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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03565757
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : November 7, 2018
Information provided by (Responsible Party):
Sherry S. Chesak, Mayo Clinic

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.

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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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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 identifier (NCT number): NCT03565757

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Contact: Jaclynn Johnson, RN 507-255-8965

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pamela Peterson, RN    507-255-0068   
Principal Investigator: Sherry Chesak, PhD, RN         
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Sherry Chesak, PhD, RN Mayo Clinic

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Responsible Party: Sherry S. Chesak, Principal Investigator, Mayo Clinic Identifier: NCT03565757     History of Changes
Other Study ID Numbers: 17-006696
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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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
Additional relevant MeSH terms:
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