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

City of Hope

Status: Withdrawn

Conditions: Stage IIIA Ovarian Germ Cell Tumor; Stage III Pancreatic Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Ovarian Epithelial Cancer; Stage IV Pancreatic Cancer; Stage IV Ovarian Epithelial Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IIIA Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor; Stage IIIC Ovarian Epithelial Cancer; Recurrent Pancreatic Cancer; Stage IIIB Ovarian Germ Cell Tumor

Treatments: Other: questionnaire administration; Behavioral: telephone-based intervention; Other: palliative care; Procedure: quality-of-life assessment; Behavioral: educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01927393

P30CA033572 (U.S. NIH Grant/Contract)

13270 (Other Identifier)

NCI-2013-01629 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I (PCPI)

Experimental group

Description:

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.

Treatment:

Behavioral: educational intervention

Other: palliative care

Procedure: quality-of-life assessment

Other: questionnaire administration

Arm II (standard care plus attention control)

Active Comparator group

Description:

Patients receive standard care plus attention comprising two telephone contacts.

Treatment:

Procedure: quality-of-life assessment

Other: questionnaire administration

Behavioral: telephone-based intervention