Back to resultsMobile Phone Technology to Increase Genetic Counseling (mAGIC)
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mAGIC app
Sponsored by
About this trial
This is an interventional health services research trial for Ovarian Cancer
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- Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
Sites / Locations
- University of Minnesota Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Receive 7-day mAGIC app intervention and handout
Handout only
Outcomes
Primary Outcome Measures
Uptake of cancer genetic counseling
Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02877862
Brief Title
Mobile Phone Technology to Increase Genetic Counseling
Acronym
mAGIC
Official Title
Mobile Phone Technology to Increase Genetic Counseling for Women With Ovarian Cancer and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive 7-day mAGIC app intervention and handout
Arm Title
Control
Arm Type
No Intervention
Arm Description
Handout only
Intervention Type
Behavioral
Intervention Name(s)
mAGIC app
Intervention Description
7-day app to encourage uptake of genetic counseling
Primary Outcome Measure Information:
Title
Uptake of cancer genetic counseling
Description
Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Geller, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30718125
Citation
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.
Results Reference
derived
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Mobile Phone Technology to Increase Genetic Counseling
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