Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: Resilient Living Program

• Registration Number: NCT04480008
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to find out if the Resilient Living Program will improve quality of life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and their caregivers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-02
• Study Start: 2020-07-15
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

• As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
• Other psychological co-morbidities such as untreated schizophrenia, bipolar disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resilient Living Program	Resilient Living Program	All participants will be in the Resilient Living Program arm. Study participation involves participating in a 12-week stress management and resilience training program. This will involve four virtual sessions (video or phone) and answering questions about their health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress	Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)	Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
Change in Anxiety	Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)	Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States