Clinical trial NCT03964896: Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy
Official title: Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Head and Neck Carcinoma
Sarcoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Feasibility of completing nurse-driven telephone triage calls
timeFrame: Up to 25 weeks
Secondary outcomes:
measure: Symptom experience
timeFrame: Up to 25 weeks
measure: Patient Satisfaction
timeFrame: Up to 25 weeks
measure: Number of emergency room visits
timeFrame: Up to 25 weeks
measure: Number of hospital admissions
timeFrame: Up to 25 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Colleen Jernigan
role: PRINCIPAL_INVESTIGATOR
References: