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

Not Applicable

Withdrawn

• Conditions: Stage IIIB Ovarian Epithelial Cancer; Stage III Pancreatic Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IV Pancreatic Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Pancreatic Cancer; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor
• Interventions: Procedure: quality-of-life assessment; Other: palliative care; Behavioral: educational intervention; Behavioral: telephone-based intervention; Other: questionnaire administration

• Registration Number: NCT01927393
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-22
• Status Verified: 2014-12
• Study Start: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (standard care plus attention control)	quality-of-life assessment	Patients receive standard care plus attention comprising two telephone contacts.
Arm I (PCPI)	quality-of-life assessment	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 I (PCPI)	questionnaire administration	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 (standard care plus attention control)	questionnaire administration	Patients receive standard care plus attention comprising two telephone contacts.
Arm I (PCPI)	educational intervention	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 (standard care plus attention control)	telephone-based intervention	Patients receive standard care plus attention comprising two telephone contacts.
Arm I (PCPI)	palliative care	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.

Primary Outcome Measures

Name	Time	Method
Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)	Up to 6 months	The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.
Symptom burden using the FACT-Trial Outcome Index (TOI)	Up to 6 months	Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.

Secondary Outcome Measures

Name	Time	Method
Reduction in anxiety	Up to 6 months	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.
Reduction in depression	Up to 6 months	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.
Overall survival	At 6 months	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.
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	Up to 6 months	Two way (2x2) ANOVAs will be conducted to test the differences between groups.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States