Malignant NeoplasmNCT01432431
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff
A study testing spiritual therapy, questionnaire administration and survey administration in people with Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- spiritual therapy, questionnaire administration and survey administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted during the study quarter
- Admitted >= 5 days
- English speaking
- Alert and able to answer questions
Who cannot join
- Non-cancer diagnosis
- Previously accrued to study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- spiritual therapy, questionnaire administration, survey administration, counseling intervention, psychosocial support for caregiver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spiritual therapyProcedure or surgery
Also called spirituality
Undergo palliative spiritual care
questionnaire administrationOther
Ancillary studies
survey administrationOther
Ancillary studies
counseling interventionOther
Also called counseling and communications studies
Undergo palliative spiritual care
psychosocial support for caregiverOther
Undergo palliative spiritual care
psychosocial assessment and careProcedure or surgery
Also called psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment
Undergo palliative spiritual care
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (spiritual care) | Experimental | See Detailed Description. Receives: Procedure: spiritual therapy; Other: questionnaire administration; Other: survey administration; Other: counseling intervention; Other: psychosocial support for caregiver; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and quarterly for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jay Thomas, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432431
- Sponsor's protocol ID
- 11110
- Other IDs
- NCI-2011-02730
- Status last verified
- Sep 2013
- First submitted
- 8 Sep 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff
- ClinicalTrials.gov ID
- NCT01432431
- Acronym / sponsor ID
- 11110
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (spiritual care) | Experimental | Procedure: spiritual therapy, Other: questionnaire administration, Other: survey administration, Other: counseling intervention, Other: psychosocial support for caregiver, Procedure: psychosocial assessment and careSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted during the study quarter
- Admitted >= 5 days
- English speaking
- Alert and able to answer questions
Key exclusion criteria (2 listed)
- Non-cancer diagnosis
- Previously accrued to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spiritual therapyAlso: spiritualityUndergo palliative spiritual care | Procedure or surgery | Supportive care (spiritual care) |
| questionnaire administrationAncillary studies | Other | Supportive care (spiritual care) |
| survey administrationAncillary studies | Other | Supportive care (spiritual care) |
| counseling interventionAlso: counseling and communications studiesUndergo palliative spiritual care | Other | Supportive care (spiritual care) |
| psychosocial support for caregiverUndergo palliative spiritual care | Other | Supportive care (spiritual care) |
| psychosocial assessment and careAlso: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessmentUndergo palliative spiritual care | Procedure or surgery | Supportive care (spiritual care) |
Primary outcome
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
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
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
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
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
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
Analyzed using Atlas.ti. coding and analysis. Qualitative data, e.g., open ended questions, included narrative responses by staff summarized for reporting purposes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Thomas principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spiritual therapy, questionnaire administration and survey administration in people with Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.