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

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ClinicalTrials.gov Identifier: NCT01927393
Recruitment Status : Withdrawn (Study was not funded)
First Posted : August 22, 2013
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Pancreatic Cancer Stage III 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 IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor Stage IV Pancreatic Cancer Other: palliative care Behavioral: educational intervention Procedure: quality-of-life assessment Other: questionnaire administration Behavioral: telephone-based intervention Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers
Study Start Date : December 2014
Estimated Primary Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (PCPI)
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.
 Other: palliative care
Receive PCPI

Behavioral: educational intervention
Receive education sessions
Other Name: intervention, educational

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies
Active Comparator: Arm II (standard care plus attention control)
Patients receive standard care plus attention comprising two telephone contacts.
 Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies

Behavioral: telephone-based intervention
Receive telephone contacts


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927393


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Virginia Sun City of Hope Medical Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01927393     History of Changes
Other Study ID Numbers: 13270
NCI-2013-01629 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13270 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Germinoma
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Neoplasms by Histologic Type