Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer Wit… (NCT04714840) | Clinical Trial Compass
CompletedNot Applicable
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
United States181 participantsStarted 2021-02-08
Plain-language summary
The participants are asked to take part in this clinical trial, a type of research study. The participants are SJLIFE study participants and may have a hard time exercising (exercise intolerance) due to side effects of cancer treatment received as a child.This study is being done to determine if a personalized exercise plan will help childhood cancer survivors who have exercise intolerance become more active.
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.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 18.00 and 39.99 years of age at the time of enrollment
* 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:
* Enrolled in a formal exercise intervention
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.