Community-Led Action Research in Oncology: Improving Symptom Management

Depression Clinical Trial

— CLARO  

Official title:

Community-Led Action Research in Oncology: Improving Symptom Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208816
• Other study ID #: CPHS30340
• Status: Completed
• Phase: N/A
• First received: June 22, 2017
• Last updated: March 23, 2018
• Start date: July 24, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Honduras	La Liga Contra el Cancer	San Pedro Sula
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Countries where clinical trial is conducted

United States,  Honduras, 

Outcome

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