LymphomaNCT07014293
Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
A study testing SMART3RP-Lymphoma in people with Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- SMART3RP-Lymphoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to 1 Jul 2030
- 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
- English speaking adult (18 years or older at enrollment)
- Is at least 6 months post-diagnosis and a) is currently undergoing lymphoma treatment (includes surgery, chemotherapy/immunotherapy/radiation therapy, or other) with evidence of treatment response or disease control; or b) has completed lymphoma treatment (e.g., chemotherapy/immunotherapy/radiation therapy, surgery or other) within the past 2 years and has disease control at treatment completion; patients may still be on maintenance treatment to prolong disease control.
Who cannot join
- Has not initiated treatment for lymphoma.
- Has worsening, progressive, or uncontrolled disease that is not responding to treatment.
- Active Psychiatric, medical or cognitive comorbidity as determined by site PI or treating clinician
- Unwilling or unable to participate using telehealth platform
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
Mass General Brigham
Boston, Massachusetts, 02114
Giselle Perez, PhD, 617-724-0765, gperez@mgh.harvard.edu
Giselle Perez, PhD
About this study
The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.
Read the detailed description
This is a randomized controlled trial assessing the effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency-Lymphoma (SMART3RP-Lymphoma) compared to Enhanced Usual Care on 254 early post treatment lymphoma survivors. The SMART-3RP is a comprehensive, evidence-based mind body group program designed to help individuals adapt to chronic stress (i.e., increase their resilience). It understands the adjustment to chronic stress as a dynamic process, blending CBT, positive psychology and mind body tools to target key coping processes.
This trial seeks to answer the following questions:
- Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?
- Do factors, such as age, sex, race/ethnicity, rural/urban living, socioeconomic status, impact how survivors respond to the treatment?
Of note: This record describes our primary aim to compare the effects of SMART3RP-Lymphoma to enhanced usual care on lymphoma survivors' coping with the adjustment to posttreatment survivorship. While this trial will explore potential sociodemographic moderators of the main intervention effects on our primary aim (Aim 1), given the exploratory nature of these analyses (i.e., hypothesis-generating), we will not report the results of our moderation analyses in this record but rather focus on the main effects of the study intervention.
- Conditions
- Lymphoma
- Being tested
- Enhanced Usual Care, SMART3RP-Lymphoma
- Keywords
- coping, psychosocial intervention, survivorship, resilience
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareOther
Participants will receive a singleevaluation with a site social worker along with a list of mental health, social or community resources . This most closely resembles the real-world care available to survivors on an outpatient basis, however, we call this enhanced usual care since proactive identification and referral of posttreatment survivors is not routinely done.
SMART3RP-LymphomaOther
The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Other | Participants randomized to EUC will be referred to their site social work team. This most closely resembles the real-world care available to survivors on an outpatient basis. It is an enhanced version of usual care because proactive identification and referral of posttreatment survivors is not routinely done. Receives: Other: Enhanced Usual Care |
| SMART3RP-Lymphoma | Experimental | Participants will participate in 8 weekly group sessions, delivered virtually. The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion. Receives: Other: SMART3RP-Lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
The Measure of Current Status Scale (MOCS-A) measures coping processes on 4 domains: ability to relax, recognize stress, elicit support, and restructure thoughts. It is a 13-item scale where each item is measured on a 0-4 scale.
Measured: Baseline to 3 month follow up
Secondary outcomes (6)
Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)
The Generalized Anxiety Disorder Scale-7 (GAD-7) is a 7-item self-report measure assessing symptoms of anxiety. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.
Measured: Enrollment to 3 month follow up
Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing symptoms of depression. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 24. Higher scores indicate greater depressive symptom severity.
Measured: Enrollment to 3 month follow up
Change in Physical Health (PROMIS Physical Function-8b)
The PROMIS Physical Function-8b is an 8-item measure that assesses the ability to perform daily living activities. Each item is scored on a scale of 1 (Unable to do) to 5 (Without any difficulty).
Measured: Enrollment to 3 month follow up
Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)
The Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item self-report measure assessing overall quality of life across four domains: physical well-being, functional well-being, emotional well-being, and social/family well-being. Items are rated on a 0 (not at all) to 4 (very much) scale and summed to produce a total score ranging from 0 to 108. Higher scores indicate better quality of life.
Measured: Enrollment to 3 month follow up
Change in Quality of Life Based on the PROMIS Global-10
The PROMIS Global-10 is a 10-item measure assessing overall quality of life. Responses are converted to standardized T-scores (mean = 50, standard deviation = 10), with possible scores ranging approximately from 0 to 100. Higher T-scores indicate better overall quality of life.
Measured: Enrollment to 3 month follow up
Change in Resilience scores (Current Experiences Scale (CES-23))
The CES-23 is a 23-item measure that assesses resilience on 6 dimensions: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. Each item is scored on a 0 (not at all) to 5 (to a very great degree) scale.
Measured: Enrollment to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start3 Sep 2026
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (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 Massachusetts General HospitalThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle K. Perez Lougee, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014293
- Sponsor's protocol ID
- 25-161
- Other IDs
- RSGHE-24-1325325-01-CTPS
- Status last verified
- Sep 2026
- First submitted
- 23 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT07014293
- Acronym / sponsor ID
- 25-161
- Conditions
- Lymphoma
- Keywords
- coping, psychosocial intervention, survivorship, resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 10 Jun 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.
The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.
Detailed description
This is a randomized controlled trial assessing the effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency-Lymphoma (SMART3RP-Lymphoma) compared to Enhanced Usual Care on 254 early post treatment lymphoma survivors. The SMART-3RP is a comprehensive, evidence-based mind body group program designed to help individuals adapt to chronic stress (i.e., increase their resilience). It understands the adjustment to chronic stress as a dynamic process, blending CBT, positive psychology and mind body tools to target key coping processes.
This trial seeks to answer the following questions:
- Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?
- Do factors, such as age, sex, race/ethnicity, rural/urban living, socioeconomic status, impact how survivors respond to the treatment?
Of note: This record describes our primary aim to compare the effects of SMART3RP-Lymphoma to enhanced usual care on lymphoma survivors' coping with the adjustment to posttreatment survivorship. While this trial will explore potential sociodemographic moderators of the main intervention effects on our primary aim (Aim 1), given the exploratory nature of these analyses (i.e., hypothesis-generating), we will not report the results of our moderation analyses in this record but rather focus on the main effects of the study intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Other | Other: Enhanced Usual CareParticipants randomized to EUC will be referred to their site social work team. This most closely resembles the real-world care available to survivors on an outpatient basis. It is an enhanced version of usual care because proactive identification and referral of posttreatment survivors is not routinely done. |
| SMART3RP-Lymphoma | Experimental | Other: SMART3RP-LymphomaParticipants will participate in 8 weekly group sessions, delivered virtually. The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking adult (18 years or older at enrollment)
- Is at least 6 months post-diagnosis and a) is currently undergoing lymphoma treatment (includes surgery, chemotherapy/immunotherapy/radiation therapy, or other) with evidence of treatment response or disease control; or b) has completed lymphoma treatment (e.g., chemotherapy/immunotherapy/radiation therapy, surgery or other) within the past 2 years and has disease control at treatment completion; patients may still be on maintenance treatment to prolong disease control.
Key exclusion criteria (4 listed)
- Has not initiated treatment for lymphoma.
- Has worsening, progressive, or uncontrolled disease that is not responding to treatment.
- Active Psychiatric, medical or cognitive comorbidity as determined by site PI or treating clinician
- Unwilling or unable to participate using telehealth platform
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 |
|---|---|---|
| Enhanced Usual CareParticipants will receive a singleevaluation with a site social worker along with a list of mental health, social or community resources . This most closely resembles the real-world care available to survivors on an outpatient basis, however, we call this enhanced usual care since proactive identification and referral of posttreatment survivors is not routinely done. | Other | Enhanced Usual Care |
| SMART3RP-LymphomaThe intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion. | Other | SMART3RP-Lymphoma |
Primary outcome
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
Time frame: Baseline to 3 month follow up
The Measure of Current Status Scale (MOCS-A) measures coping processes on 4 domains: ability to relax, recognize stress, elicit support, and restructure thoughts. It is a 13-item scale where each item is measured on a 0-4 scale.
6 secondary outcomes
Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: Enrollment to 3 month follow up
Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)
Time frame: Enrollment to 3 month follow up
Change in Physical Health (PROMIS Physical Function-8b)
Time frame: Enrollment to 3 month follow up
Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Enrollment to 3 month follow up
Change in Quality of Life Based on the PROMIS Global-10
Time frame: Enrollment to 3 month follow up
Change in Resilience scores (Current Experiences Scale (CES-23))
Time frame: Enrollment to 3 month follow up
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART3RP-Lymphoma in people with Lymphoma, run by Massachusetts General Hospital 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 28 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A) (time frame: Baseline to 3 month follow up). 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 28 Sep 2026.