NCT03212261

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

August 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

June 21, 2017

Results QC Date

June 21, 2019

Last Update Submit

November 9, 2021

Conditions

Lymphoma

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples

    1 month after completing the 3RP-Lymphoma program

Study Arms (1)

3RP-Lymphoma

EXPERIMENTAL

-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

Interventions

3RP-LymphomaBEHAVIORAL

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

Also known as: Relaxation Response Resiliency Program for Lymphoma
3RP-Lymphoma

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Dr. Giselle K. Perez
Organization
Massachusetts General Hospital/Harvard Medical School
gperez@mgh.harvard.edu
617-724-0765

Study Officials

  • Giselle K. Perez, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Psychiatry at Harvard Medical School

Study Record Dates

First Submitted

June 21, 2017

First Posted

July 11, 2017

Study Start

August 3, 2017

Primary Completion

June 30, 2018

Study Completion

September 24, 2018

Last Updated

November 10, 2021

Results First Posted

October 2, 2019

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)