A Trial to Strengthen Existential Resiliency Among Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving psycho-education and process-oriented experiences. The curriculum includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.

Official Title
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A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer

Conditions
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Breast Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Other: Growing Resiliency And CouragE with Cancer™ (GRACE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with metastatic cancer with a minimum prognosis of 3 months Existential or spiritual concerns Reasonable medical stability as assessed by the evaluating physician Commits to attending 5/6 of the GRACE classes English speaking Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Unstable psychiatric disorder that would detract from a group program (i.e. severe depression/anxiety not controlled medically, volatile personality disorders) Cognitive impairment or cognitive linguistic impairment (i.e., aphasia) that would interfere with a group program.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Patients in the intervention group will be provided with all programmatic materials (including copies of power point presentations, copies of reading texts, and audio CDs) and classes will be held in group format, with a maximum of 9 participants per group. Classes will meet weekly, in a group, and at a set time. All classes will be facilitated jointly by the two Co-PIs. All participants will complete surveys before class, during class, at the end of class, 1 month after the end of class, 6 months after the end of class and 1 year after the end of the class. Additionally, those randomized to the intervention group will be asked to attend a 1 time focus group 1 week after the end of the class. | Other: Growing Resiliency And CouragE with Cancer™ (GRACE)<br>* GRACE is a 6 week curriculum which includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.<br>|
| No Intervention: Control Arm<br>Patients in the control group will be asked to complete surveys at: baseline, 6 weeks after baseline (T1), and 1 month after T1. After T1, the control group will off study and will be permitted to attend the next available GRACE course. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRACE's Impact on Existential Distress (measured by survey) |  | Baseline to 6 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRACE's Impact on Existential Distress (measured by survey) |  | Baseline to 10 weeks after baseline | 
| GRACE's Impact on anxiety (measured by survey) |  | Baseline to 6 weeks after baseline | 
| GRACE's Impact on anxiety (measured by survey) |  | Baseline to 10 weeks after baseline | 
| GRACE's Impact on depression (measured by survey) |  | Baseline to 6 weeks after baseline | 
| GRACE's Impact on depression (measured by survey) |  | Baseline to 10 weeks after baseline | 
| GRACE's Impact on hopelessness (measured by survey) |  | Baseline to 6 weeks after baseline | 
| GRACE's Impact on hopelessness (measured by survey) |  | Baseline to 10 weeks after baseline | 
| GRACE's Impact on loneliness (measured by survey) |  | Baseline to 6 weeks after baseline | 
| GRACE's Impact on loneliness (measured by survey) |  | Baseline to 10 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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logotherapy, cognitive behavior therapy, metastatic breast cancer