Breast Carcinoma, Head and Neck Carcinoma, Sarcoma
Conditions
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.
Interventions
OTHERSurvey
Complete survey
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive telephone calls
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of completing nurse-driven telephone triage calls | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Up to 25 weeks | 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. |
| Symptom experience | Up to 25 weeks | 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. |
| Number of emergency room visits | Up to 25 weeks | 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. |
| Number of hospital admissions | Up to 25 weeks | 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. |
Countries
United States
Outcome results
None listed