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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707510
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Arash Asher, MD, 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.

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

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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

Resource links provided by the National Library of Medicine


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.



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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707510


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Arash Asher, MD Cedars-Sinai Medical Center
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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    Key Record Dates
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:
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Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases