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Completed

NCT Number: NCT03208816

Community-Led Action Research in Oncology: Improving Symptom Management

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.

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Key information

Conditions

Chemotherapy-induced Neutropenia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemotherapy-induced Nausea and Vomiting Constipation Depression Fatigue Mental Disorders Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Liga Contra el Cancer, San Pedro Sula, Honduras

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

symptom management program for chemotherapy patients

Behavioral

Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.

Primary outcomes

  1. 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

Secondary outcomes

  1. Intervention feasibility

    Time frame: Through study completion, an average of one year

    Average number of minutes for each telephone sessions

  2. Fidelity to treatment

    Time frame: Through study completion, an average of one year

    Average fidelity score for rated telephone sessions

  3. Acceptability of intervention

    Time frame: At study completion, approximately one year

    Semi-structured interview of patients and nurse interventionists

  4. Healthcare utilization

    Time frame: 12 weeks after enrollment

    Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: CLARO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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