Mobile Phone Technology to Increase Genetic Counseling | NCT02877862

Studies
Mobile Phone Technology to Increase Genetic Counseling

NCT02877862

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Mar 27, 2018Actual

Enrollment

104Actual

Phase

Not Applicable

Conditions

Ovarian Cancer

Interventions

mAGIC app

Countries

United States

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Mar 24, 2016

First Submission Date that Met QC Criteria

Aug 19, 2016

First Posted Date

Aug 24, 2016Estimated

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

Mar 23, 2018

Last Update Posted Date

Mar 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This innovative project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model, developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective is to develop and assess the feasibility and effectiveness of a theory-based intervention aimed to encourage ovarian cancer survivors to receive genetic counseling

Detailed Description

This project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model31 (FBM), developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) week-long intervention to motivate ovarian cancer survivors to undergo genetic counseling.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Receive 7-day mAGIC app intervention and handout	Behavioral: mAGIC app
Control	No Intervention	Handout only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mAGIC app	Behavioral	7-day app to encourage uptake of genetic counseling	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uptake of cancer genetic counseling	Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
18 years old or older
At least a fifth grade education
Able to read and write in English
Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

• Known major psychiatric or neurological diagnosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa Geller, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Medical Center		Minneapolis	Minnesota	55455	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30718125	Derived	Vogel RI, Niendorf K, Petzel S, Lee H, Teoh D, Blaes AH, Argenta P, Rivard C, Winterhoff B, Lee HY, Geller MA. A patient-centered mobile health application to motivate use of genetic counseling among women with ovarian cancer: A pilot randomized controlled trial. Gynecol Oncol. 2019 Apr;153(1):100-107. doi: 10.1016/j.ygyno.2019.01.019. Epub 2019 Feb 1.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases