Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer
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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. |
| ClinicalTrials.gov Identifier: NCT03565757 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2018
Last Update Posted : November 7, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Family Caregivers Advanced Cancer | Behavioral: SMART intervention | Not Applicable |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SMART intervention
90-minute SMART small group session
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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. |
- 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.
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.
| 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
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
| Contact: Jaclynn Johnson, RN | 507-255-8965 | Johnson.Jaclynn@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Pamela Peterson, RN 507-255-0068 Peterson.Pamela@mayo.edu | |
| Principal Investigator: Sherry Chesak, PhD, RN | |
| Principal Investigator: | Sherry Chesak, PhD, RN | Mayo Clinic |
| 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: | November 7, 2018 |
| Last Verified: | November 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:
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Stress Management Resilience |
Additional relevant MeSH terms:
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Neoplasms |