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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707510
• Other study ID #: Pro00043233
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GRACE's Impact on Existential Distress (measured by survey)		Baseline to 6 weeks after baseline
Secondary	GRACE's Impact on Existential Distress (measured by survey)		Baseline to 10 weeks after baseline
Secondary	GRACE's Impact on anxiety (measured by survey)		Baseline to 6 weeks after baseline
Secondary	GRACE's Impact on anxiety (measured by survey)		Baseline to 10 weeks after baseline
Secondary	GRACE's Impact on depression (measured by survey)		Baseline to 6 weeks after baseline
Secondary	GRACE's Impact on depression (measured by survey)		Baseline to 10 weeks after baseline
Secondary	GRACE's Impact on hopelessness (measured by survey)		Baseline to 6 weeks after baseline
Secondary	GRACE's Impact on hopelessness (measured by survey)		Baseline to 10 weeks after baseline
Secondary	GRACE's Impact on loneliness (measured by survey)		Baseline to 6 weeks after baseline
Secondary	GRACE's Impact on loneliness (measured by survey)		Baseline to 10 weeks after baseline