Effects of a Teaching Intervention With an Advanced Practice Nurse on Quality of Life and Psychosocial and Symptom Distress in Patients With Ovarian Cancer
|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|
|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|
- 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|
|Primary Completion Date :||February 2010|
|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
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|