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

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ClinicalTrials.gov Identifier: NCT03964896
Recruitment Status : Active, not recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Head and Neck Carcinoma Sarcoma Other: Survey Other: Survey Administration Behavioral: Telephone-Based Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting
Actual Study Start Date : October 17, 2016
Estimated Primary Completion Date : October 17, 2019
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (telephone intervention)
During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.
Other: Survey
Complete survey
Other Name: Survey Instrument

Other: Survey Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive telephone calls




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Symptom experience [ Time Frame: 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.

  2. Patient Satisfaction [ Time Frame: 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.

  3. Number of emergency room visits [ Time Frame: 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.

  4. Number of hospital admissions [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964896


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Colleen Jernigan M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03964896     History of Changes
Other Study ID Numbers: 2016-0300
NCI-2019-02651 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0300 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases