Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

September 8, 2011

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed

18 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed

Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 8, 2011

Last Update Submit

September 4, 2013

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

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
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
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
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
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
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

Study Arms (1)

Supportive care (spiritual care)

EXPERIMENTAL

See Detailed Description.

Procedure: spiritual therapyOther: questionnaire administrationOther: survey administrationOther: counseling interventionOther: psychosocial support for caregiverProcedure: psychosocial assessment and care