Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01927393
• Other study ID #: 13270
• Secondary ID: NCI-2013-0162913
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2013
• Last updated: December 18, 2014
• Start date: December 2014

Study information

• Verified date: December 2014
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.

Description:

PRIMARY OBJECTIVES:

I. Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.

II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.

ARM II: Patients receive standard care plus attention comprising two telephone contacts.

After completion of study, patients are followed up at 1, 3, and 6 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of pancreatic or ovarian cancer

• Confirmed stage III or IV disease

• Patients who are within one year from initial diagnosis

• Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations

• Ability to read and/or understand the study protocol requirements, and provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Germinoma
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Pancreatic Neoplasms
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IIIA Ovarian Epithelial Cancer
• Stage IIIA Ovarian Germ Cell Tumor
• Stage IIIB Ovarian Epithelial Cancer
• Stage IIIB Ovarian Germ Cell Tumor
• Stage IIIC Ovarian Epithelial Cancer
• Stage IIIC Ovarian Germ Cell Tumor
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Stage IV Pancreatic Cancer

Intervention

Other:
• palliative care
Receive PCPI

Behavioral:
• educational intervention
Receive education sessions

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Behavioral:
• telephone-based intervention
Receive telephone contacts

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	Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)	The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.	Up to 6 months	No
Primary	Symptom burden using the FACT-Trial Outcome Index (TOI)	Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.	Up to 6 months	No
Secondary	Reduction in anxiety	Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.	Up to 6 months	No
Secondary	Reduction in depression	Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.	Up to 6 months	No
Secondary	Overall survival	Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables.	At 6 months	No
Secondary	Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death	Two way (2x2) ANOVAs will be conducted to test the differences between groups.	Up to 6 months	No