Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

April 9, 2026 updated by: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Christina Dieli-Conwright, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
  • 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:

  • Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
  • 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.
  • Patients currently taking weight loss drugs.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Completion Rate (Feasibility)
Time Frame: 12 weeks
Intervention feasibility is defined as: 1) A participant completes ≥70% of the supervised activity breaks on at least 3 out of the 4 infusion appointments. 2) A participant completes ≥70% of the prescribed home-based resistance activity breaks on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention). 3) A participant completes ≥70% of the prescribed home-based step goals (i.e., >250 steps per hour) on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention).
12 weeks
Refusal Rate
Time Frame: 12 weeks
Defined as ≤50% of eligible screened participants refuse to complete intervention.
12 weeks
Retention Rate
Time Frame: 13 weeks
Retention of consented participants to study end is ≥70%.
13 weeks
Acceptability of Intervention Measure (AIM) Scale
Time Frame: 13 weeks
Assessed by the Acceptability of the Intervention Measures, a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability. The intervention will be deemed acceptable by participants if ≥70% of participants have a mean score ≥ 4 on the AIM.
13 weeks
Acceptability Exit Survey
Time Frame: 13 weeks
The intervention will be deemed acceptable by participants if 1) ≥70% of participants report "agree" or "strongly agree" to the prompt "Participation in this study helped me reduce my daily sedentary time" and 2) ≥70% of participants report "probably" or "yes" to the prompt "I would recommend this program to other patients being treated for cancer."
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Glucose Level
Time Frame: Assessed for one week at each timepoint (baseline & post-intervention).
Glucose levels will be assessed by constant glucose monitoring where an average of >180 mg/dl will be considered hyperglycemic.
Assessed for one week at each timepoint (baseline & post-intervention).
Participant Insulin Resistance
Time Frame: Assessed for one week at each timepoint (baseline & post-intervention).
Insulin resistance will be assessed by calculating Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from fasting blood samples where values >1.9 will be considered insulin resistant.
Assessed for one week at each timepoint (baseline & post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Christina Dieli-Conwright, MD, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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