Clinical trial · Interventional

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

Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers

NCT01927393CI-TRIAL-00016432withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Study was not funded

Summary

Brief summary (as posted)

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.

Conditions

Conditions (13)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent Ovarian Epithelial Cancer	Ovarian Carcinoma	CURATED_BROADER	0.78
Recurrent Ovarian Germ Cell Tumor	Ovarian Germ Cell Tumor	CURATED_BROADER	0.78
Recurrent Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_BROADER	0.78
Stage IIIA Ovarian Epithelial Cancer	Ovarian Carcinoma	CURATED_BROADER	0.78
Stage IIIA Ovarian Germ Cell Tumor	Ovarian Germ Cell Tumor	CURATED_BROADER	0.78
Stage IIIB Ovarian Epithelial Cancer	Ovarian Carcinoma	CURATED_BROADER	0.78
Stage IIIB Ovarian Germ Cell Tumor	Ovarian Germ Cell Tumor	CURATED_BROADER	0.78
Stage IIIC Ovarian Epithelial Cancer	Ovarian Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
educational intervention	Behavioral	—	UNRESOLVED
palliative care	Other	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED
questionnaire administration	Other	—	UNRESOLVED
telephone-based intervention	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I (PCPI)
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.
interventionNames
1. Other: palliative care
2. Behavioral: educational intervention
3. Procedure: quality-of-life assessment
4. Other: questionnaire administration
type
ACTIVE_COMPARATOR
label
Arm II (standard care plus attention control)
description
Patients receive standard care plus attention comprising two telephone contacts.
interventionNames
1. Procedure: quality-of-life assessment
2. Other: questionnaire administration
3. Behavioral: telephone-based intervention

Primary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 21 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 1, 2014
Primary completion: Oct 1, 2017
Completion: —
First posted: Aug 22, 2013
Last update posted: Dec 23, 2014
Enrollment: 0 (actual)
Lead sponsor: City of Hope Medical Center OTHER
Collaborators: National Cancer Institute (NCI)

Data updated 22 days agoSource updated Dec 23, 2014source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.