Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03212261
• Collaborator: American Cancer Society, Inc. (Other)
• Enrollment: 37
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 2.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Behavioral: 3RP-Lymphoma	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
• Actual Study Start Date: Aug 3, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Sep 24, 2018

Arms and Interventions

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.	Behavioral: 3RP-Lymphoma; 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

Outcome Measures

Primary Outcome Measures

1. Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions [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.

2. Number of Participants Who Found the 3RP Program Acceptable [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.

Secondary Outcome Measures

1. Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• American Cancer Society, Inc.

Investigators

• Principal Investigator: Giselle K. Perez, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 14, 2018

More Information

Publications

None provided.

• Responsible Party: Giselle K. Perez Lougee, Instructor in Psychiatry at Harvard Medical School, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03212261
• Other Study ID Numbers: 17-063
• First Posted: Jul 11, 2017
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giselle K. Perez Lougee, Instructor in Psychiatry at Harvard Medical School, Massachusetts General Hospital: Lymphoma
• Additional relevant MeSH terms: Lymphoma

Study Results

Participant Flow

Recruitment Details	Screening and recruitment occurred from August through December 2017. There were a few subjects who expressed interest in discussing participation in January 2018 due to the holidays, which led to their enrollment in January 2018. However, the active recruitment period occurred from August through December 2017.
Pre-assignment Detail	Individuals who signed consent but who are found to be unable to use the videoconferencing software during the brief test call will be considered ineligible for the study. Two people fell into this category.

Arm/Group Title	3RP-Lymphoma
Arm/Group 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. 3RP-Lymphoma: An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Period Title: Overall Study
STARTED	37
Remained Eligible	35
Baseline Completion	30
Program Initiation	26
Post-intervention Survey	22
One Month Follow-up	21
COMPLETED	21
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	3RP-Lymphoma
Arm/Group Description	Individuals who initiated and participated in any 3RP-lymphoma session
Overall Participants	26
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.41 (12.15)
Sex: Female, Male (Count of Participants)
Female	14 53.8%
Male	12 46.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	26 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 92.3%
More than one race	1 3.8%
Unknown or Not Reported	1 3.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	3RP-Lymphoma
Arm/Group Description	Individuals who initiated and participated in any 3RP-lymphoma session
Measure Participants	26
Count of Participants [Participants]	20 76.9%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	3RP-Lymphoma
Arm/Group Description	Individuals who initiated and participated in any 3RP-lymphoma session and completed the 1 month follow up survey
Measure Participants	21
Somewhat/Very	21 80.8%
Not at all/Not very	0 0%
Somewhat/Very	21 80.8%
Not at all/Not very	0 0%
Somewhat/Very	21 80.8%
Not at all/Not very	0 0%
Somewhat/Very	19 73.1%
Not at all/Not very	2 7.7%
Somewhat/Very	21 80.8%
Not at all/Not very	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Of the 26 participants who participated in the program, only 20 patients were actually able to provide a hair sample. Reasons why they were no longer eligible were because they either had no hair (n=5), or because they reported taking a steroid at the time of collection (n=1).

Arm/Group Title	3RP-Lymphoma
Arm/Group Description	Individuals who initiated and participated in any 3RP-lymphoma session
Measure Participants	26
Total eligible to provide a sample	20 76.9%
Total provided sample based on # eligible	14 53.8%

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.
Adverse Event Reporting Description	None to report
Arm/Group Title	3RP-Lymphoma
Arm/Group 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. 3RP-Lymphoma: An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
All Cause Mortality
	3RP-Lymphoma
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Serious Adverse Events
	3RP-Lymphoma
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	3RP-Lymphoma
	Affected / at Risk (%)	# Events
Total	0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.