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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA273785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The main purpose of this research study is to assess the feasibility and participants' satisfaction of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) and compare this treatment with SMART-3RP versus referral to a group-based, online support group to see which is better for improving resilience and decreasing distress of participants with cancer and their caregivers.
The name of the study intervention involved in this study is:
Smart-3RP (virtual, mind-body group treatment program).
This pilot, randomized controlled trial assesses the feasibility, acceptability, and efficacy of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) for improving resiliency and decreasing distress among caregivers and cancer survivors compared to enhanced usual care.
Participants will be randomly assigned into one of the study groups: Smart-3RP versus referral to a group-based, online support group. Randomization means that a participant is placed into a group by chance.
Participation in this study is expected to last about 180 days.
It is expected about 96 people made up of 48 patients and 48 caregivers will take part in this research study.
The National Institutes of Health (NIH) is supporting this research by providing funding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart-3RP | Experimental | Survivors-caregivers will be randomized together (dyad), stratified by survivor status: curvivor (participants who have completed curative therapy) or metavivor (participants will metastatic disease), using a random plan generator with 1:1 randomization. Participants will complete study procedures as outlined:
|
|
| Enhanced Usual Care | Active Comparator | Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart-3RP | Behavioral | 9 sessions of mind-body group treatment program via Zoom platform. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Enrolled Participants (Feasibility) | Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver). | At Screening |
| Proportion of Intervention Satisfaction (Acceptability) | Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Study Retention (Feasibility) | Defined as the percent of participants (including survivors and caregivers as individuals) who complete the 3-month follow-up survey, with a feasibility cutoff defined as ≥ 70% of participants. | At 3 months |
| Proportion of Intervention Session Completion (Feasibility) |
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Inclusion Criteria for Patients:
English speaking adult patients with cancer (18 years or older)
Treated at MGH, who are either within approximately:
Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study
Exclusion Criteria for Patients:
Inclusion Criteria for Caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse Park, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40606212 | Derived | Goshe BM, Barata A, Finkelstein-Fox L, Cloutier J, Farnam E, Holmbeck K, Waldron E, Perez GK, Malloy L, Miranda I, Hager W, Horick N, El-Jawahri A, Park E. Study protocol for a pilot randomized trial building resiliency among caregivers of cancer curvivors and metavivors. Contemp Clin Trials Commun. 2025 Jun 19;46:101506. doi: 10.1016/j.conctc.2025.101506. eCollection 2025 Aug. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Title | Description |
|---|---|---|
| FG000 | Smart-3RP | Survivors-caregivers will be randomized together (dyad), stratified by survivor status: curvivor (participants who have completed curative therapy) or metavivor (participants will metastatic disease), using a random plan generator with 1:1 randomization. Participants will complete study procedures as outlined:
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| FG001 | Enhanced Usual Care | Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smart-3RP | Due to small sample size, this group represents all participants randomized to the SMART-3RP arm (including caregivers and survivors as individuals). The total number represents individuals rather than dyads. |
| BG001 | Enhanced Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline demographic variables are presented separately for cancer survivors and caregivers |
| 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 | Proportion of Enrolled Participants (Feasibility) | Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver). | Please note that data are reported here for individuals (including caregivers and survivors as individuals). A total of 976 participants (i.e., 488 caregiver+ survivor dyads) were eligible for the study. | Posted | Dec 2025 | Count of Participants | Participants | At Screening |
|
From enrollment until follow-up (i.e., up to 6 months)
Although this is a 2-arm study (SMART-3RP vs. EUC), 4 arms are provided here to present adverse event data for cancer survivors and caregivers separately.
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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 | Smart-3RP Survivors | This arm represents all cancer survivors randomized to SMART-3RP. The total number represents individual cancer survivors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elyse Park, PhD MPH | Massachusetts General Hospital | 617-724-6836 | epark@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 | Jan 29, 2025 | Dec 30, 2025 | Prot_SAP_000.pdf |
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| Enhanced Usual Care | Behavioral | 14-week group-based, online support group through CancerCare.org. |
|
Defined as the percent of participants (including both survivors and caregivers as individuals) who attend at least 6 out of 9 SMART-3RP intervention sessions, with a feasibility cutoff of ≥ 70% of participants. This is relevant only to participants randomized to the SMART-3RP. |
| 3 months |
Due to small sample size, this group represents all participants randomized to the EUC arm (including caregivers and patients as individuals). The total number represents individuals rather than dyads. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Baseline demographic variables are presented separately for cancer survivors and caregivers | Count of Participants | Participants |
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| Race (NIH/OMB) | Baseline demographic variables are presented separately for cancer survivors and caregivers | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Baseline demographic variables are presented separately for cancer survivors and caregivers | Count of Participants | Participants |
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| Enrollment Total | Baseline enrollment is presented separately for cancer survivors and caregivers | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Proportion of Intervention Satisfaction (Acceptability) | Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition. | Please note that acceptability was only assessed for participants randomized to the SMART-3RP intervention (and not Enhanced Usual Care). We are considering data for the 37 individuals who had available data at program end (a subset of the 48 individuals randomized to receive SMART-3RP). | Posted | Count of Participants | Participants | At 3 months |
|
|
|
| Secondary | Proportion of Study Retention (Feasibility) | Defined as the percent of participants (including survivors and caregivers as individuals) who complete the 3-month follow-up survey, with a feasibility cutoff defined as ≥ 70% of participants. | Please note that the denominator for this feasibility index includes all individual participants who were consented. | Posted | Count of Participants | Participants | At 3 months |
|
|
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| Secondary | Proportion of Intervention Session Completion (Feasibility) | Defined as the percent of participants (including both survivors and caregivers as individuals) who attend at least 6 out of 9 SMART-3RP intervention sessions, with a feasibility cutoff of ≥ 70% of participants. This is relevant only to participants randomized to the SMART-3RP. | Please note that the denominator for this index of feasibility includes all individual participants who were randomized to the SMART-3RP intervention. This index is not applicable to participants who were randomized to EUC. | Posted | Count of Participants | Participants | 3 months |
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| 1 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Enhanced Usual Care Survivors | This arm represents all cancer survivors randomized to EUC. The total number represents individual cancer survivors. | 1 | 23 | 0 | 23 | 0 | 23 |
| EG002 | SMART-3RP Caregivers | This arm represents all caregivers randomized to SMART-3RP. The total number represents individual caregivers. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Enhanced Usual Care Caregivers | This arm represents all caregivers randomized to EUC. The total number represents individual caregivers. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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