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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

Arm | Intervention/treatment |
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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.
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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 |
- 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.
- 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.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

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
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010 |
Principal Investigator: | Virginia Sun | City of Hope Medical Center |
Responsible Party: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT01927393 |
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 |
Pancreatic Neoplasms Ovarian Neoplasms Carcinoma, Ovarian Epithelial Neoplasms, Germ Cell and Embryonal Germinoma Recurrence Neoplasms Disease Attributes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |