HPV-related cervical abnormalities
Conditions
Interventions
None listed
Sponsors
MSD K.K.
DeSC Healthcare, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: For HPV related diseases (cervical abnormalities) group: -Participants who answered they has visited hospital/clinic for self-reported HPV related cervical abnormalities within the past 6 months at the screening -Participants who had HPV-related cervical abnormalities defined by ICD-10 diagnosis codes For Non HPV related diseases group: -Participants who answered not visit hospital/clinic for HPV related cervical related abnormalities within the past 6 months at the screening -Participants who answered they received the cervical cancer screening with normal result within the past 6 months at the screening -Participants who self-reported other than positive results (negative, don't remember/unknown and no test) in the HPV infectious test within the past 6 months at screening -Participants who had no treatment/diagnosis of HPV-related cervical abnormalities by the ICD 10 diagnosis/medical compensation codes within 6 months For HPV infection group: -Participants who self-reported no HPV related cervical abnormalities within the past 6 months at the screening -Participants who answered not visit hospital/clinic for HPV-related cervical related abnormalities within the past 6 months at the screening -Participants who self-reported positive results in the HPV infectious test values within the past 6 months at screening -Participants who had no treatment/diagnosis of HPV related cervical abnormalities by the ICD-10 diagnosis/medical compensation codes within 6 months
Exclusion criteria
Exclusion criteria: Women identified by screening questions; -Women who received any type of HPV vaccine in the past -Women who did not know the status of HPV vaccination -Pregnant women -Women with abnormal and unknown results for cervical cancer screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Human Papillomavirus Impact Profile (HIP) Human Papillomavirus Impact Profile (HIP) is a validated, self-administered questionnaire, designed to measure the psychosocial impact of HPV-related health conditions in women. This is 29-item rated on a 0 (no impact) -10 point (worst impact) discretized visual analog scale grouped into seven hypothesized domains: Worries and concerns, Emotional impact, Sexual impact, Self-image, Partner issues and transmission, Interactions with doctors, and Control-life impact . Dimension scores and a total burden score, all ranging from 0 to 100, are calculated based on item scores. Higher scores indicate a greater psychosocial impact of HPV. The Japanese version of the HIP questionnaire was generated through a standard linguistic validation process, which included translation, back translation, comparison, review and consolidation and field pilot testing by MAPI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Kessler Psychological Distress Scale 6 (K6) The Kessler 6 Psychological Distress Scale (K6) is a brief 6-item questionnaire designed to measure the level of distress and severity associated with psychological symptoms in population surveys. The K6 is one of the most commonly and extensively used self-report tools as a clinical outcome measure across the world. The Japanese version of the K6 has already been developed and demonstrated screening performances essentially equivalent to those of the original English versions. K6 psychological distress includes the following items: (1) so sad nothing can cheer up, (2) nervous, (3) restless or fidgety, (4) hopeless, (5) everything was an effort, and (6) worthless. K6 can be scored using the unweighted sum of responses; 1 all of the time, 2 most of the time, 3 some of the time, 4 a little of the time, 5 none of the time. Thus, the total scores range from 0 to 24; K6 score of 0 to 7 indicates low distress, 8 to 12 moderate distress, and 13 to 24 high risk of psychological distress. Previous study using K6 described that a positive outcome of cervical cancer screening was associated with psychological distress in Japan. | — |
Countries
Japan
Contacts
Public ContactYukari Ohta
MSD K.K. Medical Affairs
Outcome results
None listed