - Creating Opportunities for Survivors: Pilot Trial (GECCOS-PILOT)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Outdoor Exercise
2 sessions of outdoor exercise per week
Behavioral: Outdoor Exercise
2 outdoor exercise sessions per week

Behavioral: Indoor Exercise
2 indoor exercise sessions per week

Experimental: Indoor Exercise
2 sessions of indoor exercise per week
Behavioral: Outdoor Exercise
2 outdoor exercise sessions per week

Behavioral: Indoor Exercise
2 indoor exercise sessions per week




Primary Outcome Measures :
  1. Feasibility as measured by number of participants recruited [ Time Frame: 5 years ]
    Assess feasibility by determining if at least 16 participants from a sample from of 319 can be recruited to participate in the community based exercise sessions


Secondary Outcome Measures :
  1. Psychological Need Satisfaction in Exercise Scale (PNSE) [ Time Frame: 1 week, 5 weeks ]
    PNSE is an 18 item validated survey measurement that assesses the Self-Determination Theory constructs of perceived autonomy, competence and relatedness. Scale measures agreement (scale from 1 (I do not agree) to 7 (I very strongly agree)) with statements pertaining to exercise. Subscales of autonomy, competence, and relatedness sum to the composite score. Changes in individual subscales will be considered as well as changes in the composite score. The competence subscale ranges from 5 to 30 with higher scores indicating greater feelings of competence. The autonomy subscale ranges from 7 to 42 with higher scores indicating greater feelings of autonomy. The relatedness subscale ranges from 6 to 36 with higher scores indicating greater feelings of relatedness. The final composite score is the sum of the subscales and ranges from 18 to 108 with higher score indicating greater needs satisfaction.

  2. Behavior Regulation in Exercise Questionnaire (BREQ-2) [ Time Frame: 1 week, 5 weeks ]
    BREQ- 2 is a 19 item validated survey measurement that assesses the Self-Determination Theory construct of exercise motivation. Scale measures agreement (scale from 0 (not true for me) to 4 (very true for me)) with statements pertaining to exercise. Subscales of amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation are weighted and summed to the composite score. Changes in individual subscales will be considered as well as changes in the composite score. The introjected motivation subscale ranges from 0 to 12 with higher values indicating more introjected regulation motivation. All other subscales range from 0 to 16 with higher values indicating more endorsement of the motivation type measured. A final composite score is calculated by summing the sub-scales after applying weights of -3 for amotivation, -2 for external regulation, -1 for introjected regulation, 2 for identified reg

  3. Fatigue [ Time Frame: 1 week, 5 weeks ]
    Fatigue Scale - Adolescent (Appendix A): The revised Fatigue Scale - Adolescent (FS-A) is a 13 item validated survey measurement that assesses fatigue. Scale measures frequency of fatigue symptoms (scale from 1 (not at all) to 5 (all of the time)). There are no subscales. The FS-A score range from 13 to 65 with higher score indicating greater symptoms of fatigue.

  4. Feasibility as Measured by Accelerometer-Measured Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 5 years ]
    Assess feasibility and acceptability of an outdoor exercise intervention for survivors of childhood cancer. Multiple factors may be considered when determining feasibility and acceptability with MVPA measured by accelerometer being the main factor.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Survivors of childhood cancer or hematopoietic cell transplantation for non-malignant diseases
  • Between the ages of 13 and 30
  • Able to speak English
  • More than 3 months out from the completion of cancer treatment and/or 6 months out from hematopoietic cell transplantation with no evidence of recurrent or residual cancer
  • Must be off of all immune suppressing therapies

Exclusion Criteria:

  • Anyone not meeting the inclusion criteria

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): NCT03852758


Contacts
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Contact: Jonathan Miller, PhD 651-247-5096 mill5687@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jonathan Miller, PhD    651-247-5096    mill5687@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03852758     History of Changes
Other Study ID Numbers: GECCOS-PILOT
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: May 17, 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 Minnesota - Clinical and Translational Science Institute:
exercise