Community-Led Action Research in Oncology: Improving Symptom Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Community-Led Action Research in Oncology: Improving Symptom Management

Conditions
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Anxiety, Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Depression, Fatigue, Neoplasms

Intervention / Treatment
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* Behavioral: symptom management program for chemotherapy patients


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, constipation