NCT03964896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

May 23, 2019

Last Update Submit

December 23, 2019

Conditions

Breast CarcinomaHead and Neck CarcinomaSarcoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Symptom experience

    Up to 25 weeks

  • Patient Satisfaction

    Up to 25 weeks

  • Number of emergency room visits

    Up to 25 weeks

  • Number of hospital admissions

    Up to 25 weeks

Study Arms (1)

Supportive Care (telephone intervention)

EXPERIMENTAL

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: SurveyOther: Survey AdministrationBehavioral: Telephone-Based Intervention

Interventions

SurveyOTHER

Complete survey

Also known as: Survey Instrument
Supportive Care (telephone intervention)
Survey AdministrationOTHER

Ancillary studies

Supportive Care (telephone intervention)
Telephone-Based InterventionBEHAVIORAL

Receive telephone calls

Supportive Care (telephone intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsSarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Colleen Jernigan

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

October 17, 2016

Primary Completion

December 18, 2019

Study Completion

December 18, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

US(1)