Lifestyle Intervention for Veterans With Blood Cancer: Tele-Intervention
ConditionBlood Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Pittsburgh Healthcare System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Living with blood cancer
Physically willing and able to perform 30-90 minutes of exercise a minimum of 2 times per week
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Other interventionParticipating 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
VVCMatch telehealth preparedness measure (5 Minute Montreal Cognitive Assessment component)
The Veteran's Video Connect (VVC)Match assesses Veteran's telehealth preparedness by considering their cognitive, physical, and digital literacy ability levels. The VVCMatch incorporates the 5-minute telephone Montreal Cognitive Assessment, followed by 28 self-report items.
Time frame
Baseline2
Demographics Form
Time frame
Baseline3
Global Fatigue Index
A 15 item self-report assessment to gauge the impact that fatigue has has on and individual's day-to-day life.
Time frame
Baseline and 12 weeks follow-up4
The Numeric Pain Rating Scale Instructions
An assessment that investigates the severity of an individual's current level of pain, and the lowest and highest level of pain they experienced in the past 24 hours.
Time frame
Baseline and 12 weeks follow-upSecondary outcomes
1
Technology Acceptance Model surveys
Time frame
12 weeks follow-up (Post-Intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Pittsburgh Healthcare System
Lead sponsor
The Leukemia and Lymphoma Society
Collaborator
Source ClinicalTrials.gov