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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05205512
Collaborator
National Cancer Institute (NCI) (NIH)
20
1
2
5.4
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise Intervention
  • Other: Questionnaire Administration
  • Other: Telemedicine
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.
SECONDARY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study
Anticipated Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Other: Questionnaire Administration
Ancillary studies

Other: Telemedicine
Participate in telehealth exercise intervention
Other Names:
  • Telehealth
  • 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.

    Other: Exercise Intervention
    Maintain current levels of physical activity

    Other: Questionnaire Administration
    Ancillary studies

    Other: Telemedicine
    Participate in telehealth exercise intervention
    Other Names:
  • Telehealth
  • Outcome Measures

    Primary Outcome Measures

    1. Adherence to the telehealth exercise intervention [Up to 2 years]

      Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).

    Secondary Outcome Measures

    1. Effects of an 8-week telehealth exercise intervention [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kyuwan Lee, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT05205512
    Other Study ID Numbers:
    • 21595
    • NCI-2021-13305
    • 21595
    • P30CA033572
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022