Recruiting

Telehealth Intervention

Sponsor:

VA Pittsburgh Healthcare System

Code:

NCT07058571

Conditions

Blood Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study Details

Brief summary:

Background. This study aims to evaluate the effectiveness of a telehealth-mediated lifestyle intervention program tailored for veterans with blood cancer, focusing on improving health-related quality of life, mental health, and pain outcomes. The hypothesis posits that the telehealth-delivered program will lead to significant improvements in these areas, specifically targeting veterans undergoing treatment or in post-treatment phases.

Objective. Recognizing the unique experiences of veterans, especially those in rural or underserved regions, this study seeks to provide insights into the feasibility and impact of telehealth-based lifestyle interventions for this distinct population.

Methods. The pilot trial will enroll 30 veterans from the H. John Heinz III VA. Participants will complete baseline web-based surveys assessing demographics, occupational performance, and telehealth preparedness. The intervention comprises progressive resistance and aerobic exercises delivered via telehealth by a health coach, starting with a live supervised session followed by regular remote sessions. Each participant will engage in exercise sessions coordinated through the Veteran's Video Connect (VVC) application, with ongoing communication facilitated via email. This setup allows the health coach to adjust exercise intensity based on real-time symptom feedback.

To address potential technology literacy biases, the VVCMatch assessment will categorize veterans as "technology prepared" or in need of additional education. Those requiring support will receive guidance on using the VVC app before starting the intervention. Additionally, participants will receive dietary consultations from the Leukemia and Lymphoma Society, independent of the research team.

Outcome measures include assessments of symptoms, fatigue, function, mental health, and pain, along with evaluations of the intervention's usability through surveys on perceived usefulness and ease of use. These assessments aim to detect meaningful changes and ensure the intervention's effectiveness and acceptability among veterans.

Conditions

Blood Cancers

Study ID

NCT07058571

Start date

Apr 3, 2015

Status verified date

Jun, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Living with blood cancer
  • Physically willing and able to perform 30-90 minutes of exercise a minimum of 2 times per week

Exclusion Criteria:

  • Veterans who are unable to perform 30-90 minutes of exercise twice a week
  • Veterans with significant disabilities related to balance or motion that would cause a safety risk
  • Veterans without a smart personal device (smart phone, tablet, or computer) and internet connection (for example, cellular or WIFI connection)
  • Veterans who are pregnant

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

All veterans in the intervention group (e.g., total N) will engage in 12 week telehealth mediated exercise intervention. Veterans will also have the opportunity to undergo a centralized dietary consultation and recommendations (by a Leukemia and Lymphoma Society (LLS) member).

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Participating Veterans will engage in bi-weekly, telehealth mediated resistance exercise session. Aerobic exercise will be monitored passively through FitBit data collection. Telehealth exercise sessions will last approximately 45-90 minutes pending the individual Veteran's progress. Participants will also undergo a one-time dietary consultation and recommendations by a Leukemia and Lymphoma Society (LLS) member.

Primary outcome measure

  • VVCMatch telehealth preparedness measure (5 Minute Montreal Cognitive Assessment component) [ Time Frame: Baseline ]
  • Demographics Form [ Time Frame: Baseline ]
  • Global Fatigue Index [ Time Frame: Baseline and 12 weeks follow-up ]
  • The Numeric Pain Rating Scale Instructions [ Time Frame: Baseline and 12 weeks follow-up ]
  • Four-Item Patient Health Questionnaire for Anxiety and Depression [ Time Frame: Baseline and 12 weeks follow-up ]
  • Numeric Pain Rating Scale and McGill Pain Questionnaire Short-Form [ Time Frame: Baseline and 12 weeks follow-up ]
  • PROMIS-Physical Function Cancer Item Bank [ Time Frame: Baseline and 12 weeks follow-up ]

Central Contacts and Locations

Central contacts

Julie Faieta

84128221682Julie.Faieta@va.gov

Locations

VA Pittsburgh Healthcare System

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Julie Faieta

412-822-1682julie.faieta@va.gov

Principal Investigator:

Julie Faieta

More Information

Sponsor

VA Pittsburgh Healthcare System

Last update posted

Jul 10, 2025

Last verified

Jun, 2025

Keywords

  • Physical Activity
  • Exercise
  • Tele-oncology
  • Blood Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Pittsburgh Healthcare System on 2025-07-10.