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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432431
Other study ID # 11110
Secondary ID NCI-2011-02730
Status Completed
Phase N/A
First received September 8, 2011
Last updated September 4, 2013
Start date October 2011
Est. completion date September 2013

Study information

Verified date September 2013
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
spiritual therapy
Undergo palliative spiritual care
Other:
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
counseling intervention
Undergo palliative spiritual care
psychosocial support for caregiver
Undergo palliative spiritual care
Procedure:
psychosocial assessment and care
Undergo palliative spiritual care

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change over time in number of unduplicated palliative care patients screened for spiritual concerns and spiritual history 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. At baseline and quarterly for one year No
Primary Change over time in number and type of spiritual issues 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. At baseline and quarterly for one year No
Primary Change over time in number of referrals to the chaplain and number seen by the chaplain 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. At baseline and quarterly for one year No
Primary Change over time in number of unduplicated palliative care patients with documented spiritual care plan 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. At baseline and quarterly for one year No
Primary Change over time in number of staff development sessions offered and topics, attendance per topic, advance directives, and referrals to hospice 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. At baseline and quarterly for one year No
Primary Identification of common themes and patterns that answer the key evaluation questions Analyzed using Atlas.ti. coding and analysis. Qualitative data, e.g., open ended questions, included narrative responses by staff summarized for reporting purposes. At baseline and quarterly for one year No
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