NCT00903305

Brief Summary

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with breast cancer. PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with stage I, stage II, or stage III breast cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable breast-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

May 15, 2009

Last Update Submit

January 30, 2013

Conditions

Breast CancerFatigueNausea and VomitingPain

Keywords

painfatiguenausea and vomitingstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

  • Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months

  • Long-term impact at 6 months

Study Arms (2)

Group II (SNIP)

EXPERIMENTAL

Patients undergo SNIP comprising four visits over 2 months and four monthly telephone calls from the APN. The APN will provide 24 hour access during the study. Patients complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.

Other: medical chart reviewOther: questionnaire administrationProcedure: fatigue assessment and managementProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

Group I (usual care intervention)

ACTIVE COMPARATOR

Patients undergo usual care and complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.

Other: medical chart reviewOther: questionnaire administrationProcedure: fatigue assessment and managementProcedure: quality-of-life assessment

Interventions

medical chart reviewOTHER
Group I (usual care intervention)Group II (SNIP)
questionnaire administrationOTHER
Group I (usual care intervention)Group II (SNIP)
fatigue assessment and managementPROCEDURE
Group I (usual care intervention)Group II (SNIP)
psychosocial assessment and carePROCEDURE
Group II (SNIP)
quality-of-life assessmentPROCEDURE
Group I (usual care intervention)Group II (SNIP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage I, II, or III breast cancer * Admitted to City of Hope National Medical Center * Resides within a 30-mile radius of the medical center * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * No prior cancer PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsFatigueNauseaVomitingPain

Interventions

TherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveNeurologic Manifestations

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marcia Grant, RN, DNSc, FAAN

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 1, 2013

Record last verified: 2013-01