Cancer Diagnosis, Distress, Emotional, Stress
Conditions
Keywords
Stress, Stress Management, Cancer Survivors, Cancer Diagnosis, Emotional Distress
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).
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.
Interventions
BEHAVIORALSmart-3RP
9 sessions of mind-body group treatment program via Zoom platform.
BEHAVIORALEnhanced Usual Care
14-week group-based, online support group through CancerCare.org.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Patients: * 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
Exclusion criteria
for Patients: * 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 Inclusion Criteria for Caregivers: * Adult caregiver (age 18 years or older). * Identified by the patient as the spouse/partner or family member/friend.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Enrolled Participants (Feasibility) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Study Retention (Feasibility) | At 3 months | 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. |
| Proportion of Intervention Session Completion (Feasibility) | 3 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElyse Park, Ph.D.
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Cancer survivor | 62.2 Years STANDARD_DEVIATION 12.4 |
| Age, Continuous Caregiver | 56.8 Years STANDARD_DEVIATION 13.1 |
| Enrollment Total Cancer Survivors | 24 Participants |
| Enrollment Total Caregivers | 24 Participants |
| Ethnicity (NIH/OMB) Cancer survivors Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Cancer survivors Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Cancer survivors Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Cancer Survivors American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Cancer Survivors Asian | 1 Participants |
| Race (NIH/OMB) Cancer Survivors Black or African American | 1 Participants |
| Race (NIH/OMB) Cancer Survivors More than one race | 0 Participants |
| Race (NIH/OMB) Cancer Survivors Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Cancer Survivors Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) Cancer Survivors White | 39 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 1 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Caregivers White | 22 Participants |
| Sex: Female, Male Cancer Survivors Female | 12 Participants |
| Sex: Female, Male Cancer Survivors Male | 14 Participants |
| Sex: Female, Male Caregivers Female | 14 Participants |
| Sex: Female, Male Caregivers Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 1 / 23 | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 0 / 24 | 0 / 23 | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 | 0 / 24 | 0 / 23 |
Outcome results
None listed