NCT03852758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

5.6 years

First QC Date

February 11, 2019

Last Update Submit

March 7, 2025

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • 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

    5 years

Secondary Outcomes (4)

  • Psychological Need Satisfaction in Exercise Scale (PNSE)

    1 week, 5 weeks

  • Behavior Regulation in Exercise Questionnaire (BREQ-2)

    1 week, 5 weeks

  • Fatigue

    1 week, 5 weeks

  • Feasibility as Measured by Accelerometer-Measured Moderate to Vigorous Physical Activity (MVPA)

    5 years

Study Arms (2)

Outdoor Exercise

EXPERIMENTAL

2 sessions of outdoor exercise per week

Behavioral: Outdoor ExerciseBehavioral: Indoor Exercise

Indoor Exercise

EXPERIMENTAL

2 sessions of indoor exercise per week

Behavioral: Outdoor ExerciseBehavioral: Indoor Exercise

Interventions

2 outdoor exercise sessions per week

Indoor ExerciseOutdoor Exercise
Indoor ExerciseBEHAVIORAL

2 indoor exercise sessions per week

Indoor ExerciseOutdoor Exercise

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 25, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations