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

NCT03565757 | Completed

• 1 other identifier: 17-006696
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Caregivers; Advanced Cancer

Keywords

Stress Management; Resilience

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SMART intervention

EXPERIMENTAL

90-minute SMART small group session

Behavioral: SMART intervention

Interventions

SMART intervention BEHAVIORAL

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.

SMART intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Sherry Chesak, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 21, 2018
• Study Start: July 19, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

US (1)