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Completed

NCT Number: NCT02707510

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline to 6 weeks after baseline

Secondary outcomes

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

    Time frame: Baseline to 10 weeks after baseline

  2. GRACE's Impact on anxiety (measured by survey)

    Time frame: Baseline to 6 weeks after baseline

  3. GRACE's Impact on anxiety (measured by survey)

    Time frame: Baseline to 10 weeks after baseline

  4. GRACE's Impact on depression (measured by survey)

    Time frame: Baseline to 6 weeks after baseline

  5. GRACE's Impact on depression (measured by survey)

    Time frame: Baseline to 10 weeks after baseline

  6. GRACE's Impact on hopelessness (measured by survey)

    Time frame: Baseline to 6 weeks after baseline

  7. GRACE's Impact on hopelessness (measured by survey)

    Time frame: Baseline to 10 weeks after baseline

  8. GRACE's Impact on loneliness (measured by survey)

    Time frame: Baseline to 6 weeks after baseline

  9. GRACE's Impact on loneliness (measured by survey)

    Time frame: Baseline to 10 weeks after baseline

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 14, 2016
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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