LymphomaNCT06923397
Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
A study testing Interrupted Sedentary Time Intervention in people with Lymphoma and Lymphoma, Hodgkin, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin
- What is being tested?
- Interrupted Sedentary Time Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 31 Dec 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
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, MD, PhD, 617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina Dieli-Conwright, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Lymphoma, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Sedentary Behavior
- Being tested
- Interrupted Sedentary Time Intervention
- Keywords
- Lymphoma, Hodgkin Lymphoma, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Non-Hodgkin Lymphoma, Sedentary Behavior
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted Sedentary Time InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Refusal Rate
Defined as ≤50% of eligible screened participants refuse to complete intervention.
Measured: 12 weeks
Retention Rate
Retention of consented participants to study end is ≥70%.
Measured: 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.
Measured: 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."
Measured: 13 weeks
Secondary outcomes (2)
Participant Glucose Level
Glucose levels will be assessed by constant glucose monitoring where an average of >180 mg/dl will be considered hyperglycemic.
Measured: Assessed for one week at each timepoint (baseline & post-intervention).
Participant Insulin Resistance
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.
Measured: Assessed for one week at each timepoint (baseline & post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start5 Jun 2025
- Primary completion28 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923397
- Sponsor's protocol ID
- 24-765
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
- ClinicalTrials.gov ID
- NCT06923397
- Acronym / sponsor ID
- 24-765
- Conditions
- Lymphoma, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Sedentary Behavior
- Keywords
- Lymphoma, Hodgkin Lymphoma, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Non-Hodgkin Lymphoma, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted Sedentary Time Intervention | Experimental | Behavioral: Interrupted Sedentary Time InterventionThe 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interrupted Sedentary Time InterventionA 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. | Behavioural | Interrupted Sedentary Time Intervention |
Primary outcome
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).
Refusal Rate
Time frame: 12 weeks
Defined as ≤50% of eligible screened participants refuse to complete intervention.
Retention Rate
Time frame: 13 weeks
Retention of consented participants to study end is ≥70%.
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.
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."
2 secondary outcomes
Participant Glucose Level
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, MD, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted Sedentary Time Intervention in people with Lymphoma and Lymphoma, Hodgkin, run by Dana-Farber Cancer Institute 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 9 inclusion and 6 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 13 Apr 2026. 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 Christina Dieli-Conwright, MD, PhD (617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Completion Rate (Feasibility) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.