Lymphoma
Conditions
Keywords
Lymphoma
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).
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.
Interventions
BEHAVIORAL3RP-Lymphoma
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Sponsors
American Cancer Society, Inc.
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 3RP-Lymphoma Individuals who initiated and participated in any 3RP-lymphoma session | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Became ineligible d/t tech | 2 |
| Overall Study | Family Emergency | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Tech Trouble- No first study visit | 1 |
| Overall Study | Too busy/ No time | 5 |
Baseline characteristics
| Characteristic | 3RP-Lymphoma |
|---|---|
| Age, Continuous | 53.41 Years STANDARD_DEVIATION 12.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: 1 month after completing the 3RP-Lymphoma program
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Enjoyable | Somewhat/Very | 21 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Enjoyable | Not at all/Not very | 0 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Helpful | Somewhat/Very | 21 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Helpful | Not at all/Not very | 0 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Relevant | Somewhat/Very | 21 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Relevant | Not at all/Not very | 0 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Convenient | Somewhat/Very | 19 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Convenient | Not at all/Not very | 2 Participants |
| 3RP-Lymphoma | Number of Participants Who Found the 3RP Program Acceptable | Somewhat/Very likely to do RR in the future | Somewhat/Very | 21 Participants |
| 3RP-Lymphoma | 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 |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3RP-Lymphoma | Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions | 20 Participants |
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.
Time frame: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3RP-Lymphoma | Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples | Total eligible to provide a sample | 20 Participants |
| 3RP-Lymphoma | Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples | Total provided sample based on # eligible | 14 Participants |