Chemotherapy-induced NeutropeniaCLARONCT03208816
Community-Led Action Research in Oncology: Improving Symptom Management
A study testing symptom management program for chemotherapy patients in people with Chemotherapy-induced Neutropenia and Chemotherapy-induced Nausea and Vomiting, run by Dartmouth-Hitchcock Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Anxiety
- What is being tested?
- symptom management program for chemotherapy patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jul 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not start planned chemotherapy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Anxiety, Depression, Fatigue, Neoplasms
- Being tested
- symptom management program for chemotherapy patients
- Keywords
- pain, constipation
- Medical subject headings
- Vomiting, Anxiety Disorders, Depression, Fatigue, Neoplasms, Pain, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom management program for chemotherapy patientsBehavioural
Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | symptom management program for chemotherapy patients Receives: Behavioral: symptom management program for chemotherapy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Number patients enrolled in the study divided by number of patients referred to the study
Measured: Through study completion , an average of one year
Secondary outcomes (4)
Intervention feasibility
Average number of minutes for each telephone sessions
Measured: Through study completion, an average of one year
Fidelity to treatment
Average fidelity score for rated telephone sessions
Measured: Through study completion, an average of one year
Acceptability of intervention
Semi-structured interview of patients and nurse interventionists
Measured: At study completion, approximately one year
Healthcare utilization
Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan
Measured: 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start24 Jul 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Lyons, Dartmouth-Hitchcock Medical Center
- Investigators
- Kathleen D Lyons, ScD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208816
- Sponsor's protocol ID
- CPHS30340
- Acronym
- CLARO
- Status last verified
- Mar 2018
- First submitted
- 22 Jun 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30755109
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Led Action Research in Oncology: Improving Symptom Management
- ClinicalTrials.gov ID
- NCT03208816
- Acronym / sponsor ID
- CLARO / CPHS30340
- Conditions
- Chemotherapy-induced Neutropenia, Chemotherapy-induced Nausea and Vomiting, Anxiety, Depression, Fatigue, Neoplasms
- Keywords
- pain, constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Behavioral: symptom management program for chemotherapy patientssymptom management program for chemotherapy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not start planned chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| symptom management program for chemotherapy patientsNurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy. | Behavioural | single arm |
Primary outcome
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
4 secondary outcomes
Intervention feasibility
Time frame: Through study completion, an average of one year
Fidelity to treatment
Time frame: Through study completion, an average of one year
Acceptability of intervention
Time frame: At study completion, approximately one year
Healthcare utilization
Time frame: 12 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 30755109Bejarano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen D Lyons, ScD principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symptom management program for chemotherapy patients in people with Chemotherapy-induced Neutropenia and Chemotherapy-induced Nausea and Vomiting, run by Dartmouth-Hitchcock Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Through study completion , an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.