Lung CancerNCT03416582
Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
A study testing Symptom Management Education and Nurse Coaching and Drinks Diary in people with Lung Cancer and Mucositis Oral, run by University of Miami at 1 site in United States.
Trial summary
This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mucositis Oral, Dehydration
- What is being tested?
- Symptom Management Education and Nurse Coaching and Drinks Diary
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 22 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head \& Neck Cancer
- Over 18 years old
- Eligible for concurrent Chemoradiation in the first line setting
- Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
- Able to read \& write English or Spanish
Who cannot join
- Under 18 years old
- Underlying Anxiety or Depression (must pass screening tools)
- Medically Diagnosed with a Cognitive Impairment
- No prior Chemotherapy or Radiation treatment
- No access to a telephone
- Blind or Deaf or Illiterate
- Requires assistance with Self-Care ADLs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
About this study
Official title: Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study
This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.
- Conditions
- Lung Cancer, Mucositis Oral, Dehydration, Head and Neck Cancer
- Being tested
- Symptom Management Education and Nurse Coaching, Drinks Diary
- Medical subject headings
- Lung Neoplasms, Stomatitis, Dehydration, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Management Education and Nurse CoachingBehavioural
The registered nurse (RN) will teach good mouth care and management of sore mouth or throat (mucositis) symptoms to the patient for self-management at home. The RN will then call the patient twice every week to continue educating and coaching the patient about the mucositis self-management. The patient will receive the Symptom Management (SxM) Toolkit which is a written educational guide known as the "Cancer Treatment Symptom Management Education Toolkit" geared to help the patient manage their symptoms of sore mouth and throat at home in order to prevent dehydration.
Drinks DiaryBehavioural
The patient will complete the Drinks Diary daily by recording the all oral fluid ingested and also record the number of times the bathroom is used.
| Study group | Role | What they receive |
|---|---|---|
| SMENC Group | Experimental | The Symptom Management Education and Nurse Coaching (SMENC) intervention is a one hour in-person face-to-face education session followed by twice weekly telephone calls conducted all throughout the patient's chemoradiation treatment regimen.
During the telephone call, the patient will report the use of the Drinks Diary. Receives: Behavioral: Symptom Management Education and Nurse Coaching; Behavioral: Drinks Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that completed calls
Defined as the number of participants that completed 80% of the total 12 calls.
Measured: 6 weeks
Duration of phone call
Amount of time of the patient daily phone call (in minutes).
Measured: 6 weeks
Percentage of patients using Intervention materials
Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
Measured: 6 weeks
Secondary outcomes (9)
Attrition Rate
Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.
Measured: 6 weeks
Study Completion Rate
Length of time spent in the study will be expressed as a percent and it is expected that the participants will complete 75% of their planned chemoradiation treatments.
Measured: 6 weeks
Participant Satisfaction
Qualitative analysis of a customized Semi-Structured Interview
Measured: 6 weeks
Change in severity of mucositis
Mucositis severity will be measured daily by the Oral Mucositis Daily Questionnaire (OMDQ).
A score of 0 equals no mucositis severity and high mucositis severity equals a score of 4 on question 2.
Measured: 6 weeks
Change in overall symptom severity
The M.D. Anderson Symptom Inventory - Lung Cancer / Head \& Neck Cancer(MDASI-LC; MDASI-HN) will be used to measure overall severity.
The total MDASI-LC; HN score will be used in the analysis of overall symptom severity. Friedman's test is the test statistic that will be used to measure the effect of the intervention on overall symptom severity per cycle of chemoradiation treatment.
Measured: 10 weeks
Change in quality of life
Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy - Lung and Head \& Neck versions (FACT-L; FACT-H\&N respectively ). The FACT-L \& FACT H\&N are both a five domain, 36 item self-report instrument scored on a 5 point Likert scale (zero to 4) with a score range of 0-144; the higher the score = higher HRQoL.
Measured: 10 weeks
Unscheduled Medical Visits
Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.
Measured: 6 weeks
Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy
The adapted Chronic Disease Self-Efficacy Scale (CDSES) was developed by combining the subscales of Manage Disease in General Scale and the Symptoms Scale for a combined 10 item scale to measure the concept of perceived self-efficacy. Each item is scored 0 to 8; with the higher combined sum score equating to a higher perceived self-efficacy in the participant.
Measured: 10 weeks
Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management
The Partners in Health Scale (PIHS) was designed to measure adherence to treatment, knowledge of disease, management of side effects and management of signs and symptoms over time. The 12 item questionnaire scores each question among the domain categories on a 9 point scale from 0-8 and the higher sum score reflects a higher self-management in the participant.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start29 Nov 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Yechieli, University of Miami
- Investigators
- Raphael Yechieli, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416582
- Sponsor's protocol ID
- 20180475
- Status last verified
- Sep 2019
- First submitted
- 24 Jan 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03416582
- Acronym / sponsor ID
- 20180475
- Conditions
- Lung Cancer, Mucositis Oral, Dehydration, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 31 Jan 2018 (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 is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMENC Group | Experimental | Behavioral: Symptom Management Education and Nurse Coaching, Behavioral: Drinks DiaryThe Symptom Management Education and Nurse Coaching (SMENC) intervention is a one hour in-person face-to-face education session followed by twice weekly telephone calls conducted all throughout the patient's chemoradiation treatment regimen. During the telephone call, the patient will report the use of the Drinks Diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head \& Neck Cancer
- Over 18 years old
- Eligible for concurrent Chemoradiation in the first line setting
- Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
- Able to read \& write English or Spanish
Key exclusion criteria (7 listed)
- Under 18 years old
- Underlying Anxiety or Depression (must pass screening tools)
- Medically Diagnosed with a Cognitive Impairment
- No prior Chemotherapy or Radiation treatment
- No access to a telephone
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 Education and Nurse CoachingThe registered nurse (RN) will teach good mouth care and management of sore mouth or throat (mucositis) symptoms to the patient for self-management at home. The RN will then call the patient twice every week to continue educating and coaching the patient about the mucositis self-management. The patient will receive the Symptom Management (SxM) Toolkit which is a written educational guide known as the "Cancer Treatment Symptom Management Education Toolkit" geared to help the patient manage their symptoms of sore mouth and throat at home in order to prevent dehydration. | Behavioural | SMENC Group |
| Drinks DiaryThe patient will complete the Drinks Diary daily by recording the all oral fluid ingested and also record the number of times the bathroom is used. | Behavioural | SMENC Group |
Primary outcome
Number of participants that completed calls
Time frame: 6 weeks
Defined as the number of participants that completed 80% of the total 12 calls.
Duration of phone call
Time frame: 6 weeks
Amount of time of the patient daily phone call (in minutes).
Percentage of patients using Intervention materials
Time frame: 6 weeks
Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
9 secondary outcomes
Attrition Rate
Time frame: 6 weeks
Study Completion Rate
Time frame: 6 weeks
Participant Satisfaction
Time frame: 6 weeks
Change in severity of mucositis
Time frame: 6 weeks
Change in overall symptom severity
Time frame: 10 weeks
Change in quality of life
Time frame: 10 weeks
Unscheduled Medical Visits
Time frame: 6 weeks
Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy
Time frame: 10 weeks
Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management
Time frame: 10 weeks
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 13 Sep 2019.
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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.
Raphael Yechieli, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Management Education and Nurse Coaching and Drinks Diary in people with Lung Cancer and Mucositis Oral, run by University of Miami at 1 site in United States.
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 5 inclusion and 7 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 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Number of participants that completed calls (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2019.