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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Receive PCPI
Receive education sessions
Ancillary studies
Ancillary studies
Receive telephone contacts
City of Hope Medical Center
Duarte, California, United States
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: At 6 months
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.
Time frame: Up to 6 months
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