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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02776 | Registry Identifier | CTRP (Clinical Trials Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilient Living Program | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilient Living Program | Behavioral | Participants will be given the journal Resilient Living with Dr. Sood: Building Strength for Difficult Days to use throughout the study. The initial session with one of the investigators will be an introduction and a review of Module 1: Gratitude, and will last 30-60min. Three follow-up sessions will occur approximately every two weeks and the participants should view the videos before those virtual meetings (Session 2 will review Module II: Mindful Presence; Session 3 will review Module III: Kindness; Session 4 will review Module IV: Resilient Mindset). The videos will take approximately 30 minutes each to review and virtual sessions will each take 30-60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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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Inclusion Criteria for patients:
Inclusion Criteria for caregivers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deirdre R. Pachman, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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