Clinical trial NCT05205512: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Adherence to the telehealth exercise intervention
timeFrame: Up to 2 years
Secondary outcomes:
measure: Effects of an 8-week telehealth exercise intervention
timeFrame: At baseline up to week 9
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kyuwan Lee
role: PRINCIPAL_INVESTIGATOR
References: