Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
NCT ID: NCT06923397
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-06-05
2026-12-31
Brief Summary
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Detailed Description
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Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires.
Participation in this research study is expected to last about 3 months.
It is expected that about 24 people will take part in this research study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interrupted Sedentary Time Intervention
The first 3 participants enrolled with be placed into the intervention group. After this, participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 14 participants will complete:
* Baseline visit
* Standard of care chemotherapy treatment regimen
* Daily exercise sessions in-clinic up to 4x weekly and at home 6 days per week
* Week 14 post-intervention visit
Interrupted Sedentary Time Intervention
A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.
Usual Care Control Group
Participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 7 participants will complete:
* Baseline visit
* Standard of Care chemotherapy treatment regimen
* Week 14 visit
* Participants will be offered Fitbit activity tracker and resistance bands at the end of the study.
No interventions assigned to this group
Interventions
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Interrupted Sedentary Time Intervention
A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with lymphoma.
* Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis.
* Aged ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included.
* Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise.
* Have physician clearance to participate in exercise.
* Speak English.
* Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
* Access to a phone that can receive text messages.
Exclusion Criteria
* Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention.
* Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects.
* Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
* Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christina Dieli-Conwright, PhD
Principal Investigator
Principal Investigators
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Christina Dieli-Conwright, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-765
Identifier Type: -
Identifier Source: org_study_id