StressForTeNCT05702723
Building Resiliency Among Caregivers of Curvivors and Metavivors
A study testing Smart-3RP in people with Stress and Cancer Diagnosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Cancer Diagnosis, Distress, Emotional
- What is being tested?
- Smart-3RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking adult patients with cancer (18 years or older)
- Treated at MGH, who are either within approximately:
- 3 months to 3 years after completing potentially curative therapy for cancer diagnosis including surgery, radiation, and/or chemotherapy or other novel therapies (e.g., immunotherapy, biological therapy). Patients can be on long- term maintenance hormonal or biological therapy at the time of enrollment.
- 3 months after diagnosis of metastatic disease with an expected prognosis of >1 year as confirmed by the treating oncology clinician
- Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study
- Adult caregiver (age 18 years or older).
- Identified by the patient as the spouse/partner or family member/friend.
Who cannot join
- Prognosis less than one year as determined by the treating oncology clinician
- Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician
- Patients without a caregiver who is willing to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
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).
Read the detailed description
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.
- Conditions
- Stress, Cancer Diagnosis, Distress, Emotional
- Being tested
- Smart-3RP, Enhanced Usual Care
- Keywords
- Stress, Stress Management, Cancer Survivors, Cancer Diagnosis, Emotional Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-3RPBehavioural
Also called Stress Management and Resiliency Training-Relaxation Response Program
9 sessions of mind-body group treatment program via Zoom platform.
Enhanced Usual CareBehavioural
14-week group-based, online support group through CancerCare.org.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* Baseline questionnaires.
* 9 virtual sessions of Smart-3RP.
* 3-month questionnaires.
* Optional collections of hair samples at enrollment and 6-month follow-up period to measure cortisol concentration.
* 6-month questionnaires.
* Optional exit interview with study staff. Receives: Behavioral: Smart-3RP |
| 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.
* Participants will be referred to a 14-week online support group. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At 3 months
Secondary outcomes (2)
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.
Measured: At 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start10 Jun 2023
- Primary completion1 Oct 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elyse Park, PhD, Massachusetts General Hospital
- Investigators
- Elyse Park, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702723
- Sponsor's protocol ID
- 22-357
- Other IDs
- R21CA273785
- Acronym
- ForTe
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40606212
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05702723
- Acronym / sponsor ID
- ForTe / 22-357
- Conditions
- Stress, Cancer Diagnosis, Distress, Emotional
- Keywords
- Stress, Stress Management, Cancer Survivors, Cancer Diagnosis, Emotional Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart-3RP | Experimental | Behavioral: Smart-3RPSurvivors-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: * Baseline questionnaires. * 9 virtual sessions of Smart-3RP. * 3-month questionnaires. * Optional collections of hair samples at enrollment and 6-month follow-up period to measure cortisol concentration. * 6-month questionnaires. * Optional exit interview with study staff. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareSurvivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization. * Participants will be referred to a 14-week online support group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Adult caregiver (age 18 years or older).
- Identified by the patient as the spouse/partner or family member/friend.
Key exclusion criteria (3 listed)
- Prognosis less than one year as determined by the treating oncology clinician
- Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician
- Patients without a caregiver who is willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart-3RPAlso: Stress Management and Resiliency Training-Relaxation Response Program9 sessions of mind-body group treatment program via Zoom platform. | Behavioural | Smart-3RP |
| Enhanced Usual Care14-week group-based, online support group through CancerCare.org. | Behavioural | Enhanced Usual Care |
Primary outcome
Proportion of Enrolled Participants (Feasibility)
Time frame: At Screening
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).
Proportion of Intervention Satisfaction (Acceptability)
Time frame: At 3 months
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.
2 secondary outcomes
Proportion of Study Retention (Feasibility)
Time frame: At 3 months
Proportion of Intervention Session Completion (Feasibility)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40606212Goshe 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elyse Park, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart-3RP in people with Stress and Cancer Diagnosis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Enrolled Participants (Feasibility) (time frame: At Screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.