Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
NCT ID: NCT04714840
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
181 participants
INTERVENTIONAL
2021-02-08
2026-03-01
Brief Summary
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Primary Objectives:
To achieve the goal of this study, we propose the following three Objectives:
Primary Objective 1:
To determine the efficacy of an individually tailored, home-delivered aerobic and strengthening intervention to improve exercise capacity in survivors of childhood cancer with exercise intolerance (peak oxygen uptake (peak VO2) \<85% of age and sex predicted).
Primary Objective 2:
To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on measures of cardiac, pulmonary, musculoskeletal, and neurosensory function in survivors of childhood cancer with exercise intolerance.
Primary Objective 3:
To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on emotional health, participation in family and community activities, quality of life, and cognitive function in survivors of childhood cancer with exercise intolerance.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Personalized exercise group (INTGroup)
Participants in this group have individually tailored exercise program with supervision, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.
Exercise testing results
Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.
Individually tailored exercise program (INT)
Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist. Written instructions, videos of each strengthening exercise, a blue tooth enable heart rate monitor, all necessary exercise equipment, and an iPad pre-loaded with heart rate monitor software, exercise videos and ZOOM app (for video conferencing) will be provided. After returning home, the exercise specialist will supervise and provide guidance to the individual via the ZOOM app during the first 2 weeks (3 sessions per week). Supervision will slowly decrease to twice a week in weeks 3-4, once a week in weeks 5-8, every other week in weeks 9-16, and to one time midway between weeks 17-20. The exercise program will be adjusted depending on the individuals progress.
Generalized exercise group, Attention Control (AC Group)
Study participants in this group receive generalized exercise recommendations, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.
Exercise testing results
Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.
Generalized exercise recommendations (AC)
Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans. At the baseline visit, a study staff will review these guidelines and answer questions about their exercise testing and encourage them to be physically active. The staff will contact them via telephone to complete a short questionnaire weekly during weeks 1-8 and monthly for weeks 9-20.
Interventions
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Exercise testing results
Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.
Individually tailored exercise program (INT)
Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist. Written instructions, videos of each strengthening exercise, a blue tooth enable heart rate monitor, all necessary exercise equipment, and an iPad pre-loaded with heart rate monitor software, exercise videos and ZOOM app (for video conferencing) will be provided. After returning home, the exercise specialist will supervise and provide guidance to the individual via the ZOOM app during the first 2 weeks (3 sessions per week). Supervision will slowly decrease to twice a week in weeks 3-4, once a week in weeks 5-8, every other week in weeks 9-16, and to one time midway between weeks 17-20. The exercise program will be adjusted depending on the individuals progress.
Generalized exercise recommendations (AC)
Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans. At the baseline visit, a study staff will review these guidelines and answer questions about their exercise testing and encourage them to be physically active. The staff will contact them via telephone to complete a short questionnaire weekly during weeks 1-8 and monthly for weeks 9-20.
Eligibility Criteria
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Inclusion Criteria
* SJLIFE participant
* Peak VO2 \<85% predicted
* Verbalizes understanding of directions for use of ZOOM on the study provided iPad and heart rate monitor
* Clearance for participation in exercise by a study physician
* Internet access
Exclusion Criteria
* Self-report of engaging in \> 150 minutes/week of moderate physical activity
* Currently pregnant (assess by urine pregnancy test)
* Significant psychological distress (e.g. suicidal ideation)
* Requires immediate medical intervention (e.g. angina, decompensated heart failure)
* Research Participant Recruitment and Screening
18 Years
39 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Kirsten Ness, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Maharaj A, Jefferies JL, Mulrooney DA, Armstrong GT, Brinkman TM, O'Neil ST, Terrell S, Partin RE, Srivastava DK, Hudson MM, Wang Z, Ness KK. Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Contemp Clin Trials. 2023 Oct;133:107339. doi: 10.1016/j.cct.2023.107339. Epub 2023 Sep 18.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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CARTOXIII
Identifier Type: -
Identifier Source: org_study_id