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

Mobility Limitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714840
• Other study ID #: CARTOXIII
• Secondary ID: U01CA246570-01
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: St. Jude Children's Research Hospital
• Contact: Kirsten Ness, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer
• Mobility Limitation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	Changes in Peak VO2/2-minute step in place test in both INT and AC groups	Baseline to Week 20
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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