Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

A study testing 3RP-Lymphoma in people with Lymphoma, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Relaxation Response Resiliency Program (3RP) was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine; This program has recently been adapted to target the needs of individuals who have completed treatment for lymphoma (3RP-Lymphoma). Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Lymphoma
What is being tested?: 3RP-Lymphoma
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2017to 24 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Aged 18-64
Within 2 years post-treatment completion for lymphoma
English speaking
Able and willing to provide informed consent
Cancer treatment or follow-up for lymphoma at the MGH Cancer Center

Who cannot join

Unwilling or unable to participate in the study
Unable to speak or read English
Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI)
Unwilling or unable to participate in group 3RP sessions delivered via the Partners Telehealth videoconferencing software
Participation in qualitative interview during Phase 1 (DF/HCC 16-396)

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the detailed description

The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP 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.

The 3RP has not yet been carried out with individuals who have recently completed treatment for lymphoma. As such, the investigators have adapted the standard 3RP program to target the specific needs of lymphoma patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-Lymphoma, is effective at reducing stress and stress-related symptoms for people who have completed treatment for lymphoma within the past two years. To develop the 3RP-Lymphoma, the investigators conducted interviews with patients who had recently completed treatment to learn about their experiences and their preferences for topics they would want to include in a program tailored to their specific needs. The current phase of the feasibility study will examine if the adapted program is feasible, acceptable, and helps promote stress management among lymphoma survivors who are in the early stages of completing cancer treatment.

Conditions: Lymphoma
Being tested: 3RP-Lymphoma
Keywords: Lymphoma
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3RP-LymphomaBehavioural
Also called Relaxation Response Resiliency Program for Lymphoma
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.

Study groups in NCT03212261
Study group	Role	What they receive
3RP-Lymphoma	Experimental	-An adapted version of the 3RP (3RP-Lymphoma) for lymphoma survivors recently completing cancer treatment. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. It will be delivered in weekly sessions over the course of approximately 8 weeks. Receives: Behavioral: 3RP-Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions
The investigators will evaluate program feasibility by examining rates of treatment completion. Participants who complete at least 75% of the treatment sessions will be identified as treatment completers.
Measured: 1 month after completing the 3RP-Lymphoma program
Number of Participants Who Found the 3RP Program Acceptable
Acceptability will be assessed at the one-month follow up data collection period with five questions on the 3RP acceptability questionnaire rated on a 4-point Likert scale (1=not at all to 4=very much); higher scores mean higher levels of acceptability.
Measured: 1 month after completing the 3RP-Lymphoma program

Secondary outcomes (1)

Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples
The investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.
Measured: 1 month after completing the 3RP-Lymphoma program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 201724 Sep 2018

First posted11 Jul 2017
Study start3 Aug 2017
Primary completion30 Jun 2018
Study completion24 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03212261
Sponsor's protocol ID: 17-063
Status last verified: Nov 2021
First submitted: 21 Jun 2017
Last updated: 10 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
ClinicalTrials.gov ID: NCT03212261
Acronym / sponsor ID: 17-063
Conditions: Lymphoma
Keywords: Lymphoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: 3 Aug 2017 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 24 Sep 2018 (actual)
First posted: 11 Jul 2017 (actual)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3RP-Lymphoma	Experimental	Behavioral: 3RP-Lymphoma-An adapted version of the 3RP (3RP-Lymphoma) for lymphoma survivors recently completing cancer treatment. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. It will be delivered in weekly sessions over the course of approximately 8 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Aged 18-64
Within 2 years post-treatment completion for lymphoma
English speaking
Able and willing to provide informed consent
Cancer treatment or follow-up for lymphoma at the MGH Cancer Center

Key exclusion criteria (5 listed)

Unwilling or unable to participate in the study
Unable to speak or read English
Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI)
Unwilling or unable to participate in group 3RP sessions delivered via the Partners Telehealth videoconferencing software
Participation in qualitative interview during Phase 1 (DF/HCC 16-396)

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
3RP-LymphomaAlso: Relaxation Response Resiliency Program for LymphomaAn adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.	Behavioural	3RP-Lymphoma

Primary outcome

Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions
Time frame: 1 month after completing the 3RP-Lymphoma program
The investigators will evaluate program feasibility by examining rates of treatment completion. Participants who complete at least 75% of the treatment sessions will be identified as treatment completers.
Number of Participants Who Found the 3RP Program Acceptable
Time frame: 1 month after completing the 3RP-Lymphoma program
Acceptability will be assessed at the one-month follow up data collection period with five questions on the 3RP acceptability questionnaire rated on a 4-point Likert scale (1=not at all to 4=very much); higher scores mean higher levels of acceptability.

1 secondary outcome

Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples
Time frame: 1 month after completing the 3RP-Lymphoma program

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3RP-Lymphoma	37	21

Primary outcome: Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions

Time frame: 1 month after completing the 3RP-Lymphoma program. Count of participants. Unit: Participants

Measure	3RP-Lymphoma n = 26
Value	20

Population analysed: These are people who enrolled and completed at least one 3RP-lymphoma session. This will serve as our denominator to examine the number of people who complete at least 75% of treatment sessions.

Primary outcome: Number of Participants Who Found the 3RP Program Acceptable

Time frame: 1 month after completing the 3RP-Lymphoma program. Count of participants. Unit: Participants

Measure	3RP-Lymphoma n = 21
Enjoyable: Somewhat/Very	21
Enjoyable: Not at all/Not very	0
Helpful: Somewhat/Very	21
Helpful: Not at all/Not very	0
Relevant: Somewhat/Very	21
Relevant: Not at all/Not very	0
Convenient: Somewhat/Very	19
Convenient: Not at all/Not very	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from all participants who initiated treatment (N=26). Adverse events were monitored throughout the duration of the intervention, which was approximately 8 weeks for every participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3RP-Lymphoma	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lymphoma

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

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. This study is not recruiting at the moment.

Giselle K. Perez, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 3RP-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 5 inclusion and 5 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: finished, as of the sponsor's last update on 10 Nov 2021. 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?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions (time frame: 1 month after completing the 3RP-Lymphoma program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03212261.

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 10 Nov 2021.