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

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02707510
Collaborator
(none)
71
1
2
41
1.7

Study Details

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
  • Other: Growing Resiliency And CouragE with Cancer™ (GRACE)
N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2016
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 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) [Baseline to 6 weeks after baseline]

Secondary Outcome Measures

  1. GRACE's Impact on Existential Distress (measured by survey) [Baseline to 10 weeks after baseline]

  2. GRACE's Impact on anxiety (measured by survey) [Baseline to 6 weeks after baseline]

  3. GRACE's Impact on anxiety (measured by survey) [Baseline to 10 weeks after baseline]

  4. GRACE's Impact on depression (measured by survey) [Baseline to 6 weeks after baseline]

  5. GRACE's Impact on depression (measured by survey) [Baseline to 10 weeks after baseline]

  6. GRACE's Impact on hopelessness (measured by survey) [Baseline to 6 weeks after baseline]

  7. GRACE's Impact on hopelessness (measured by survey) [Baseline to 10 weeks after baseline]

  8. GRACE's Impact on loneliness (measured by survey) [Baseline to 6 weeks after baseline]

  9. GRACE's Impact on loneliness (measured by survey) [Baseline to 10 weeks after baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arash Asher, MD, Director, Cancer Survivorship & Rehabilitation, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02707510
Other Study ID Numbers:
  • Pro00043233
First Posted:
Mar 14, 2016
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Arash Asher, MD, Director, Cancer Survivorship & Rehabilitation, Cedars-Sinai Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2020