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Blood CancersNCT07058571

Lifestyle Intervention for Veterans With Blood Cancer: Tele-Intervention

A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Blood Cancers, run by VA Pittsburgh Healthcare System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blood Cancers
What is being tested?
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
3 Apr 2015to 31 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie Faieta contact

84128221682

Julie.Faieta@va.gov

United States1 site, 1 recruiting
  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

    Julie Faieta, 412-822-1682, julie.faieta@va.gov

    Julie Faieta

    Recruiting

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

Background. Since the changes in care delivery brought about by the COVID-19 pandemic, around 12% of outpatient cancer care visits are now conducted via telehealth. This approach, known as tele-oncology, offers cancer patients more efficient, convenient, and crucially, accessible care options. For VA populations, tele-oncology provides opportunities for follow-up post-diagnosis visits, visits while undergoing therapy (replacing in-person visits on chemotherapy days), and ongoing health surveillance. Variations in digital literacy among veterans can introduce bias in essential research on telehealth-delivered care interventions. To tackle this issue, our team has created and tested the VVCMatch, a tailored telehealth readiness tool. The VVCMatch is intended to proactively identify various barriers to tele-oncology that veterans may face, such as communication impairments and cognitive changes related to chemotherapy or hormonal therapy, including memory, mental flexibility, and processing challenges.

The proposed study aims to assess the efficacy of a telehealth-mediated lifestyle intervention program specifically designed for veterans with blood cancer. The primary focus is on evaluating improvements in health-related quality of life, mental health, and pain outcomes. This initiative acknowledges the unique experiences and challenges faced by veterans, who constitute a distinct population with specific needs, particularly those residing in rural or underserved areas. We hypothesize that the telehealth-delivered lifestyle intervention will result in significant enhancements in health-related quality of life, reduction in depressive symptoms, improved functional capacity, and decreased pain levels among the veteran participants. Such improvements are crucial for this demographic, as they often face barriers to accessing consistent, high-quality healthcare services.

Methods. This pilot trial will enroll 30 veterans from the H. John Heinz III VA, including those currently receiving treatment (such as chemotherapy or radiation therapy) and those in post-treatment stages. This inclusive approach is intended to increase recruitment feasibility and provide comprehensive insights across different treatment timelines. Baseline measurements will be collected through web-based surveys that evaluate demographics, occupational performance via the Canadian Occupational Performance Measure, and telehealth preparedness using the VVCMatch assessment.

The intervention itself is composed of two main components: progressive resistance and aerobic exercises. These will be delivered through a distance model facilitated by a health coach. The intervention begins with an initial supervised live exercise session conducted via telehealth, followed by regular remote sessions lasting 30 to 45 minutes each. These sessions are carried out via telehealth through the Veteran's Video Connect (VVC) application, with scheduling tailored to each participant's availability. Between sessions, communication is maintained through email, allowing for the exchange of information regarding session schedules and graphical progress reports.

A critical feature of this study is its adaptability to the participants' real-time needs. The health coach can modify exercise intensity based on daily symptom assessments, ensuring that each session is both effective and safe. This responsiveness is particularly important given the fluctuating nature of symptoms in individuals with blood cancer. To address potential disparities in technology literacy, the VVCMatch assessment will categorize participants into either a "technology prepared" or "technology education" group. Those identified as needing additional support will receive comprehensive telehealth education, including a walkthrough of the VVC application, to ensure they can fully engage with the intervention.

In addition to the physical activity component of exercise, participants will also have access to dietary consultations provided by the Leukemia and Lymphoma Society (LLS). This service underscores the holistic approach of the intervention, addressing both physical and dietary aspects of health.

Outcome measures include a range of assessments conducted at baseline and post-intervention. These encompass symptoms (using the VA Symptom Assessment Scale), fatigue (measured by the Global Fatigue Index), functional capacity (assessed via the PROMIS-Physical Function Cancer Item Bank), mental health (evaluated with the Four-Item Patient Health Questionnaire for Anxiety and Depression), and pain (measured using the Numeric Pain Rating Scale and the McGill Pain Questionnaire Short-Form). The intervention's usability will also be assessed using the Technology Acceptance Model, focusing on perceived usability, usefulness, and ease of use.

Overall, this study aims to provide valuable insights into the feasibility and impact of telehealth-based lifestyle interventions for veterans with blood cancer, potentially offering a scalable model to enhance the quality of life for this underserved population.

Conditions
Blood Cancers
Being tested
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Keywords
Physical Activity, Exercise, Tele-oncology, Blood Cancer
Medical subject headings
Hematologic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther

    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.

Study groups in NCT07058571
Study groupRoleWhat they receive
Intervention GroupExperimentalAll 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).
Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

  2. Demographics Form

    Measured: Baseline

  3. 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.

    Measured: Baseline and 12 weeks follow-up

  4. 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.

    Measured: Baseline and 12 weeks follow-up

  5. 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.

    Measured: Baseline and 12 weeks follow-up

  6. 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.

    Measured: Baseline and 12 weeks follow-up

  7. 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).

    Measured: Baseline and 12 weeks follow-up

Secondary outcomes (1)
  1. Technology Acceptance Model surveys

    Measured: 12 weeks follow-up (Post-Intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start3 Apr 2015
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058571
Sponsor's protocol ID
1823598
Status last verified
Jun 2025
First submitted
30 May 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32673664
  • 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.

    PubMed 32970512
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Blood Cancers, run by VA Pittsburgh Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie Faieta (84128221682, Julie.Faieta@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VVCMatch telehealth preparedness measure (5 Minute Montreal Cognitive Assessment component) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07058571, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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