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)
37
Enrollment
1
Location
1
Arm
13.7
Actual Duration (Months)
2.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Massachusetts General HospitalBostonMassachusettsUnited States02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • American Cancer Society, Inc.

    Investigators

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

    Study Documents (Full-Text)

    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsScreening 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 DetailIndividuals 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 Title3RP-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
    STARTED37
    Remained Eligible35
    Baseline Completion30
    Program Initiation26
    Post-intervention Survey22
    One Month Follow-up21
    COMPLETED21
    NOT COMPLETED16

    Baseline Characteristics

    Arm/Group Title3RP-Lymphoma
    Arm/Group DescriptionIndividuals who initiated and participated in any 3RP-lymphoma session
    Overall Participants26
    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
    TitleProgram Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions
    DescriptionThe 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 Frame1 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 Title3RP-Lymphoma
    Arm/Group DescriptionIndividuals who initiated and participated in any 3RP-lymphoma session
    Measure Participants26
    Count of Participants [Participants]
    20
    76.9%
    2. Primary Outcome
    TitleNumber of Participants Who Found the 3RP Program Acceptable
    DescriptionAcceptability 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 Frame1 month after completing the 3RP-Lymphoma program

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title3RP-Lymphoma
    Arm/Group DescriptionIndividuals who initiated and participated in any 3RP-lymphoma session and completed the 1 month follow up survey
    Measure Participants21
    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
    TitleNumber of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples
    DescriptionThe investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.
    Time Frame1 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 Title3RP-Lymphoma
    Arm/Group DescriptionIndividuals who initiated and participated in any 3RP-lymphoma session
    Measure Participants26
    Total eligible to provide a sample
    20
    76.9%
    Total provided sample based on # eligible
    14
    53.8%

    Adverse Events

    Time FrameAdverse 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 Title3RP-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
    Total0/26 (0%)
    Serious Adverse Events
    3RP-Lymphoma
    Affected / at Risk (%)# Events
    Total0/26 (0%)
    Other (Not Including Serious) Adverse Events
    3RP-Lymphoma
    Affected / at Risk (%)# Events
    Total0/26 (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.

    Results Point of Contact

    Name/TitleDr. Giselle K. Perez
    OrganizationMassachusetts General Hospital/Harvard Medical School
    Phone617-724-0765
    Emailgperez@mgh.harvard.edu
    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