Cancer
Conditions
Keywords
Cancer, Behavioral Intervention, Adolescent, Young Adult
Brief summary
This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.
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 adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.
Interventions
OTHERWaitlist control
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. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.
OTHER3RP-AYA
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.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with any cancer between ages 14 and 29 * Completed cancer treatment within the past 5 years * At least 16 years of age at time of enrollment
Exclusion criteria
* Unwilling or unable to participate in the study * Unable to speak or read English * Is medically or otherwise unable to participate (as determined by a physician or study PI) * Unwilling or unable to participate in study sessions delivered via the Partners Telehealth videoconferencing software * Participation in a focus group during Phase 1 (DF/HCC 17-315)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | Post-treatment completion (treatment is approximately 8 weeks) | Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility. |
| 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program | Post-treatment completion (treatment is approximately 8 weeks) | Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility. |
| 3RP-AYA Acceptability: Five Questions | Post-treatment completion (treatment is approximately 8 weeks) | Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGiselle K. Perez, PhD
Massachusetts General Hospital
Participant flow
Pre-assignment details
As per our approved protocol, only individuals who signed consent and completed the baseline assessment were considered to be enrolled. Hence, 72 people met this criteria.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients All participants who consented and completed the baseline survey | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Continuous | 23.76 years STANDARD_DEVIATION 3.26 |
| Months since treatment completion | 18.82 months STANDARD_DEVIATION 16.06 |
| Race/Ethnicity, Customized Race/ethnicity Asian | 6 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic or Latino | 15 Participants |
| Race/Ethnicity, Customized Race/ethnicity Mixed Race | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 43 Participants |
| Sex/Gender, Customized Gender Female | 53 Participants |
| Sex/Gender, Customized Gender Male | 18 Participants |
| Sex/Gender, Customized Gender Prefer not to describe | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
3RP-AYA Acceptability: Five Questions
Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.
Time frame: Post-treatment completion (treatment is approximately 8 weeks)
Population: These were inclusive of all responses to the acceptability items.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Individuals Approached | 3RP-AYA Acceptability: Five Questions | How enjoyable was the program | 3.62 units on a scale | Standard Deviation 0.69 |
| Total Individuals Approached | 3RP-AYA Acceptability: Five Questions | How helpful was the program? | 3.45 units on a scale | Standard Deviation 0.75 |
| Total Individuals Approached | 3RP-AYA Acceptability: Five Questions | How relevant was the program? | 3.60 units on a scale | Standard Deviation 0.74 |
| Total Individuals Approached | 3RP-AYA Acceptability: Five Questions | How convenient was the program | 3.67 units on a scale | Standard Deviation 0.71 |
| Total Individuals Approached | 3RP-AYA Acceptability: Five Questions | How satisfied are you with the content? | 3.6 units on a scale | Standard Deviation 0.62 |
Primary
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.
Time frame: Post-treatment completion (treatment is approximately 8 weeks)
Population: This consists of the total number of individuals who were eligible, were approached and informed about the study, and were offered the opportunity to participate.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Individuals Approached | 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | Enrolled | 72 Participants |
| Total Individuals Approached | 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | Active refusal | 9 Participants |
| Total Individuals Approached | 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | Passive refusal (made contact but never heard back) | 10 Participants |
| Total Individuals Approached | 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | Interested but unable to make groups | 2 Participants |
Primary
3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.
Time frame: Post-treatment completion (treatment is approximately 8 weeks)
Population: Total number of patients who initiated the program.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Individuals Approached | 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program | Completed 6 out of 8 3RP-AYA sessions. | 55 Participants |
| Total Individuals Approached | 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program | Completed less than 6 3RP-AYA | 9 Participants |