Advanced Cancer Clinical Trial
Official title:
Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 27, 2021 |
Est. primary completion date | December 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Perceived Stress | 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. | Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions) | |
Primary | Change in Anxiety | 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. | Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions) |
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