Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346915
• Other study ID #: H-36669
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: April 19, 2019

Study information

• Verified date: October 2019
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to increase HPV vaccination and cervical cancer screening through a web-based mobile health education program called, Wheel of Wellness (WoW) and a brief negotiated interview (BNI). The in-person BNI and WoW system will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening.

Description:

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 researchers will conduct a single armed proof of concept where the participants will be actively using WoW. The in-person BNI will empower participants to have positive behavioral changes in regards to their health by giving them appropriate health information as well as answering their questions and concerns about cervical cancer prevention and screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Parent/guardian with a child between the ages of 9 to 17 who receives primary care at one of the participating sites and their male child.

2. Parent/guardian with a male child who provides consent to have child's HPV vaccination status checked in EMR.

3. Parent/guardian with a male child who has neither initiated the HPV vaccine nor completed the series

4. Parent/guardian and male child with the ability to read and write in English.

5. Parent/guardian and male child have access to a smartphone.

Exclusion Criteria:

1. Parent/guardian's eligible child is pregnant.

2. Parent/guardian's has begun or completed the HPV series.

3. Parent/guardian, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Cervical Cancer
• Human Papilloma Virus
• Human Papillomavirus Infection
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Papilloma
• Papillomavirus Infections
• Penile Cancer
• Penile Neoplasms
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccine series start and completion	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.	6 months
Secondary	HPV and Cervical Cancer awareness and knowledge	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.	6-12 months
Secondary	Provider-patient communication about HPV vaccine and cervical cancer	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.	one week after provider visit throughout the duration of the study
Secondary	Wheel of Wellness (WoW) feasibility	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.	6 months
Secondary	Wheel of Wellness (WoW) feasibility	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.	12 months