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

Not Applicable

Completed

• Conditions: Neoplasm Metastasis; Breast Neoplasms
• Interventions: Other: Growing Resiliency And CouragE with Cancer™ (GRACE)

• Registration Number: NCT02707510
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-14
• Study Start: 2016-10
• Primary Completion: 2019-03
• Study Completion: 2020-03
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Growing Resiliency And CouragE with Cancer™ (GRACE)	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.

Primary Outcome Measures

Name	Time	Method
GRACE's Impact on Existential Distress (measured by survey)	Baseline to 6 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
GRACE's Impact on anxiety (measured by survey)	Baseline to 10 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 10 weeks after baseline
GRACE's Impact on loneliness (measured by survey)	Baseline to 10 weeks after baseline
GRACE's Impact on Existential Distress (measured by survey)	Baseline to 10 weeks after baseline

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States