Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Perceived Stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for patients:
- •Age ≥18 years
- •English fluency
- •No diagnosed severe cognitive impairment
- •Diagnosis of stage IV solid tumor cancer
- •Expected prognosis >6 <18 months
- •Provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Patient baseline distress score ≥4/10 OR identified as having distress that would benefit from program by care team or provider
- •Ability to do first Resilient Living session in person
- •Inclusion Criteria for caregivers:
- •Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study
- •Provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Age ≥18 years
- •English fluency
- •No diagnosed severe cognitive impairment
- •Ability to do first Resilient Living session in person
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
Arms & Interventions
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.
Intervention: Resilient Living Program (Behavioral)
Outcomes
Primary Outcomes
Change in Perceived Stress
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Deirdre R. Pachman
Principal Investigator
Mayo Clinic