Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
- Conditions
- Mobility LimitationChildhood Cancer
- Interventions
- Other: Exercise testing resultsOther: Generalized exercise recommendations (AC)Other: Individually tailored exercise program (INT)
- Registration Number
- NCT04714840
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 181
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Personalized exercise group (INTGroup) Exercise testing results 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. Generalized exercise group, Attention Control (AC Group) Generalized exercise recommendations (AC) 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. Personalized exercise group (INTGroup) Individually tailored exercise program (INT) 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. Generalized exercise group, Attention Control (AC Group) Exercise testing results 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.
- Primary Outcome Measures
Name Time Method Exercise capacity Week 20 to 6 months after week 20 Sustainability of changes in Peak VO2/2-minute step in place test in both INT and AC groups
Exercise Capacity Baseline to Week 20 Changes in Peak VO2/2-minute step in place test in both INT and AC groups
- Secondary Outcome Measures
Name Time Method PROMIS Ability to Participate 8a (SF v2.0) baseline, week 20, 6 months after week 20 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.
Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ) baseline, week 20, 6 months after week 20 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.
Patient Health Questionnaire (PHQ-9) baseline, week 20, 6 months after week 20 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.
Work and Social Adjustment Scale (WSAS) baseline, week 20, 6 months after week 20 Scale: 0-8; Not at all (minimum value = 0) to Very Severely (maximum value = 8). Higher score = worse outcome. Possible score range 0-40.
Medical Outcomes Survey Short Form (SF-36) baseline, week 20, 6 months after week 20 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.
PROMIS Global Health Short Forms weekly during the first eight weeks and every four weeks during weeks 9-20 brief global physical and mental health questionnaires; Scale: 5-point Likert scale, Excellent=5, Poor=1
Generalized Anxiety Disorder (GAD-7) baseline, week 20, 6 months after week 20 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.
Work Productivity and Activity Impairment Questionnaire (WPAI) baseline, week 20, 6 months after week 20 Scale doesn't apply to overall questionnaire. Outcomes are expressed as impairment percentages. Higher numbers = worse outcome.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States