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

City of Hope

Status: Completed

Conditions: Hodgkin Lymphoma; Non-Hodgkin Lymphoma

Treatments: Other: Exercise Intervention; Other: Questionnaire Administration; Other: Telemedicine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05205512

P30CA033572 (U.S. NIH Grant/Contract)

21595 (Other Identifier)

NCI-2021-13305 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Group I (telehealth exercise)

Experimental group

Description:

Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.

Treatment:

Other: Telemedicine

Other: Questionnaire Administration

Group II (delayed control)

Active Comparator group

Description:

Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.

Treatment:

Other: Telemedicine

Other: Questionnaire Administration

Other: Exercise Intervention