Head and Neck Cancerγ-AppNCT03707860
Radiation Oncology Mobile Application
An observational study of Head and Neck Cancer and Radiation Toxicity, run by King Hussein Cancer Center at 1 site in Jordan.
Trial summary
To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer, Radiation Toxicity
- How many people
- 0 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2019to 20 Oct 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to our radiation oncology clinic with head and neck cancer.
Who may be able to join
- Adult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone
Who cannot join
- Poor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation Oncology Mobile Application: Symptoms Reporting System and Quality Assurance Tool
To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule.
In addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks.
Furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)
- Conditions
- Head and Neck Cancer, Radiation Toxicity
- Medical subject headings
- Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| head and neck radiotherapy patients | (Single arm); Patients receiving radiotherapy for head and neck cancers can report their symptoms through the mobile app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of symptoms improved with early intervention.
using CTCAE v.5
Measured: only during RT (7WEEKS)
Secondary outcomes (1)
compliance on the mobile.
number of reports.
Measured: Only during RT (7WEEKS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Feb 2019
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Why it stopped: the program couldn't be implemented
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramiz Abu-Hijlih, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707860
- Sponsor's protocol ID
- 18 KHCC 86
- Acronym
- γ-App
- Status last verified
- May 2022
- First submitted
- 12 Oct 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Oncology Mobile Application: Symptoms Reporting System and Quality Assurance Tool
- ClinicalTrials.gov ID
- NCT03707860
- Acronym / sponsor ID
- γ-App / 18 KHCC 86
- Conditions
- Head and Neck Cancer, Radiation Toxicity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the program couldn't be implemented
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 16 Oct 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.
To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule.
In addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks.
Furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head and neck radiotherapy patients | – | –(Single arm); Patients receiving radiotherapy for head and neck cancers can report their symptoms through the mobile app. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to our radiation oncology clinic with head and neck cancer.
Key inclusion criteria (1 listed)
- Adult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone
Key exclusion criteria (1 listed)
- Poor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade of symptoms improved with early intervention.
Time frame: only during RT (7WEEKS)
using CTCAE v.5
1 secondary outcome
compliance on the mobile.
Time frame: Only during RT (7WEEKS)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Radiation Toxicity, run by King Hussein Cancer Center at 1 site in Jordan.
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: withdrawn, as of the sponsor's last update on 27 May 2022. 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 Jordan. 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 was withdrawn before enrolling participants, so there are no results.
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?
Grade of symptoms improved with early intervention. (time frame: only during RT (7WEEKS)). 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 27 May 2022.