Head and Neck CancerNCT02324881
Pain Management Smartphone Application for Patients With Stage III-IV Head and Neck Cancer Undergoing Radiation Therapy
A study testing Telephone-Based Intervention and Questionnaire Administration in people with Head and Neck Cancer and Pain, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pain, Lung Cancer
- What is being tested?
- Telephone-Based Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2015
- 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
- Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer.
- Ability to understand and the willingness to use the PMSA on the patient's personal smartphone
- Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
- Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires
- English speaking
Who cannot join
- Radiation oncology patients undergoing palliative courses of radiation
- Patients who do not own smartphones
- Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
- Patients who are unable to eat and drink normally
- Patients who are unable to validate their understanding of the pain scale
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer
This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.
II. Train patients to use the pain management smartphone application (PMSA) and determine the compliance characteristics and the number of additional on-treatment visits (OTVs) prompted by usage of the application.
OUTLINE:
Selected patients are interviewed for input that will help guide the wording of questions of the PMSA. All patients/caregivers are then instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.
- Conditions
- Head and Neck Cancer, Pain, Lung Cancer, Esophageal Cancer
- Being tested
- Telephone-Based Intervention, Questionnaire Administration
- Keywords
- smartphone, application, pain management
- Medical subject headings
- Head and Neck Neoplasms, Pain, Lung Neoplasms, Esophageal Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Based InterventionBehavioural
Use PSMA
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (PMSA) | Experimental | Patients/caregivers are instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50). The patient will fill out a satisfaction questionnaire at the completion of their treatment (Questionnaire administration). The timing of use may change depending on the availability of the app. The use of the app is classified as the "telephone-based intervention" per NCI. Receives: Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance characteristics of patients' use of the pain management smartphone application
Summaries of feasibility will be generated using rates (percentages). Descriptive statistics will be used to summarize patient ratings of satisfaction regarding the PMSA, instruction, usage, and future recommendation.
Measured: Up to day 50
Secondary outcomes (1)
Number of additional OTVs prompted by usage of the application
The additional OTVs per patient will analyzed with descriptive statistics, such as frequency distributions, means, medians and measures of variability will be used to describe the OTV number changes.
Measured: Up to day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jeffrey Friedman, Vanderbilt-Ingram Cancer Center
- Investigators
- Jeffrey Friedman, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324881
- Sponsor's protocol ID
- VICC HN 14122
- Other IDs
- NCI-2014-02426, VICCHN14122, P30CA068485
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2014
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02324881
- Acronym / sponsor ID
- VICC HN 14122
- Conditions
- Head and Neck Cancer, Pain, Lung Cancer, Esophageal Cancer
- Keywords
- smartphone, application, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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 pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.
Detailed description
PRIMARY OBJECTIVES:
- Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.
II. Train patients to use the pain management smartphone application (PMSA) and determine the compliance characteristics and the number of additional on-treatment visits (OTVs) prompted by usage of the application.
OUTLINE:
Selected patients are interviewed for input that will help guide the wording of questions of the PMSA. All patients/caregivers are then instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (PMSA) | Experimental | Behavioral: Telephone-Based Intervention, Other: Questionnaire AdministrationPatients/caregivers are instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50). The patient will fill out a satisfaction questionnaire at the completion of their treatment (Questionnaire administration). The timing of use may change depending on the availability of the app. The use of the app is classified as the "telephone-based intervention" per NCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer.
- Ability to understand and the willingness to use the PMSA on the patient's personal smartphone
- Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
- Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires
- English speaking
Key exclusion criteria (5 listed)
- Radiation oncology patients undergoing palliative courses of radiation
- Patients who do not own smartphones
- Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
- Patients who are unable to eat and drink normally
- Patients who are unable to validate their understanding of the pain scale
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 |
|---|---|---|
| Telephone-Based InterventionUse PSMA | Behavioural | Health Services Research (PMSA) |
| Questionnaire AdministrationAncillary studies | Other | Health Services Research (PMSA) |
Primary outcome
Compliance characteristics of patients' use of the pain management smartphone application
Time frame: Up to day 50
Summaries of feasibility will be generated using rates (percentages). Descriptive statistics will be used to summarize patient ratings of satisfaction regarding the PMSA, instruction, usage, and future recommendation.
1 secondary outcome
Number of additional OTVs prompted by usage of the application
Time frame: Up to day 50
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 Jul 2016.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Jeffrey Friedman principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based Intervention and Questionnaire Administration in people with Head and Neck Cancer and Pain, run by Vanderbilt-Ingram Cancer Center 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 5 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 Jul 2016. 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?
Compliance characteristics of patients' use of the pain management smartphone application (time frame: Up to day 50). 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 Jul 2016.