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

Ovarian Cancer Clinical Trial

Official title:

A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900679
• Other study ID #: 08032
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: May 12, 2009
• Last updated: August 9, 2010
• Start date: July 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2010
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Transitional Care Planning

Intervention

Behavioral:
• telephone-based intervention

Other:
• counseling intervention

• educational intervention

• medical chart review

• questionnaire administration

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 3 months			No
Primary	Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 6 months			No