Clinical trial NCT03876665: The Experience of Living With Polycystic Ovary Syndrome in the Military
Official title: The Experience of Living With Polycystic Ovary Syndrome in the Military
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Military
Service Women
Active Duty
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
Collaborators: name: Madigan Army Medical Center
name: United States Naval Medical Center, San Diego
name: Malcolm Grow Medical Clinics and Surgery Center
First posted: 2019-03-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty military women diagnosed with PCOS

Brief summary: The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.

Detailed description: Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest \[64, 65\].

This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.

Eligibility criteria: Inclusion Criteria:

* Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
* Diagnosed with PCOS
* 18 years of age or over

Exclusion Criteria:

* Reservist, Coast Guard, women who have separated or retired \> 5 years ago

Primary outcomes:
measure: Describe the PCOS experience of active duty service members
timeFrame: through study completion, up to 18 months
measure: Describe the PCOS experience by branch of service
timeFrame: through study completion, up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: Dawnkimberly Hopkins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Madigan Army Medical Center
name: Leilani Siaki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: United States Naval Medical Center, San Diego
name: Abigail Yablonsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malcolm Grow Medical Clinics and Surgery Center
name: Angela Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.
citation: Yildizhan B, Anik Ilhan G, Pekin T. The impact of insulin resistance on clinical, hormonal and metabolic parameters in lean women with polycystic ovary syndrome. J Obstet Gynaecol. 2016 Oct;36(7):893-896. doi: 10.3109/01443615.2016.1168376. Epub 2016 May 3.
citation: Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
citation: Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.