Community-Led Action Research in Oncology: Improving Symptom Management

NCT ID: NCT03208816

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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single arm

symptom management program for chemotherapy patients

Group Type OTHER

symptom management program for chemotherapy patients

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Lyons

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen D Lyons, ScD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

La Liga Contra el Cancer

San Pedro Sula, , Honduras

Site Status

Countries

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United States Honduras

References

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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.

Reference Type DERIVED
PMID: 30755109 (View on PubMed)

Other Identifiers

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CPHS30340

Identifier Type: -

Identifier Source: org_study_id

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