Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Reduction in anxiety(Up to 6 months)
- Reduction in depression(Up to 6 months)
- Overall survival(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(Up to 6 months)