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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|ClinicalTrials.gov Identifier: NCT00900679|
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : August 11, 2010
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Official Title:||A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
- 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
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
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Marcia Grant, RN, DNSc, FAAN||City of Hope Comprehensive Cancer Center|