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| ID | Type | Description | Link |
|---|---|---|---|
| 1K07CA211955-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist Control | Active Comparator |
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| 3RP Group Sessions | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waitlist control | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-treatment completion (treatment is approximately 8 weeks) |
| 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. | Post-treatment completion (treatment is approximately 8 weeks) |
| 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. | Post-treatment completion (treatment is approximately 8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giselle K. Perez, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35080500 | Derived | Mizrach H, Goshe B, Park ER, Recklitis C, Greer JA, Chang Y, Frederick N, Abrams A, Tower MD, Walsh EA, Huang M, Kenney L, Homans A, Miller K, Denninger J, Usmani GN, Peppercorn J, Perez GK. Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study. JMIR Res Protoc. 2022 Jan 26;11(1):e34033. doi: 10.2196/34033. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3RP Group Sessions | The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions immediately after enrollment. |
| FG001 | Waitlist Control | The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions 2-months after enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is a conservative number that consists of all patients who were officially enrolled in the trial (regardless of whether or not they began the intervention), defined as having consented and completed the baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | All participants who consented and completed the baseline survey |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Post-treatment completion (treatment is approximately 8 weeks) |
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Adverse events data was collected from all participants who initiated treatment (n=64) and monitored throughout the duration of the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waitlist Control |
Waitlist 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Giselle K. Perez | Massachusetts General Hospital/Harvard Medical Schoool | 617-724-0765 | gperez@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2021 | Sep 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 3RP-AYA | Other | 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. |
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| Missed final survey (3-month follow-up) |
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| Missed final survey (post-treatment |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Months since treatment completion | Mean | Standard Deviation | months |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Total number of patients who initiated the program. | Posted | Count of Participants | Participants | Post-treatment completion (treatment is approximately 8 weeks) |
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| 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. | These were inclusive of all responses to the acceptability items. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment completion (treatment is approximately 8 weeks) |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 3RP Group Sessions |
| 0 | 33 | 0 | 33 | 0 | 33 |
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| Title | Measurements |
|---|---|
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| How convenient was the program |
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| How satisfied are you with the content? |
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