Clinical trial NCT02707510: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: logotherapy
cognitive behavior therapy
metastatic breast cancer
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: GRACE's Impact on Existential Distress (measured by survey)
timeFrame: Baseline to 6 weeks after baseline
Secondary outcomes:
measure: GRACE's Impact on Existential Distress (measured by survey)
timeFrame: Baseline to 10 weeks after baseline
measure: GRACE's Impact on anxiety (measured by survey)
timeFrame: Baseline to 6 weeks after baseline
measure: GRACE's Impact on anxiety (measured by survey)
timeFrame: Baseline to 10 weeks after baseline
measure: GRACE's Impact on depression (measured by survey)
timeFrame: Baseline to 6 weeks after baseline
measure: GRACE's Impact on depression (measured by survey)
timeFrame: Baseline to 10 weeks after baseline
measure: GRACE's Impact on hopelessness (measured by survey)
timeFrame: Baseline to 6 weeks after baseline
measure: GRACE's Impact on hopelessness (measured by survey)
timeFrame: Baseline to 10 weeks after baseline
measure: GRACE's Impact on loneliness (measured by survey)
timeFrame: Baseline to 6 weeks after baseline
measure: GRACE's Impact on loneliness (measured by survey)
timeFrame: Baseline to 10 weeks after baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: