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Study Status: Withdrawn
Recruit Status: Withdrawn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