Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
Primary Purpose
Hodgkin Lymphoma, Non-Hodgkin Lymphoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Questionnaire Administration
Telemedicine
Sponsored by
About this trial
This is an interventional supportive care trial for Hodgkin Lymphoma
Eligibility Criteria
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.
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (telehealth exercise)
Group II (delayed control)
Arm Description
Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
Outcomes
Primary Outcome Measures
Adherence to the telehealth exercise intervention
Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).
Secondary Outcome Measures
Effects of an 8-week telehealth exercise intervention
The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.
Full Information
NCT ID
NCT05205512
First Posted
December 27, 2021
Last Updated
September 20, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05205512
Brief Title
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
Official Title
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (telehealth exercise)
Arm Type
Experimental
Arm Description
Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
Arm Title
Group II (delayed control)
Arm Type
Active Comparator
Arm Description
Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Maintain current levels of physical activity
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Telemedicine
Other Intervention Name(s)
Telehealth
Intervention Description
Participate in telehealth exercise intervention
Primary Outcome Measure Information:
Title
Adherence to the telehealth exercise intervention
Description
Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Effects of an 8-week telehealth exercise intervention
Description
The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.
Time Frame
At baseline up to week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuwan Lee
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
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