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

• ClinicalTrials.gov Identifier: NCT02707510
• Recruitment Status: Completed
• First Posted: March 14, 2016
• Last Update Posted: May 28, 2020
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Arash Asher, MD, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms; Neoplasm Metastasis	Other: Growing Resiliency And CouragE with Cancer™ (GRACE)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: March 2019
• Actual Study Completion Date: March 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Arm; 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); 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.
No Intervention: Control Arm; 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.

Outcome Measures

Primary Outcome Measures :

1. GRACE's Impact on Existential Distress (measured by survey) [ Time Frame: Baseline to 6 weeks after baseline ]

Secondary Outcome Measures :

1. GRACE's Impact on Existential Distress (measured by survey) [ Time Frame: Baseline to 10 weeks after baseline ]
2. GRACE's Impact on anxiety (measured by survey) [ Time Frame: Baseline to 6 weeks after baseline ]
3. GRACE's Impact on anxiety (measured by survey) [ Time Frame: Baseline to 10 weeks after baseline ]
4. GRACE's Impact on depression (measured by survey) [ Time Frame: Baseline to 6 weeks after baseline ]
5. GRACE's Impact on depression (measured by survey) [ Time Frame: Baseline to 10 weeks after baseline ]
6. GRACE's Impact on hopelessness (measured by survey) [ Time Frame: Baseline to 6 weeks after baseline ]
7. GRACE's Impact on hopelessness (measured by survey) [ Time Frame: Baseline to 10 weeks after baseline ]
8. GRACE's Impact on loneliness (measured by survey) [ Time Frame: Baseline to 6 weeks after baseline ]
9. GRACE's Impact on loneliness (measured by survey) [ Time Frame: Baseline to 10 weeks after baseline ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Arash Asher, MD; Cedars-Sinai Medical Center

More Information

• Responsible Party: Arash Asher, MD, Director, Cancer Survivorship & Rehabilitation, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02707510
• Other Study ID Numbers: Pro00043233
• First Posted: March 14, 2016
• Last Update Posted: May 28, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Arash Asher, MD, Cedars-Sinai Medical Center:

logotherapy; cognitive behavior therapy; metastatic breast cancer

Additional relevant MeSH terms:

Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Neoplastic Processes; Pathologic Processes; Neoplasms by Site; Breast Diseases; Skin Diseases