NCT05702723

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 1, 2023

Results QC Date

December 30, 2025

Last Update Submit

March 24, 2026

Conditions

StressCancer DiagnosisDistress, Emotional

Keywords

StressStress ManagementCancer SurvivorsCancer DiagnosisEmotional Distress

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Proportion of Study Retention (Feasibility)

    At 3 months

  • Proportion of Intervention Session Completion (Feasibility)

    3 months

Study Arms (2)

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.

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.

Behavioral: Enhanced Usual Care

Interventions

Smart-3RPBEHAVIORAL

9 sessions of mind-body group treatment program via Zoom platform.

Also known as: Stress Management and Resiliency Training-Relaxation Response Program
Smart-3RP
Enhanced Usual CareBEHAVIORAL

14-week group-based, online support group through CancerCare.org.

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking adult patients with cancer (18 years or older)
  • Treated at MGH, who are either within approximately:
  • 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.
  • 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

You may not qualify if:

  • 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
  • Adult caregiver (age 18 years or older).
  • Identified by the patient as the spouse/partner or family member/friend.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 40606212DERIVED

Results Point of Contact

Title
Elyse Park, PhD MPH
Organization
Massachusetts General Hospital
epark@mgh.harvard.edu
617-724-6836

Study Officials

  • Elyse Park, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 27, 2023

Study Start

June 10, 2023

Primary Completion

October 1, 2024

Study Completion

January 1, 2025

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)