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

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ClinicalTrials.gov Identifier: NCT03565757

Recruitment Status : Not yet recruiting

First Posted : June 21, 2018

Last Update Posted : June 25, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Sherry S. Chesak, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Family Caregivers Advanced Cancer	Behavioral: SMART intervention	Not Applicable

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 (Clinical Trial)
Estimated Enrollment :	26 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer Undergoing Outpatient Chemotherapy
Estimated Study Start Date :	June 2018
Estimated Primary Completion Date :	October 2018
Estimated Study Completion Date :	April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565757

Contacts


Contact: Jaclynn Johnson, RN	507-255-8965	Johnson.Jaclynn@mayo.edu

Locations


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

Sponsors and Collaborators

Mayo Clinic

Investigators


Principal Investigator:	Sherry Chesak, PhD, RN	Mayo Clinic

More Information


Responsible Party:	Sherry S. Chesak, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT03565757 History of Changes
Other Study ID Numbers:	17-006696
First Posted:	June 21, 2018 Key Record Dates
Last Update Posted:	June 25, 2018
Last Verified:	June 2018


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Sherry S. Chesak, Mayo Clinic:


Stress Management Resilience

Additional relevant MeSH terms:


Neoplasms

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