Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention
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|ClinicalTrials.gov Identifier: NCT03346915|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus Cervical Cancer Human Papillomavirus Infection Oropharyngeal Cancer Vaginal Cancer Vulvar Cancer Anal Cancer Penile Cancer||Behavioral: WoW and BNI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
We are proposing a single arm proof of concept. We will recruit 30 parents/guardians and their age-eligible child for the single arm proof of concept.
For this proof of concept/pilot trial, we will assess the feasibility and impact of WOW to improve provider communication about HPV vaccination and increase the initial and complete vaccination rates for both boys and girls aged 9-17 and to enhance knowledge and awareness about risks and benefits of HPV vaccine among dyads. The power of our proposed pilot for determining intervention effects is limited. However, because we are proposing a proof of concept pilot and feasibility study, in our experience and that of others, our proposed sample size generally provides sufficient data to estimate subject retention, distribution of variables and feasibility as we plan for a larger-multi-site RCT of the proposed study. We expect our intervention to demonstrate feasibility of the intervention in a clinic setting.
|Masking:||None (Open Label)|
|Official Title:||Integrating a Health Information Technology System With a Web-based Mobile Health Educational Intervention to Support More Effective Provider-patient Communication and HPV Vaccine Utilization|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Subjects receiving WoW and BNI
The behavioral intervention (WoW and BNI) will supplement the subject's standard of care by incorporating interactive messaging, reminders, patient education, and enhanced provider communication.
Behavioral: WoW and BNI
The Text/web based health information technology system, WoW, will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening. WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The brief negotiated interview will encourage and empower participants to have positive behavioral changes in regards to their health.
- HPV vaccine series start and completion [ Time Frame: 6 months ]The primary outcome of interest is receipt of the first dose and completion of the three-dose or two-dose series of HPV vaccine by participants within six months of intervention by EMR review.
- HPV and Cervical Cancer awareness and knowledge [ Time Frame: 6-12 months ]Change in knowledge of HPV vaccination and cervical cancer will be measured using a survey, which is under development, that includes questions about HPV and HPV vaccination. It will be administered before and again after the intervention and changes in responses will be compared.
- Provider-patient communication about HPV vaccine and cervical cancer [ Time Frame: one week after provider visit throughout the duration of the study ]Based on participants' entries onto the WoW website, a list of their concerns and questions about HPV vaccine and cervical cancer will be created and this list will be brought to a clinical visit with their providers. Following the clinical visit, participants will be asked whether providers addressed their questions and concerns about HPV vaccine and cervical cancer using a short questionnaire with a 5 point likert scale where 1=completely addressed and 5= not at all addressed. Lower scores are favorable.
- Wheel of Wellness (WoW) feasibility [ Time Frame: 6 months ]The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.
- Wheel of Wellness (WoW) feasibility [ Time Frame: 12 months ]The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346915
|Contact: Natalie Joseph, MD, MPHfirstname.lastname@example.org|
|Contact: Maria De Ornelas, BSemail@example.com|
|Principal Investigator:||Natalie Joseph, MD, MPH||Boston Medical Center|