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Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3RP-Lymphoma
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring Lymphoma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3RP-Lymphoma

Arm Description

-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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 21, 2017
Last Updated
November 9, 2021
Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03212261
Brief Title
Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
Official Title
Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3RP-Lymphoma
Arm Type
Experimental
Arm Description
-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.
Intervention Type
Behavioral
Intervention Name(s)
3RP-Lymphoma
Other Intervention Name(s)
Relaxation Response Resiliency Program for Lymphoma
Intervention Description
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Primary Outcome Measure Information:
Title
Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions
Description
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.
Time Frame
1 month after completing the 3RP-Lymphoma program
Title
Number of Participants Who Found the 3RP Program Acceptable
Description
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.
Time Frame
1 month after completing the 3RP-Lymphoma program
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples
Description
The investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.
Time Frame
1 month after completing the 3RP-Lymphoma program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giselle K. Perez, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

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