Radiation Oncology Mobile Application | NCT03707860

Studies
Radiation Oncology Mobile Application

NCT03707860

Sponsor

King Hussein Cancer Center

Status

Withdrawn

Last Update Posted

May 27, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Head and Neck Cancer
Radiation Toxicity

Interventions

Not provided

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the program couldn't be implemented

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Oct 20, 2021Actual

Completion Date

Oct 20, 2021Actual

First Submitted Date

Oct 12, 2018

First Submission Date that Met QC Criteria

Oct 12, 2018

First Posted Date

Oct 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2022

Last Update Posted Date

May 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
head and neck radiotherapy patients		(Single arm); Patients receiving radiotherapy for head and neck cancers can report their symptoms through the mobile app.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Grade of symptoms improved with early intervention.	using CTCAE v.5	only during RT (7WEEKS)

Secondary Outcomes

Measure	Description	Time Frame
compliance on the mobile.	number of reports.	Only during RT (7WEEKS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Hussein Cancer Center		Amman		11941	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D011832	Radiation Injuries

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided