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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 : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Brief 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.

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

Detailed 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.

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)
Primary Purpose: Prevention
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 : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   9 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Natalie Joseph, MD, MPH 7818794841 napierre@bu.edu
Contact: Maria De Ornelas, BS 3059511119 marisol0@bu.edu

Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Natalie Joseph, MD, MPH Boston Medical Center

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03346915     History of Changes
Other Study ID Numbers: H-36669
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:
HPV vaccinaton
Cervical cancer screening
Web-based mobile health education
brief negotiated interview (BNI

Additional relevant MeSH terms:
Anus Diseases
Uterine Cervical Neoplasms
Papilloma
Anus Neoplasms
Oropharyngeal Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Papillomavirus Infections
Penile Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms