Childhood CancerNCT04714840

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

A study testing Exercise testing results, Individually tailored exercise program (INT) and Generalized exercise recommendations (AC) in people with Childhood Cancer and Mobility Limitation, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Childhood Cancer, Mobility Limitation
What is being tested?: Exercise testing results, Individually tailored exercise program (INT) and Generalized exercise recommendations (AC)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2021to 23 Feb 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Childhood Cancer, Mobility Limitation
Being tested: Exercise testing results, Individually tailored exercise program (INT), Generalized exercise recommendations (AC)
Medical subject headings: Neoplasms, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise testing resultsOther
Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.
Individually tailored exercise program (INT)Other
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.
Generalized exercise recommendations (AC)Other
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.

Study groups in NCT04714840
Study group	Role	What they receive
Personalized exercise group (INTGroup)	Other	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. Receives: Other: Exercise testing results; Other: Individually tailored exercise program (INT)
Generalized exercise group, Attention Control (AC Group)	Other	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. Receives: Other: Exercise testing results; Other: Generalized exercise recommendations (AC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: weekly during the first eight weeks and every four weeks during weeks 9-20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202123 Feb 2026

First posted19 Jan 2021
Study start8 Feb 2021
Primary completion15 Sep 2025
Study completion23 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Childhood CancerStudies of the same condition, open and under way.
More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04714840
Sponsor's protocol ID: CARTOXIII
Other IDs: U01CA246570-01
Status last verified: Mar 2026
First submitted: 10 Mar 2020
Last updated: 1 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Maharaj A, Jefferies JL, Mulrooney DA, Armstrong GT, Brinkman TM, O'Neil ST, Terrell S, Partin RE, Srivastava DK, Hudson MM, Wang Z, Ness KK. Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Contemp Clin Trials. 2023 Oct;133:107339. doi: 10.1016/j.cct.2023.107339. Epub 2023 Sep 18.
PubMed 37730199

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer

All Childhood Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
ClinicalTrials.gov ID: NCT04714840
Acronym / sponsor ID: CARTOXIII
Conditions: Childhood Cancer, Mobility Limitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 8 Feb 2021 (actual)
Primary completion: 15 Sep 2025 (actual)
Study completion: 23 Feb 2026 (actual)
First posted: 19 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objectives:

To achieve the goal of this study, we propose the following three Objectives:

Primary Objective 1:

Primary Objective 2:

Primary Objective 3:

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Personalized exercise group (INTGroup)	Other	Other: Exercise testing results, Other: 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)	Other	Other: Exercise testing results, Other: 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.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise testing resultsTailored, 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 group, Attention Control (AC Group), Personalized exercise group (INTGroup)
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	Personalized exercise group (INTGroup)
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.	Other	Generalized exercise group, Attention Control (AC Group)

Primary outcome

Exercise Capacity
Time frame: Baseline to Week 20
Changes in Peak VO2/2-minute step in place test in both INT and AC groups
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

8 secondary outcomes

Patient Health Questionnaire (PHQ-9)
Time frame: baseline, week 20, 6 months after week 20
Generalized Anxiety Disorder (GAD-7)
Time frame: 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
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: baseline, week 20, 6 months after week 20
Work and Social Adjustment Scale (WSAS)
Time frame: 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
Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ)
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Derived from this study: PubMed 37730199Maharaj A, Jefferies JL, Mulrooney DA, Armstrong GT, Brinkman TM, O'Neil ST, Terrell S, Partin RE, Srivastava DK, Hudson MM, Wang Z, Ness KK. Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Contemp Clin Trials. 2023 Oct;133:107339. doi: 10.1016/j.cct.2023.107339. Epub 2023 Sep 18.
St. Jude Children's Research HospitalLink provided by the sponsor.
Clinical Trials Open at St. JudeLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Childhood Cancer

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kirsten Ness, PhD principal investigator

St. Jude Children's Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Capacity (time frame: Baseline to Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04714840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.