Symptoms and General Pathology

All Conditions

Mobility Limitation

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.

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.

Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.

Exercise testing results

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.

Individually tailored exercise program (INT)

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.

Generalized exercise recommendations (AC)

Kirsten Ness, PhD

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.

The design for this study will be a single-blind two-arm, prospective, randomized clinical trial. Performance testing results: Both groups of participants will be provided with the results of their performance testing. Individually tailored exercise program: Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist.Generalized exercise recommendations: Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans.

Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Changes in Peak VO2/2-minute step in place test in both INT and AC groups

Sustainability of changes in Peak VO2/2-minute step in place test in both INT and AC groups

Scale: 4 Options - Not at all (minimum value = 0), Several days (1), More than half the days (2), Nearly every day (maximum value = 3). Higher score = worse outcome. Possible score range is 0-27.

Scale: 5 Options - Not at all sure (minimum value = 0), Several days (1), Over half the days (2), Nearly every day (maximum value = 3). Higher score = worse outcome. Possible score range is 0-21.

Scale: 5 Options - Never (maximum value = 5), Rarely (4), Sometimes (3), Usually (2), Always (minimum value = 1). Higher score = better outcome. Possible score range 8-40.

Scale doesn't apply to overall questionnaire. Outcomes are expressed as impairment percentages. Higher numbers = worse outcome.

Scale: 0-8; Not at all (minimum value = 0) to Very Severely (maximum value = 8). Higher score = worse outcome. Possible score range 0-40.

Consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher score = better outcome.

Scale: 3 Options - Never a Problem (maximum value = 2), Sometimes a Problem (1) , Often a Problem (minimum value = 0). Higher score = better outcome. Possible score range 0-64.

brief global physical and mental health questionnaires; Scale: 5-point Likert scale, Excellent=5, Poor=1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance	NCT04714840	Childhood Cance... Mobility Limita...	Exercise testin... Individually ta... Generalized exe...	18 Years - 39 Years	St. Jude Children's Research Hospital
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance	NCT04714840	Childhood Cance... Mobility Limita...	Exercise testin... Individually ta... Generalized exe...	18 Years - 39 Years	St. Jude Children's Research Hospital
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance	NCT04714840	Childhood Cance... Mobility Limita...	Exercise testin... Individually ta... Generalized exe...	18 Years - 39 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for individually tailored exercise program (int)