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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00900679
Enrollment
110
Registered
2009-05-13
Start date
2008-07-31
Completion date
2010-02-28
Last updated
2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Transitional Care Planning

Keywords

transitional care planning, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Brief 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.

Detailed 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.

Interventions

BEHAVIORALtelephone-based intervention
OTHERcounseling intervention
OTHEReducational intervention
OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026