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

October 2, 2023 updated by: University of Minnesota

Green Exercise for Cancer - Creating Opportunities for Survivors: Pilot Trial (GECCOS-PILOT)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week, 5 weeks
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
1 week, 5 weeks
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.
1 week, 5 weeks
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMCH-2018-27298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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