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Clinical Trials/NCT03964896
NCT03964896
Completed
N/A

Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting

M.D. Anderson Cancer Center1 site in 1 country90 target enrollmentOctober 17, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Carcinoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
90
Locations
1
Primary Endpoint
Feasibility of completing nurse-driven telephone triage calls
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This clinical trial studies how well a nurse-driven telephone intervention improves side effects in patients with cancer who are undergoing chemotherapy. Receiving calls from a nurse at home while receiving chemotherapy may improve the management of side effects and overall care in cancer patients.

Detailed Description

PRIMARY OBJECTIVES: I. To explore the feasibility of a proactive nurse-driven telephone triage intervention for patients with cancer receiving first-line chemotherapy in the ambulatory setting. SECONDARY OBJECTIVES: I. To explore the symptom experience of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. II. To explore the satisfaction of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. III. To explore the frequency of emergency room visits and hospital admissions for symptom management by patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. OUTLINE: During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.

Registry
clinicaltrials.gov
Start Date
October 17, 2016
End Date
December 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • Newly diagnosed patients with a breast, sarcoma, or head and neck cancer diagnosis preparing to undergo first-line, standard of care chemotherapy (patients with head and neck cancer may be undergoing concurrent first-line chemotherapy and radiation treatment)
  • All chemotherapy treatment to be completed at the study institution

Exclusion Criteria

  • Patients who have received previous chemotherapy treatment for cancer
  • Patients who will be receiving chemotherapy on research protocols
  • Pregnant patients, as they may be on unique treatment protocols outside standard of care or have symptom needs that are beyond the scope of this intervention
  • Patients who are unable to verbalize (e.g. due to tracheostomy)

Outcomes

Primary Outcomes

Feasibility of completing nurse-driven telephone triage calls

Time Frame: Up to 25 weeks

Completion is defined as the patient answering the call and completing the assessment; the target completion rate is set as 70%. Completion of nurse-driven calls will be assessed separately by center (breast, sarcoma, head and neck) and globally across all centers. The study will declare the intervention to be feasible within a center if the 90% confidence interval for completion rate is completely above 70% or contains 70%. To calculate the confidence interval, the study will construct a generalized linear mixed model with only a term for intercept.

Secondary Outcomes

  • Patient Satisfaction(Up to 25 weeks)
  • Number of emergency room visits(Up to 25 weeks)
  • Number of hospital admissions(Up to 25 weeks)
  • Symptom experience(Up to 25 weeks)

Study Sites (1)

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