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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01927393
First received: August 20, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Reduction in anxiety [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Two way (2x2) ANOVAs will be conducted to test the differences between groups.


Estimated Enrollment: 484
Study Start Date: December 2014
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927393

Locations
United States, California
City of Hope Medical Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Virginia Sun    800-826-4673    vsun@coh.org   
Principal Investigator: Virginia Sun         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Virginia Sun City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01927393     History of Changes
Other Study ID Numbers: 13270, NCI-2013-01629, 13270, P30CA033572
Study First Received: August 20, 2013
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms
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

ClinicalTrials.gov processed this record on October 02, 2014