- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212261
Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Other Names:
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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
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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.
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1 month after completing the 3RP-Lymphoma program
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Number of Participants Who Found the 3RP Program Acceptable
Time Frame: 1 month after completing the 3RP-Lymphoma program
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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.
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1 month after completing the 3RP-Lymphoma program
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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
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The investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.
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1 month after completing the 3RP-Lymphoma program
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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