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Effects of a Teaching Intervention With an Advanced Practice Nurse on Quality of Life and Psychosocial and Symptom Distress in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900679
First Posted: May 13, 2009
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center
  Purpose

RATIONALE: A teaching intervention with an advanced practice nurse may help reduce psychosocial and symptom distress and improve the well-being and quality of life of patients with ovarian cancer.

PURPOSE: This clinical trial is studying the effects of a teaching intervention with an advanced practice nurse on quality of life and psychosocial and symptom distress in patients with ovarian cancer.


Condition Intervention
Ovarian Cancer Transitional Care Planning Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Other: medical chart review Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type: Interventional
Official Title: A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 3 months
  • Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 6 months

Estimated Enrollment: 110
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To compare the effects of a standardized nursing intervention protocol (SNIP) model with an advanced practice nurse vs usual care on overall quality of life and psychological distress from initial treatment to 6 months after diagnosis in patients with ovarian cancer.
  • To compare symptom control in these patients.
  • To compare geriatric assessment outcomes in these patients.
  • To compare the effects of the SNIP intervention vs usual care on resource use by these patients.
  • To test the effects of SNIP on patients' and clinicians' satisfaction with care.
  • To describe the effects of SNIP on management of transitions from one phase of chronic illness to another.
  • To identify subgroups of patients with ovarian cancer who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
  • To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of ovarian cancer patients.

OUTLINE: Patients are stratified according to age (18 to 60 years vs 61 years and over). Patients are sequentially enrolled into 1 of 2 groups. Patients are initially enrolled in group I. Once enrollment in group I is completed, additional patients are enrolled in group II.

  • Group I (usual care): Patients complete questionnaires, including the FACT-Ovarian, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, and Comprehensive Geriatric Assessment, at baseline and at 3 and 6 months. Clinicians also complete questionnaires, including the Clinician Satisfaction with Intervention Questionnaire. Patients' medical charts are reviewed to collect information about treatment, episodes of care, and readmissions.
  • Group II (advanced practice nurse [APN] intervention): Patients undergo face-to-face individualized teaching sessions with an APN twice a month for 2 months. The sessions focus on the patient's physical, psychological, social, and spiritual well-being and the content is tailored to the patient's preferences and needs. Patients are then contacted by the APN via telephone once a month for 4 months to clarify questions and content from the teaching sessions, review any patient concerns, including concerns associated with a transition, and coordinate interdisciplinary resources, including community resources, as needed. Patients and clinicians complete questionnaires as in group I. Patients' medical charts are also reviewed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian cancer (any stage)

PATIENT CHARACTERISTICS:

  • Lives within a 30-mile radius of City of Hope National Medical Center
  • No prior cancer

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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): NCT00900679


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marcia Grant, RN, DNSc, FAAN City of Hope Comprehensive Cancer Center
  More Information

Responsible Party: Marcia Grant, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00900679     History of Changes
Other Study ID Numbers: 08032
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-08032
CDR0000629411 ( Registry Identifier: PDQ )
First Submitted: May 12, 2009
First Posted: May 13, 2009
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by City of Hope Medical Center:
transitional care planning
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders