LymphomaNCT07013435
A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship
A study testing Health Education Program and SMART3RP-Lymphoma in people with Lymphoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Health Education Program and SMART3RP-Lymphoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Oct 2026to Aug 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 or Spanish speaking adults (18+ at time of enrollment)
- Within 1-5 years of completing active treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other); individuals may be on maintenance treatment.
Who cannot join
- Active psychiatric, medical concern or cognitive comorbidity as determined by the site PI or treating clinician
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
Giselle K Perez, PhD, 617-724-0765, gperez@mgh.harvard.edu
Giselle K Perez, PhD
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Frank Penedo, PhD, 305-284-4290, frank.penedo@miami.edu
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Anne Kirchhoff, PhD, 801-587-4084, Anne.Kirchhoff@hci.utah.edu
Anne Kirchhoff, PhD
About this study
Official title: Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.
The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.
Read the detailed description
The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.
The main questions it aims to answer are:
- Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?
- Will improvements in resiliency lead to improvements in quality of life?
To answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.
Participants will:
- Fill out 4 surveys across 12 months
- Participate in 8 weekly, virtual group sessions
- Submit hair cortisol samples
- Conditions
- Lymphoma
- Being tested
- Health Education Program, SMART3RP-Lymphoma
- Keywords
- quality of life, psychosocial intervention, supportive care, cancer 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.
Health Education ProgramOther
8 weekly sessions that include education on the co-occurrence of mental and physical problems, goal setting for health behavior change, and self-monitoring. Each session includes basic didactic information, interactive application of the information, and open discussion of didactic material.
SMART3RP-LymphomaOther
The SMART3RP-lymphoma is a group program that, through a variety of mind-body approaches, such as imagery, relaxation, and yoga, seeks to buffer stress and promote psychological resiliency and physical well-being.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Program | Active comparator | Participants will participate in 8 weekly sessions.
Components include:
* education on the co-occurrence of mental and physical problems
* goal setting for health behavior change
* self-monitoring
HEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP Receives: Other: Health Education Program |
| SMART3RP-Lymphoma | Experimental | Participants will participate in 8 weekly sessions.
The intervention components include:
* Eliciting the relaxation response (RR),
* CBT strategies to improve stress management
* Positive psychology strategies to achieve growth enhancement Receives: Other: SMART3RP-Lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL): Change in PROMIS-29
To examine the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) in improving quality of life in early posttreatment lymphoma survivors. Quality of life will be measured using the PROMIS-29 which assesses physical, functional, emotional, and social quality of life. Each survey item is measured on a 1-5 scale. The unit of measurement is a score on a scale.
Measured: From enrollment to 6 month follow up
Secondary outcomes (1)
Resilience: Change in Scores on the Current Experiences Scale (CES)
To compare the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) on resilience in posttreatment lymphoma survivors. Resilience will be measured by the Current Experiences Scale (CES). The CES is a 23-item measure that assesses the following domains of resilience on 0-5 scale: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. The unit of measurement is a score on a 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 start6 Oct 2026
- Primary completionSep 2029 (estimated)
- Study completionAug 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
- NCT07013435
- Sponsor's protocol ID
- 25-204
- Status last verified
- Oct 2026
- First submitted
- 23 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified information as required by the NIH
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.
- ClinicalTrials.gov ID
- NCT07013435
- Acronym / sponsor ID
- 25-204
- Conditions
- Lymphoma
- Keywords
- quality of life, psychosocial intervention, supportive care, cancer survivorship, resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Aug 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 trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.
Detailed description
The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.
The main questions it aims to answer are:
- Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?
- Will improvements in resiliency lead to improvements in quality of life?
To answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.
Participants will:
- Fill out 4 surveys across 12 months
- Participate in 8 weekly, virtual group sessions
- Submit hair cortisol samples
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education Program | Active comparator | Other: Health Education ProgramParticipants will participate in 8 weekly sessions. Components include: * education on the co-occurrence of mental and physical problems * goal setting for health behavior change * self-monitoring HEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP |
| SMART3RP-Lymphoma | Experimental | Other: SMART3RP-LymphomaParticipants will participate in 8 weekly sessions. The intervention components include: * Eliciting the relaxation response (RR), * CBT strategies to improve stress management * Positive psychology strategies to achieve growth enhancement |
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 or Spanish speaking adults (18+ at time of enrollment)
- Within 1-5 years of completing active treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other); individuals may be on maintenance treatment.
Key exclusion criteria (1 listed)
- Active psychiatric, medical concern or cognitive comorbidity as determined by the site PI or treating clinician
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 |
|---|---|---|
| Health Education Program8 weekly sessions that include education on the co-occurrence of mental and physical problems, goal setting for health behavior change, and self-monitoring. Each session includes basic didactic information, interactive application of the information, and open discussion of didactic material. | Other | Health Education Program |
| SMART3RP-LymphomaThe SMART3RP-lymphoma is a group program that, through a variety of mind-body approaches, such as imagery, relaxation, and yoga, seeks to buffer stress and promote psychological resiliency and physical well-being. | Other | SMART3RP-Lymphoma |
Primary outcome
Quality of Life (QoL): Change in PROMIS-29
Time frame: From enrollment to 6 month follow up
To examine the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) in improving quality of life in early posttreatment lymphoma survivors. Quality of life will be measured using the PROMIS-29 which assesses physical, functional, emotional, and social quality of life. Each survey item is measured on a 1-5 scale. The unit of measurement is a score on a scale.
1 secondary outcome
Resilience: Change in Scores on the Current Experiences Scale (CES)
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. de-identified information as required by the NIH
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education Program and SMART3RP-Lymphoma in people with Lymphoma, run by Massachusetts General Hospital at 3 sites 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 1 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Quality of Life (QoL): Change in PROMIS-29 (time frame: From enrollment to 6 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.