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

March 31, 2026 updated by: St. Jude Children's Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: Baseline to Week 20
Changes in Peak VO2/2-minute step in place test in both INT and AC groups
Baseline to Week 20
Exercise capacity
Time Frame: 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
Week 20 to 6 months after week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: 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.
baseline, week 20, 6 months after week 20
Generalized Anxiety Disorder (GAD-7)
Time Frame: 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.
baseline, week 20, 6 months after week 20
PROMIS Ability to Participate 8a (SF v2.0)
Time Frame: 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.
baseline, week 20, 6 months after week 20
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: 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.
baseline, week 20, 6 months after week 20
Work and Social Adjustment Scale (WSAS)
Time Frame: 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.
baseline, week 20, 6 months after week 20
Medical Outcomes Survey Short Form (SF-36)
Time Frame: 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.
baseline, week 20, 6 months after week 20
Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ)
Time Frame: 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.
baseline, week 20, 6 months after week 20
PROMIS Global Health Short Forms
Time Frame: 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
weekly during the first eight weeks and every four weeks during weeks 9-20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Jude Children's Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirsten Ness, PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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