Childhood CancerGECCOSNCT03852758
Green Exercise for Cancer - Creating Opportunities for Survivors
A study testing Outdoor Exercise and Indoor Exercise in people with Childhood Cancer and Hematoietic Cell Transplant, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Childhood Cancer, Hematoietic Cell Transplant
- What is being tested?
- Outdoor Exercise and Indoor Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Anyone not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Cancer, Hematoietic Cell Transplant
- Being tested
- Outdoor Exercise, Indoor Exercise
- Keywords
- exercise
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor ExerciseBehavioural
2 outdoor exercise sessions per week
Indoor ExerciseBehavioural
2 indoor exercise sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Outdoor Exercise | Experimental | 2 sessions of outdoor exercise per week Receives: Behavioral: Outdoor Exercise; Behavioral: Indoor Exercise |
| Indoor Exercise | Experimental | 2 sessions of indoor exercise per week Receives: Behavioral: Outdoor Exercise; Behavioral: Indoor Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by number of participants recruited
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
Measured: 5 years
Secondary outcomes (4)
Psychological Need Satisfaction in Exercise Scale (PNSE)
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.
Measured: 1 week, 5 weeks
Behavior Regulation in Exercise Questionnaire (BREQ-2)
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
Measured: 1 week, 5 weeks
Fatigue
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.
Measured: 1 week, 5 weeks
Feasibility as Measured by Accelerometer-Measured Moderate to Vigorous Physical Activity (MVPA)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 May 2019
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852758
- Sponsor's protocol ID
- FMCH-2018-27298
- Acronym
- GECCOS
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2019
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller JM, Sadak KT, Shahriar AA, Wilson NJ, Hampton M, Bhattacharya M, Towle A, Turcotte LM. Cancer survivors exercise at higher intensity in outdoor settings: The GECCOS trial. Pediatr Blood Cancer. 2021 May;68(5):e28850. doi: 10.1002/pbc.28850. Epub 2020 Dec 23.
PubMed 33369068
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Exercise for Cancer - Creating Opportunities for Survivors: Pilot Trial (GECCOS-PILOT)
- ClinicalTrials.gov ID
- NCT03852758
- Acronym / sponsor ID
- GECCOS / FMCH-2018-27298
- Conditions
- Childhood Cancer, Hematoietic Cell Transplant
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor Exercise | Experimental | Behavioral: Outdoor Exercise, Behavioral: Indoor Exercise2 sessions of outdoor exercise per week |
| Indoor Exercise | Experimental | Behavioral: Outdoor Exercise, Behavioral: Indoor Exercise2 sessions of indoor exercise per week |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Anyone not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor Exercise2 outdoor exercise sessions per week | Behavioural | Indoor Exercise, Outdoor Exercise |
| Indoor Exercise2 indoor exercise sessions per week | Behavioural | Indoor Exercise, Outdoor Exercise |
Primary outcome
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
4 secondary outcomes
Psychological Need Satisfaction in Exercise Scale (PNSE)
Time frame: 1 week, 5 weeks
Behavior Regulation in Exercise Questionnaire (BREQ-2)
Time frame: 1 week, 5 weeks
Fatigue
Time frame: 1 week, 5 weeks
Feasibility as Measured by Accelerometer-Measured Moderate to Vigorous Physical Activity (MVPA)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 33369068Miller JM, Sadak KT, Shahriar AA, Wilson NJ, Hampton M, Bhattacharya M, Towle A, Turcotte LM. Cancer survivors exercise at higher intensity in outdoor settings: The GECCOS trial. Pediatr Blood Cancer. 2021 May;68(5):e28850. doi: 10.1002/pbc.28850. Epub 2020 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Exercise and Indoor Exercise in people with Childhood Cancer and Hematoietic Cell Transplant, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of participants recruited (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.