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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

Primary Purpose

Ovarian Cancer, Transitional Care Planning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telephone-based intervention
counseling intervention
educational intervention
medical chart review
questionnaire administration
psychosocial assessment and care
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Ovarian Cancer focused on measuring transitional care planning, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2009
Last Updated
August 9, 2010
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00900679
Brief Title
Effects of a Teaching Intervention With an Advanced Practice Nurse on Quality of Life and Psychosocial and Symptom Distress in Patients With Ovarian Cancer
Official Title
A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Transitional Care Planning
Keywords
transitional care planning, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Study Phase
Not Applicable
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
telephone-based intervention
Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 3 months
Title
Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Grant, RN, DNSc, FAAN
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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