NCT07058571 · VA Pittsburgh Healthcare System
Lifestyle Intervention for Veterans With Blood Cancer: Tele-Intervention
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
VVCMatch telehealth preparedness measure (5 Minute Montreal Cognitive Assessment component)
Time frame: Baseline
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.
Demographics Form
Time frame: Baseline
Global Fatigue Index
Time frame: Baseline and 12 weeks follow-up
A 15 item self-report assessment to gauge the impact that fatigue has has on and individual's day-to-day life.
The Numeric Pain Rating Scale Instructions
Time frame: Baseline and 12 weeks follow-up
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.
Four-Item Patient Health Questionnaire for Anxiety and Depression
Time frame: Baseline and 12 weeks follow-up
A 4-item, self-report measure assessing the frequency of mental health symptoms across a 2-week period.
Numeric Pain Rating Scale and McGill Pain Questionnaire Short-Form
Time frame: Baseline and 12 weeks follow-up
A 15 item, self-report measure asking about the location and type of an individuals current pain level.
PROMIS-Physical Function Cancer Item Bank
Time frame: Baseline and 12 weeks follow-up
A 45 item, self-report measure of physical function, with responses ranging from 1 (Unable to do) to 5 (Without any difficulty).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburgh, Pennsylvania
Collaborators
The Leukemia and Lymphoma Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2025 · Source of record for eligibility and locations