Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer

Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer Undergoing Outpatient Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Family Caregivers
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMART intervention; 90-minute SMART small group session	Behavioral: SMART intervention; All participants will attend a 90-minute SMART small group session. This session provides education on the stress response and the principles of gratitude, compassion, mindful presence, and resilient mindset. In addition to the class, there will be follow-up online and written resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Satisfaction score at 8 weeks	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.	Week 8
Change in Mean Self Compassion Scale-Short Form Score at 8 weeks	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.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Sherry Chesak, PhD, RN, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stress Management; Resilience
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 17-006696

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No