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

May 27, 2020 updated by: Arash Asher, MD, Cedars-Sinai Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (ESTIMATE)

March 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00043233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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