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

NCT02707510 | Completed

• 1 other identifier: Pro00043233
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Keywords

logotherapy; cognitive behavior therapy; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 6 weeks after baseline

Secondary Outcomes (9)

• 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 anxiety (measured by survey)

  Baseline to 10 weeks after baseline

• GRACE's Impact on depression (measured by survey)

  Baseline to 6 weeks after baseline

• GRACE's Impact on depression (measured by survey)

  Baseline to 10 weeks after baseline

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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)

Control Arm

NO INTERVENTION

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.

Interventions

Growing Resiliency And CouragE with Cancer™ (GRACE) OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Asher A, Shirazipour CH, Capaldi JM, Kim S, Diniz M, Jones B, Wertheimer J. A 6-Week Program to Strengthen Resiliency Among Women With Metastatic Cancer: A Randomized Clinical Trial. Oncologist. 2023 Aug 3;28(8):e669-e682. doi: 10.1093/oncolo/oyad091.

  PMID: 37104871 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Survivorship & Rehabilitation

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 14, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)