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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Hematoietic Cell Transplant
Childhood Cancer

Treatments

Behavioral: Indoor Exercise
Behavioral: Outdoor Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03852758
FMCH-2018-27298

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

13 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

19 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jonathan Miller, PhD

Data sourced from clinicaltrials.gov

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