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Community-Led Action Research in Oncology: Improving Symptom Management (CLARO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208816
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kathleen Lyons, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Chemotherapy-induced Nausea and Vomiting Anxiety Depression Fatigue Neoplasms Behavioral: symptom management program for chemotherapy patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Community-Led Action Research in Oncology: Improving Symptom Management
Actual Study Start Date : July 24, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
single arm
symptom management program for chemotherapy patients
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208816


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Honduras
La Liga Contra el Cancer
San Pedro Sula, Honduras
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Kathleen D Lyons, ScD Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathleen Lyons, PI, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03208816    
Other Study ID Numbers: CPHS30340
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Lyons, Dartmouth-Hitchcock Medical Center:
pain
constipation
Additional relevant MeSH terms:
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Neutropenia
Vomiting
Signs and Symptoms, Digestive
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases