NCT04714840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

March 10, 2020

Last Update Submit

March 31, 2026

Conditions

Childhood CancerMobility Limitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Patient Health Questionnaire (PHQ-9)

    baseline, week 20, 6 months after week 20

  • Generalized Anxiety Disorder (GAD-7)

    baseline, week 20, 6 months after week 20

  • PROMIS Ability to Participate 8a (SF v2.0)

    baseline, week 20, 6 months after week 20

  • Work Productivity and Activity Impairment Questionnaire (WPAI)

    baseline, week 20, 6 months after week 20

  • Work and Social Adjustment Scale (WSAS)

    baseline, week 20, 6 months after week 20

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: Exercise testing resultsOther: 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.

Other: Exercise testing resultsOther: Generalized exercise recommendations (AC)

Interventions

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.

Generalized exercise group, Attention Control (AC Group)Personalized exercise group (INTGroup)
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.

Personalized exercise group (INTGroup)
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.

Generalized exercise group, Attention Control (AC Group)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • 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.

    PMID: 37730199DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsMobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kirsten Ness, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

January 19, 2021

Study Start

February 8, 2021

Primary Completion

September 15, 2025

Study Completion

February 23, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available at the time of article publication.
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.

Locations

US(1)