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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707510
Enrollment
71
Registered
2016-03-14
Start date
2016-10-31
Completion date
2020-03-31
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

Keywords

logotherapy, cognitive behavior therapy, metastatic breast cancer

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.

Interventions

OTHERGrowing 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.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
GRACE's Impact on Existential Distress (measured by survey)Baseline to 6 weeks after baseline

Secondary

MeasureTime frame
GRACE's Impact on Existential Distress (measured by survey)Baseline to 10 weeks after baseline
GRACE's Impact on anxiety (measured by survey)Baseline to 6 weeks after baseline
GRACE's Impact on depression (measured by survey)Baseline to 6 weeks after baseline
GRACE's Impact on hopelessness (measured by survey)Baseline to 6 weeks after baseline
GRACE's Impact on loneliness (measured by survey)Baseline to 6 weeks after baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026