Stories to Prevent (StoP) HPV Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cancer survivor narrative, Healthy eating tips.
- Who it may be relevant to
- Registry conditions: Human Papillomavirus Vaccination, Emotions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.
Overview
This randomized controlled trial (RCT) evaluates the association of a narrative communication intervention on human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds. The intervention is a brief video from local cancer survivors narrating their stories with an HPV-related cancer diagnosis and recommending the HPV vaccine for cancer prevention. RCT participants will be the parents (n=200) of children ages 9-12 who have not initiated HPV vaccination. Participants will be randomized (1:1) to our intervention or control (placebo video) one week before their child's next primary care visit. Our primary outcome is HPV vaccine initiation (first dose of the HPV vaccine series) among children ages 9-12 at the time of the wellness visit. The study also explores the effect of narratives on theory-based mediators of HPV vaccination, including parents' cognitive (e.g., risk perception) and emotional reactions (e.g., hope, anticipated regret).
Detailed description
Despite the availability of the human papillomavirus (HPV) vaccine that can prevent over 37,300 HPV-related cancers in the US every year, only 62.6% of girls and boys were up-to-date in 2022. Low-quality provider recommendations and time constraints during clinic visits limit parents' opportunities to discuss and make HPV vaccination decisions. Pre-visit education to parents could complement provider communication to promote HPV vaccination. There is a critical need to identify better communication strategies to increase HPV vaccine uptake, including the use of narrative messaging and existing digital technologies in clinics and at home (electronic health records, patient portal, mobile devices). The Stories to Prevent (StoP) HPV Cancers Study is a randomized controlled trial (RCT) to evaluate the association of a narrative communication intervention delivered through digital and mobile technology before clinic visits on HPV vaccine initiation rates. A sample of 200 parents of unvaccinated children ages 9-12 will be randomized to receive our intervention or control (placebo video). Participants will be recruited from general pediatric and family medicine clinics affiliated with Penn State Health. We will also examine the effect of narrative communication on theory-based psychological mediators of HPV vaccine initiation and narrative communication processes, specifically parents' cognitive and emotional reactions.
Interventions
- Other Cancer survivor narrative
The narrative video intervention has three parts: (1) Cancer experience - the cancer survivor narrates his/her experience with an HPV-related cancer, including diagnosis, treatment, and how cancer affected their personal life or family; (2) Vaccine recommendation - the cancer survivor provides brief information about the safety and effectiveness of the HPV vaccine and recommend that parents get the HPV vaccine for their child to prevent cancers; and (3) Closing message - The sentence "HPV vaccin - Other Healthy eating tips
A publicly available video about healthy eating tips for families with children.
Primary outcome measures
- HPV vaccine initiation, 9-12 year olds [Time frame: One week after clinic visit]
Secondary outcome measures (10)
- HPV vaccine initiation stratified by age [Time frame: One week after clinic visit]
- HPV vaccine initiation stratified by sex [Time frame: One week after clinic visit]
- HPV vaccine initiation stratified by race/ethnicity [Time frame: One week after clinic visit]
- HPV vaccine communication in clinics [Time frame: One week after clinic visit]
- Believability [Time frame: One week after the intervention]
- Character identification [Time frame: One week after the intervention]
- Health beliefs [Time frame: One week after the intervention]
- Positive affect [Time frame: One week after the intervention]
- Negative affect [Time frame: One week after the intervention]
- Acceptability of digital health interventions [Time frame: One week after the intervention]
Eligibility criteria
Inclusion criteria
- Parent/guardian of a 9-12 year old receiving primary care at a Penn State Health clinic
- Their child has not previously received or initiated the HPV vaccine
- Is able to read and understand spoken English or Spanish
- Has a valid email address and access to a mobile phone, table, desktop or laptop computer to engage in the intervention
Exclusion criteria
- Parent of guardian is less than 18 years of age
- Unable to read and understand spoken English or Spanish
- Does not have access to a mobile phone, table, desktop or laptop computer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Penn State Health — Hershey
Identifiers
NCT: NCT06808776 · STUDY00025798