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Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff

This study is currently recruiting participants.
Verified March 2013 by City of Hope Medical Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01432431
First received: September 8, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

This clinical trial studies spiritual care in improving quality of life of patients, caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its treatment has on patients, caregivers and hospital staff.


Condition Intervention
Malignant Neoplasm
 Procedure: spiritual therapy
Other: questionnaire administration
Other: survey administration
Other: counseling intervention
Other: psychosocial support for caregiver
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Change over time in number of unduplicated palliative care patients screened for spiritual concerns and spiritual history [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

  • Change over time in number and type of spiritual issues [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

  • Change over time in number of referrals to the chaplain and number seen by the chaplain [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

  • Change over time in number of unduplicated palliative care patients with documented spiritual care plan [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

  • Change over time in number of staff development sessions offered and topics, attendance per topic, advance directives, and referrals to hospice [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Nonparametric Mann-Whitney University test will be used to test for differences between cohorts of patients and of families at the two different measurement points. The Wilcoxon paired nonparametric test will be used to test for change over time for staff survey results.

  • Identification of common themes and patterns that answer the key evaluation questions [ Time Frame: At baseline and quarterly for one year ] [ Designated as safety issue: No ]
    Analyzed using Atlas.ti. coding and analysis. Qualitative data, e.g., open ended questions, included narrative responses by staff summarized for reporting purposes.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (spiritual care)
See Detailed Description.
 Procedure: spiritual therapy
Undergo palliative spiritual care
Other Name: spirituality
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Other: counseling intervention
Undergo palliative spiritual care
Other Name: counseling and communications studies
Other: psychosocial support for caregiver
Undergo palliative spiritual care
Procedure: psychosocial assessment and care
Undergo palliative spiritual care
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies

Detailed Description:

OBJECTIVES:

I. To improve the quality of spiritual care provided by palliative care teams. II. To measure the effectiveness of integrating spiritual care recommendations in palliative care at City of Hope (COH) and the impact it has on cancer patients, families, and hospital staff.

OUTLINE:

The expanded psychosocial/spiritual assessment administered by social workers includes a spiritual history and a spiritual needs screening. Social worker knowledge and competence is surveyed at baseline, immediately after the course, and after a bedside chaplain-mentoring process. Inpatient cancer patients' and their caregivers' perceptions about spiritual care is surveyed at baseline prior to the social work curriculum and after the course has been completed and the new psychosocial/spiritual assessment has been implemented. Data collected from patients, family members, and staff includes number of unduplicated palliative care patients screened for spiritual concerns, spiritual history, number and type of spiritual issues, number of referrals to the chaplain, number seen by the chaplain, number of unduplicated palliative care patients with documented spiritual care plan, number of staff development sessions offered and topics, attendance per topic, advance directives, and referrals to hospice.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Admitted during the study quarter
  • Admitted >= 5 days
  • English speaking
  • Alert and able to answer questions

Exclusion Criteria:

  • Non-cancer diagnosis
  • Previously accrued to study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432431

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Jay Thomas, MD, PhD     626-256-8750     jthomas@coh.org    
Principal Investigator: Jay Thomas, MD, PhD            
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jay Thomas City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01432431     History of Changes
Other Study ID Numbers: 11110, NCI-2011-02730
Study First Received: September 8, 2011
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013