NCT02877862

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 24, 2016

Last Update Submit

March 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Receive 7-day mAGIC app intervention and handout

Behavioral: mAGIC app

Control

NO INTERVENTION

Handout only

Interventions

mAGIC appBEHAVIORAL

7-day app to encourage uptake of genetic counseling

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
  • 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.

You may not qualify if:

  • Known major psychiatric or neurological diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Melissa Geller, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

August 24, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations