- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205512
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.
SECONDARY OBJECTIVE:
I. Explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (TELEHEALTH EXERCISE): Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
GROUP II (DELAYED CONTROL): Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
After completion of study treatment, participants are followed up after 1 week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with Hodgkin or non-Hodgkin lymphoma.
- >= 18 years old.
- Are between 2-5 years after completing anti-cancer therapy and with no evidence of disease.
- Intermediate (4-5) to high ( >= 6) risk of cardiovascular risk factors based on six key variables: Age 30 to 50 years (y) [2]) and >= 50y [3]; anthracycline dose >250mg/m ^ 2 [1]; hypertension [2]; diabetes [2]; smoking [1]; and chest radiation [1]).
- Able to understand and sign the informed consent document.
- Physically able and willing to complete all study procedures.
Exclusion Criteria:
- Have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina).
- Have contraindications to exercise.
- Participate in structured exercise (>60 minutes/week).
- Female patients who are pregnant or planning to become pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (telehealth exercise)
Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
|
Ancillary studies
Participate in telehealth exercise intervention
Other Names:
|
|
Active Comparator: Group II (delayed control)
Patients maintain current levels of physical activity for 8 weeks.
Patients may then participate in telehealth exercise intervention for 8 weeks.
|
Ancillary studies
Participate in telehealth exercise intervention
Other Names:
Maintain current levels of physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to the telehealth exercise intervention
Time Frame: Up to 2 years
|
Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of an 8-week telehealth exercise intervention
Time Frame: At baseline up to week 9
|
The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.
|
At baseline up to week 9
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyuwan Lee, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma
- Hemic and Lymphatic Diseases
- Lymphoma, Non-Hodgkin
- Hodgkin Disease
- Health Services Administration
- Delivery of Health Care
- Patient Care Management
- Telemedicine
Other Study ID Numbers
- 21595 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2021-13305 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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