Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

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.

Official Title
-----------------
Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Behavioral: Resilient Living Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resilient Living Program<br>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. | Behavioral: Resilient Living Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | Week 5 (after 2nd intervention session) | 
| 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. | Week 9 (after 4th intervention session) | 
| 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. | Week 12 (one month after completing all intervention sessions) | 
| 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 | 
| 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. | Week 5 (after 2nd intervention session) | 
| 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. | Week 9 (after 4th intervention session) | 
| 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. | Week 12 (one month after completing all intervention sessions) |