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

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer; Mobility Limitation
• Intervention / Treatment: Other: Exercise testing results; Other: Individually tailored exercise program (INT); Other: Generalized exercise recommendations (AC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsten Ness, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Kirsten Ness, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Kirsten Ness, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Personalized exercise group (INTGroup); 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.	Other: Exercise testing results; Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.; Other: Individually tailored exercise program (INT); 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.
Other: Generalized exercise group, Attention Control (AC Group); 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.	Other: Exercise testing results; Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.; Other: Generalized exercise recommendations (AC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Changes in Peak VO2/2-minute step in place test in both INT and AC groups	Baseline to Week 20
Exercise capacity	Sustainability of changes in Peak VO2/2-minute step in place test in both INT and AC groups	Week 20 to 6 months after week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	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.	baseline, week 20, 6 months after week 20
Generalized Anxiety Disorder (GAD-7)	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.	baseline, week 20, 6 months after week 20
PROMIS Ability to Participate 8a (SF v2.0)	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.	baseline, week 20, 6 months after week 20
Work Productivity and Activity Impairment Questionnaire (WPAI)	Scale doesn't apply to overall questionnaire. Outcomes are expressed as impairment percentages. Higher numbers = worse outcome.	baseline, week 20, 6 months after week 20
Work and Social Adjustment Scale (WSAS)	Scale: 0-8; Not at all (minimum value = 0) to Very Severely (maximum value = 8). Higher score = worse outcome. Possible score range 0-40.	baseline, week 20, 6 months after week 20
Medical Outcomes Survey Short Form (SF-36)	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.	baseline, week 20, 6 months after week 20
Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ)	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.	baseline, week 20, 6 months after week 20
PROMIS Global Health Short Forms	brief global physical and mental health questionnaires; Scale: 5-point Likert scale, Excellent=5, Poor=1	weekly during the first eight weeks and every four weeks during weeks 9-20

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kirsten Ness, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: CARTOXIII; U01CA246570-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No