Clinical trial NCT04714840: Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
Official title: Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Childhood Cancer
Mobility Limitation
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-01-19
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise Capacity
timeFrame: Baseline to Week 20
measure: Exercise capacity
timeFrame: Week 20 to 6 months after week 20
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, week 20, 6 months after week 20
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: baseline, week 20, 6 months after week 20
measure: PROMIS Ability to Participate 8a (SF v2.0)
timeFrame: baseline, week 20, 6 months after week 20
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: baseline, week 20, 6 months after week 20
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: baseline, week 20, 6 months after week 20
measure: Medical Outcomes Survey Short Form (SF-36)
timeFrame: baseline, week 20, 6 months after week 20
measure: Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ)
timeFrame: baseline, week 20, 6 months after week 20
measure: PROMIS Global Health Short Forms
timeFrame: weekly during the first eight weeks and every four weeks during weeks 9-20
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten Ness, PhD
role: PRINCIPAL_INVESTIGATOR
References: