Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent 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 III Pancreatic Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Pancreatic Cancer
Conditions
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.
Interventions
BEHAVIORALeducational intervention
Receive education sessions
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
BEHAVIORALtelephone-based intervention
Receive telephone contacts
OTHERpalliative care
Receive PCPI
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed