Clinical trial NCT03208816: Community-Led Action Research in Oncology: Improving Symptom Management
Official title: Community-Led Action Research in Oncology: Improving Symptom Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Neutropenia
Chemotherapy-induced Nausea and Vomiting
Anxiety
Depression
Fatigue
Neoplasms
Keywords: pain
constipation
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: Through study completion , an average of one year
Secondary outcomes:
measure: Intervention feasibility
timeFrame: Through study completion, an average of one year
measure: Fidelity to treatment
timeFrame: Through study completion, an average of one year
measure: Acceptability of intervention
timeFrame: At study completion, approximately one year
measure: Healthcare utilization
timeFrame: 12 weeks after enrollment
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: San Pedro Sula
country: Honduras
facility: La Liga Contra el Cancer
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kathleen D Lyons, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.