Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

November 9, 2021 updated by: Giselle K. Perez Lougee, Massachusetts General Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Other Names:
  • Relaxation Response Resiliency Program for Lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after completing the 3RP-Lymphoma program
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 month after completing the 3RP-Lymphoma program

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2017

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

September 24, 2018

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (ACTUAL)

July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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