Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer Undergoing Outpatient Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Mean Satisfaction score at 8 weeks
Study Overview
Brief Summary
This study examines Stress Management and Resilience Training (SMART) for family caregivers (FCG) of patients receiving chemotherapy for advanced cancer to potentially help with the stressful aspects of providing care. All participants will receive the SMART intervention.
Detailed Description
FCGs experience stress and extensive demands in providing care for those with head and neck cancer. Teaching the principles of mindfulness and compassion to FCGs has the potential to protect their psychological health and well-being. This may allow them to provide effective, compassionate care to patients, which ultimately puts the needs of the patient first.
Mindfulness interventions have demonstrated decreased stress and anxiety, and improved self-compassion for individuals, but entail numerous sessions over several weeks, a barrier for caregivers. The SMART program, a brief mindfulness program, has demonstrated improvements in resilience, anxiety, perceived stress, and mindfulness for healthcare providers and patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary caregiver of patient with advanced head and neck cancer receiving chemotherapy, living with the patient at least 50% of the time during treatment, able to read and speak English, cognitively intact, able to take SMART class within 2 weeks of enrollment
Exclusion Criteria
- •Self-identified mental health diagnoses, less than 18 years of age, not living with patient at least 50% of the time, unable to read and speak English
Arms & Interventions
SMART intervention
90-minute SMART small group session
Intervention: SMART intervention (Behavioral)
Outcomes
Primary Outcomes
Mean Satisfaction score at 8 weeks
Time Frame: Week 8
The Was It Worth It (WiWi) questionnaire measures satisfaction in seven questions. The questions are answered as either "yes, no, or unsure," overall perception of life change and experience, an open-ended response question, and an option to talk with someone about concerns. Positive responses will indicate acceptability; results reported as individual items.
Change in Mean Self Compassion Scale-Short Form Score at 8 weeks
Time Frame: Baseline and Week 8
The Self Compassion Scale-Short Form will measure self-compassion. This form includes 12 items that are measured on a 4-point scale from "never" to "very often" with higher score indicating a higher level of perceived stress; some of these items are scored in reverse.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sherry S. Chesak
Principal Investigator
Mayo Clinic