Lifestyle Intervention for Veterans With Blood Cancer: Tele-Intervention

NCT07058571 | Recruiting

• 1 other identifier: 1823598
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Physical Activity; Exercise; Tele-oncology; Blood Cancer

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline

• Demographics Form

  Baseline

• 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.

  Baseline and 12 weeks follow-up

• 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.

  Baseline and 12 weeks follow-up

• Four-Item Patient Health Questionnaire for Anxiety and Depression

  A 4-item, self-report measure assessing the frequency of mental health symptoms across a 2-week period.

  Baseline and 12 weeks follow-up

• Numeric Pain Rating Scale and McGill Pain Questionnaire Short-Form

  A 15 item, self-report measure asking about the location and type of an individuals current pain level.

  Baseline and 12 weeks follow-up

• PROMIS-Physical Function Cancer Item Bank

  A 45 item, self-report measure of physical function, with responses ranging from 1 (Unable to do) to 5 (Without any difficulty).

  Baseline and 12 weeks follow-up

Secondary Outcomes (1)

• Technology Acceptance Model surveys

  12 weeks follow-up (Post-Intervention)

Study Arms (1)

Intervention Group

EXPERIMENTAL

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).

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

Related Publications (3)

• Mounier NM, Abdel-Maged AE, Wahdan SA, Gad AM, Azab SS. Chemotherapy-induced cognitive impairment (CICI): An overview of etiology and pathogenesis. Life Sci. 2020 Oct 1;258:118071. doi: 10.1016/j.lfs.2020.118071. Epub 2020 Jul 14.

  PMID: 32673664 BACKGROUND

• Jiang CY, El-Kouri NT, Elliot D, Shields J, Caram MEV, Frankel TL, Ramnath N, Passero VA. Telehealth for Cancer Care in Veterans: Opportunities and Challenges Revealed by COVID. JCO Oncol Pract. 2021 Jan;17(1):22-29. doi: 10.1200/OP.20.00520. Epub 2020 Sep 24.

  PMID: 32970512 BACKGROUND

• Rapid Growth in Telehealth for Cancer Care - NCI. Published March 9, 2022. Accessed May 31, 2023. https://www.cancer.gov/news-events/cancer-currents-blog/2022/pandemic-telehealth-surge-cancer-care

  BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Motor Activity

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Julie Faieta

CONTACT

84128221682; Julie.Faieta@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 10, 2025
• Study Start: April 3, 2015
• Primary Completion: January 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)