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

Primary Purpose

Breast Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growing Resiliency And CouragE with Cancer™ (GRACE)
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring logotherapy, cognitive behavior therapy, metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

GRACE's Impact on Existential Distress (measured by survey)

Secondary Outcome Measures

GRACE's Impact on Existential Distress (measured by survey)
GRACE's Impact on anxiety (measured by survey)
GRACE's Impact on anxiety (measured by survey)
GRACE's Impact on depression (measured by survey)
GRACE's Impact on depression (measured by survey)
GRACE's Impact on hopelessness (measured by survey)
GRACE's Impact on hopelessness (measured by survey)
GRACE's Impact on loneliness (measured by survey)
GRACE's Impact on loneliness (measured by survey)

Full Information

First Posted
March 9, 2016
Last Updated
May 27, 2020
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02707510
Brief Title
A Trial to Strengthen Existential Resiliency Among Women With Metastatic Breast Cancer
Official Title
A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Metastasis
Keywords
logotherapy, cognitive behavior therapy, metastatic breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Growing Resiliency And CouragE with Cancer™ (GRACE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
GRACE's Impact on Existential Distress (measured by survey)
Time Frame
Baseline to 6 weeks after baseline
Secondary Outcome Measure Information:
Title
GRACE's Impact on Existential Distress (measured by survey)
Time Frame
Baseline to 10 weeks after baseline
Title
GRACE's Impact on anxiety (measured by survey)
Time Frame
Baseline to 6 weeks after baseline
Title
GRACE's Impact on anxiety (measured by survey)
Time Frame
Baseline to 10 weeks after baseline
Title
GRACE's Impact on depression (measured by survey)
Time Frame
Baseline to 6 weeks after baseline
Title
GRACE's Impact on depression (measured by survey)
Time Frame
Baseline to 10 weeks after baseline
Title
GRACE's Impact on hopelessness (measured by survey)
Time Frame
Baseline to 6 weeks after baseline
Title
GRACE's Impact on hopelessness (measured by survey)
Time Frame
Baseline to 10 weeks after baseline
Title
GRACE's Impact on loneliness (measured by survey)
Time Frame
Baseline to 6 weeks after baseline
Title
GRACE's Impact on loneliness (measured by survey)
Time Frame
Baseline to 10 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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