NCT03707860

Brief 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 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..)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

October 12, 2018

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Grade of symptoms improved with early intervention.

    using CTCAE v.5

    only during RT (7WEEKS)

Secondary Outcomes (1)

  • compliance on the mobile.

    Only during RT (7WEEKS)

Study Arms (1)

head and neck radiotherapy patients

(Single arm); Patients receiving radiotherapy for head and neck cancers can report their symptoms through the mobile app.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred to our radiation oncology clinic with head and neck cancer.

You may qualify if:

  • Adult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone

You may not qualify if:

  • Poor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsWounds and Injuries
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Radiation Oncology

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

February 1, 2019

Primary Completion

October 20, 2021

Study Completion

October 20, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations