Community-Led Action Research in Oncology: Improving Symptom Management (CLARO)

March 23, 2018 updated by: Kathleen Lyons, Dartmouth-Hitchcock Medical Center
This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The overall objective of this project is to improve symptom management for patients undergoing chemotherapy in Honduras. The first step in this line of research is a "proof of concept" feasibility study in which the investigators will demonstrate their ability to train nurses to administer a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will use the team's previous experience delivering a standardized, non-pharmacological palliative care intervention by telephone to inform a "proof of concept" feasibility study in Honduras. They will train nurses at La Liga Contra el Cancer in San Pedro Sula to conduct the telephone sessions and monitor their fidelity to treatment as they enroll a minimum They will then evaluate the feasibility, acceptability, and potential effectiveness of the program.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
      • San Pedro Sula, Honduras
        • La Liga Contra el Cancer
  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are over the age of 18 and are beginning a chemotherapy regimen to treat any solid or hematological cancer will be eligible for the study.

Exclusion Criteria:

  • Patients who do not start planned chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
symptom management program for chemotherapy patients
Behavioral: symptom management program for chemotherapy patients
Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility
Time Frame: Through study completion , an average of one year
Number patients enrolled in the study divided by number of patients referred to the study
Through study completion , an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention feasibility
Time Frame: Through study completion, an average of one year
Average number of minutes for each telephone sessions
Through study completion, an average of one year
Fidelity to treatment
Time Frame: Through study completion, an average of one year
Average fidelity score for rated telephone sessions
Through study completion, an average of one year
Acceptability of intervention
Time Frame: At study completion, approximately one year
Semi-structured interview of patients and nurse interventionists
At study completion, approximately one year
Healthcare utilization
Time Frame: 12 weeks after enrollment
Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan
12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPHS30340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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