Back to resultsCommunity-Led Action Research in Oncology: Improving Symptom Management (CLARO)
Primary Purpose
Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Anxiety
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
symptom management program for chemotherapy patients
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy-induced Neutropenia focused on measuring pain, constipation
Eligibility Criteria
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.
Sites / Locations
- Dartmouth-Hitchcock Medical Center
- La Liga Contra el Cancer
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single arm
Arm Description
symptom management program for chemotherapy patients
Outcomes
Primary Outcome Measures
Recruitment feasibility
Number patients enrolled in the study divided by number of patients referred to the study
Secondary Outcome Measures
Intervention feasibility
Average number of minutes for each telephone sessions
Fidelity to treatment
Average fidelity score for rated telephone sessions
Acceptability of intervention
Semi-structured interview of patients and nurse interventionists
Healthcare utilization
Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan
Full Information
NCT ID
NCT03208816
First Posted
June 22, 2017
Last Updated
March 23, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03208816
Brief Title
Community-Led Action Research in Oncology: Improving Symptom Management
Acronym
CLARO
Official Title
Community-Led Action Research in Oncology: Improving Symptom Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Anxiety, Depression, Fatigue, Neoplasms
Keywords
pain, constipation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Other
Arm Description
symptom management program for chemotherapy patients
Intervention Type
Behavioral
Intervention Name(s)
symptom management program for chemotherapy patients
Intervention Description
Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.
Primary Outcome Measure Information:
Title
Recruitment feasibility
Description
Number patients enrolled in the study divided by number of patients referred to the study
Time Frame
Through study completion , an average of one year
Secondary Outcome Measure Information:
Title
Intervention feasibility
Description
Average number of minutes for each telephone sessions
Time Frame
Through study completion, an average of one year
Title
Fidelity to treatment
Description
Average fidelity score for rated telephone sessions
Time Frame
Through study completion, an average of one year
Title
Acceptability of intervention
Description
Semi-structured interview of patients and nurse interventionists
Time Frame
At study completion, approximately one year
Title
Healthcare utilization
Description
Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan
Time Frame
12 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen D Lyons, ScD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
La Liga Contra el Cancer
City
San Pedro Sula
Country
Honduras
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30755109
Citation
Bejarano S, Freed ME, Zeron D, Medina R, Zuniga-Moya JC, Kennedy L, Bruce ML, Zubkoff L, Bakitas MA, Lyons KD. Feasibility of a Symptom Management Intervention for Honduran Adults Undergoing Chemotherapy. West J Nurs Res. 2019 Oct;41(10):1517-1539. doi: 10.1177/0193945918825374. Epub 2019 Feb 12.
Results Reference
derived
Learn more about this trial
Community-Led Action Research in Oncology: Improving Symptom Management
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