Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964896
• Other study ID #: 2016-0300
• Secondary ID: NCI-2019-0265120
• Status: Completed
• Phase: N/A
• Start date: October 17, 2016
• Est. completion date: December 18, 2019

Study information

• Verified date: December 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Head and Neck Carcinoma
• Sarcoma

Intervention

Other:
• Survey
Complete survey
• Survey Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone calls

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of completing nurse-driven telephone triage calls	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.	Up to 25 weeks
Secondary	Symptom experience	Will be measured using the MD Anderson Symptom Inventory (MDASI). This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals. The MDASI will be assessed by center and time point, as well as by time point across all centers.	Up to 25 weeks
Secondary	Patient Satisfaction	This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals. Satisfaction will be assessed by treatment group and by time point, as appropriate. They will also be assessed by center and again across all centers.	Up to 25 weeks
Secondary	Number of emergency room visits	This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals. Number of emergency room visits will be assessed by treatment group and by time point, as appropriate. They will also be assessed by center and again across all centers.	Up to 25 weeks
Secondary	Number of hospital admissions	This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals. Number of hospital admissions will be assessed by treatment group and by time point, as appropriate. They will also be assessed by center and again across all centers.	Up to 25 weeks

External Links

•   MD Anderson Cancer Center Website