Community-Led Action Research in Oncology: Improving Symptom Management

Not Applicable

Completed

• Conditions: Anxiety; Chemotherapy-induced Nausea and Vomiting; Chemotherapy-induced Neutropenia; Depression; Fatigue; Neoplasms
• Interventions: Behavioral: symptom management program for chemotherapy patients

• Registration Number: NCT03208816
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2017-07-24
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	symptom management program for chemotherapy patients	symptom management program for chemotherapy patients

Primary Outcome Measures

Name	Time	Method
Recruitment feasibility	Through study completion , an average of one year	Number patients enrolled in the study divided by number of patients referred to the study

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

La Liga Contra el Cancer; 🇭🇳 San Pedro Sula, Honduras