Clinical trial NCT03852758: Green Exercise for Cancer - Creating Opportunities for Survivors
Official title: Green Exercise for Cancer - Creating Opportunities for Survivors: Pilot Trial (GECCOS-PILOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Hematoietic Cell Transplant
Keywords: exercise
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility as measured by number of participants recruited
timeFrame: 5 years
Secondary outcomes:
measure: Psychological Need Satisfaction in Exercise Scale (PNSE)
timeFrame: 1 week, 5 weeks
measure: Behavior Regulation in Exercise Questionnaire (BREQ-2)
timeFrame: 1 week, 5 weeks
measure: Fatigue
timeFrame: 1 week, 5 weeks
measure: Feasibility as Measured by Accelerometer-Measured Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 5 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: 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.