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

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03208816
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Actual Duration (Months): 5.3
• Patients Per Site: 12.5
• Patients Per Site Per Month: 2.4

Study Details

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.

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	N/A

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.

Study Design

• Study Type: Interventional
• 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.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: Jul 24, 2017
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Recruitment feasibility [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 [Through study completion, an average of one year]

   Average number of minutes for each telephone sessions

2. Fidelity to treatment [Through study completion, an average of one year]

   Average fidelity score for rated telephone sessions

3. Acceptability of intervention [At study completion, approximately one year]

   Semi-structured interview of patients and nurse interventionists

4. Healthcare utilization [12 weeks after enrollment]

   Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
2	La Liga Contra el Cancer	San Pedro Sula		Honduras

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Lyons, PI, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT03208816
• Other Study ID Numbers: CPHS30340
• First Posted: Jul 6, 2017
• Last Update Posted: Mar 27, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kathleen Lyons, PI, Dartmouth-Hitchcock Medical Center: pain; constipation
• Additional relevant MeSH terms: Neutropenia; Vomiting

Study Results

No Results Posted as of Mar 27, 2018