Ovarian CancermAGICNCT02877862
Mobile Phone Technology to Increase Genetic Counseling
A study testing mAGIC app in people with Ovarian Cancer, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- mAGIC app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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- Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Known major psychiatric or neurological diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Mobile Phone Technology to Increase Genetic Counseling for Women With Ovarian Cancer and Their Families
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
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- mAGIC app
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mAGIC appBehavioural
7-day app to encourage uptake of genetic counseling
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive 7-day mAGIC app intervention and handout Receives: Behavioral: mAGIC app |
| Control | No intervention | Handout only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of cancer genetic counseling
Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Geller, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877862
- Sponsor's protocol ID
- MCC
- Acronym
- mAGIC
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30718125
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Technology to Increase Genetic Counseling for Women With Ovarian Cancer and Their Families
- ClinicalTrials.gov ID
- NCT02877862
- Acronym / sponsor ID
- mAGIC / MCC
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: mAGIC appReceive 7-day mAGIC app intervention and handout |
| Control | No intervention | –Handout only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Known major psychiatric or neurological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mAGIC app7-day app to encourage uptake of genetic counseling | Behavioural | Intervention |
Primary outcome
Uptake of cancer genetic counseling
Time frame: 3 months
Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 30718125Vogel 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.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Geller, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mAGIC app in people with Ovarian Cancer, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of cancer genetic counseling (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.