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

St. Jude Children's Research Hospital

Status: Active, not recruiting

Conditions: Childhood Cancer; Mobility Limitation

Treatments: Other: Generalized exercise recommendations (AC); Other: Exercise testing results; Other: Individually tailored exercise program (INT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04714840

CARTOXIII

U01CA246570-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 181 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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181 participants in 2 patient groups

Personalized exercise group (INTGroup)

Other group

Description:

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.

Treatment:

Other: Individually tailored exercise program (INT)

Other: Exercise testing results

Generalized exercise group, Attention Control (AC Group)

Other group

Description:

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.

Treatment:

Other: Exercise testing results

Other: Generalized exercise recommendations (AC)