Ovarian Cancer Clinical Trial
Official title:
A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness
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.
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.
;
N/A
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