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Community-Led Action Research in Oncology: Improving Symptom Management

Community-Led Action Research in Oncology: Improving Symptom Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03208816
Acronym
CLARO
Enrollment
25
Registered
2017-07-06
Start date
2017-07-24
Completion date
2017-12-31
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pain, constipation

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.

Interventions

BEHAVIORALsymptom 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.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment feasibilityThrough study completion , an average of one yearNumber patients enrolled in the study divided by number of patients referred to the study

Secondary

MeasureTime frameDescription
Intervention feasibilityThrough study completion, an average of one yearAverage number of minutes for each telephone sessions
Fidelity to treatmentThrough study completion, an average of one yearAverage fidelity score for rated telephone sessions
Acceptability of interventionAt study completion, approximately one yearSemi-structured interview of patients and nurse interventionists
Healthcare utilization12 weeks after enrollmentAverage number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan

Countries

Honduras, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026