Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

Lymphoma Clinical Trial

Official title:

Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212261
• Other study ID #: 17-063
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: September 24, 2018

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 24, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma

Intervention

Behavioral:
• 3RP-Lymphoma
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after completing the 3RP-Lymphoma program
Primary	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.	1 month after completing the 3RP-Lymphoma program
Secondary	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.	1 month after completing the 3RP-Lymphoma program