Trial Outcomes & Findings for Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma (NCT NCT03212261)

Last Updated: 2021-11-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

1 month after completing the 3RP-Lymphoma program

Results posted on

2021-11-10

Participant Flow

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.

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.

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 3RP-Lymphoma: An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Overall Study Became ineligible d/t tech	2
Overall Study Tech Trouble- No first study visit	1
Overall Study Lost to Follow-up	7
Overall Study Family Emergency	1
Overall Study Too busy/ No time	5

Baseline Characteristics

Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3RP-Lymphoma n=26 Participants Individuals who initiated and participated in any 3RP-lymphoma session
Age, Continuous	53.41 Years STANDARD_DEVIATION 12.15 • n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month after completing the 3RP-Lymphoma program

Population: 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.

Outcome measures

Outcome measures
Measure	3RP-Lymphoma n=26 Participants Individuals who initiated and participated in any 3RP-lymphoma session
Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions	20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	3RP-Lymphoma n=21 Participants Individuals who initiated and participated in any 3RP-lymphoma session
Number of Participants Who Found the 3RP Program Acceptable Enjoyable · Somewhat/Very	21 Participants
Number of Participants Who Found the 3RP Program Acceptable Enjoyable · Not at all/Not very	0 Participants
Number of Participants Who Found the 3RP Program Acceptable Helpful · Somewhat/Very	21 Participants
Number of Participants Who Found the 3RP Program Acceptable Helpful · Not at all/Not very	0 Participants
Number of Participants Who Found the 3RP Program Acceptable Relevant · Somewhat/Very	21 Participants
Number of Participants Who Found the 3RP Program Acceptable Relevant · Not at all/Not very	0 Participants
Number of Participants Who Found the 3RP Program Acceptable Convenient · Somewhat/Very	19 Participants
Number of Participants Who Found the 3RP Program Acceptable Convenient · Not at all/Not very	2 Participants
Number of Participants Who Found the 3RP Program Acceptable Somewhat/Very likely to do RR in the future · Somewhat/Very	21 Participants
Number of Participants Who Found the 3RP Program Acceptable Somewhat/Very likely to do RR in the future · Not at all/Not very	0 Participants

SECONDARY outcome

Timeframe: 1 month after completing the 3RP-Lymphoma program

Population: 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).

The investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.

Outcome measures

Outcome measures
Measure	3RP-Lymphoma n=26 Participants Individuals who initiated and participated in any 3RP-lymphoma session
Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples Total eligible to provide a sample	20 Participants
Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples Total provided sample based on # eligible	14 Participants

Adverse Events

3RP-Lymphoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Giselle K. Perez

Massachusetts General Hospital/Harvard Medical School

Phone: 617-724-0765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place