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Clinical Trials/NCT02707510
NCT02707510
Completed
N/A

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

Cedars-Sinai Medical Center1 site in 1 country71 target enrollmentOctober 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Cedars-Sinai Medical Center
Enrollment
71
Locations
1
Primary Endpoint
GRACE's Impact on Existential Distress (measured by survey)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
March 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arash Asher, MD

Director, Cancer Survivorship & Rehabilitation

Cedars-Sinai Medical Center

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline to 6 weeks after baseline

Secondary Outcomes

  • 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)

Study Sites (1)

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