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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer, Transitional Care Planning

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: telephone-based intervention|nan|
|Other: counseling intervention|nan|
|Other: educational intervention|nan|
|Other: medical chart review|nan|
|Other: questionnaire administration|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transitional care planning, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer