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

NCT06923397 | Recruiting

• 1 other identifier: 24-765
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma; Lymphoma, Hodgkin; Lymphoma, Non-Hodgkin; Sedentary Behavior

Keywords

Lymphoma; Hodgkin Lymphoma; Lymphoma, Hodgkin; Lymphoma, Non-Hodgkin; Non-Hodgkin Lymphoma; Sedentary Behavior

Outcome Measures

Primary Outcomes (5)

• Intervention Completion Rate (Feasibility)

  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

  Defined as ≤50% of eligible screened participants refuse to complete intervention.

  12 weeks

• Retention Rate

  Retention of consented participants to study end is ≥70%.

  13 weeks

• Acceptability of Intervention Measure (AIM) Scale

  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

  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 Outcomes (2)

• Participant Glucose Level

  Assessed for one week at each timepoint (baseline & post-intervention).

• Participant Insulin Resistance

  Assessed for one week at each timepoint (baseline & post-intervention).

Study Arms (2)

Interrupted Sedentary Time Intervention

EXPERIMENTAL

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

Usual Care Control Group

NO INTERVENTION

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.

Interventions

Interrupted Sedentary Time Intervention BEHAVIORAL

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.

Interrupted Sedentary Time Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Sedentary Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Christina Dieli-Conwright, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, MD, PhD

CONTACT

617-582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)