Clinical Trial: Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers
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 Summary:
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.
Sponsor: City of Hope Medical Center
Current Primary Outcome:
- Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reduction in anxiety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 6 months ]Two way (2x2) ANOVAs will be conducted to test the differences between groups.
Original Secondary Outcome: Same as current
Information By: City of Hope Medical Center
Dates:
Date Received: August 20, 2013
Date Started: December 2014
Date Completion:
Last Updated: December 18, 2014
Last Verified: December 2014