Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study

Conditions
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Hodgkin Lymphoma, Non-Hodgkin Lymphoma

Intervention / Treatment
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* Other: Exercise Intervention
* Other: Questionnaire Administration
* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (telehealth exercise)<br>Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks. | Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Telemedicine<br>* Participate in telehealth exercise intervention<br>* Other names: Telehealth;|
| Active Comparator: Group II (delayed control)<br>Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks. | Other: Exercise Intervention<br>* Maintain current levels of physical activity<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Telemedicine<br>* Participate in telehealth exercise intervention<br>* Other names: Telehealth;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline up to week 9 |