Cervical CancerNCT06416150
Reducing Urban Cervical Cancer Disparities
A study testing Stage 1 SOC, Stage 1 HERS and Stage 2 HERS in people with Cervical Cancer and Papilloma Viral Infection, run by Fox Chase Cancer Center at 3 sites in United States.
Trial summary
This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Papilloma Viral Infection
- What is being tested?
- Stage 1 SOC, Stage 1 HERS and Stage 2 HERS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Aug 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 90 years of age (screening is still recommended for some women over 65-depending on screening and medical history and proceeds until age 90 in the study's clinic recruitment sites),
- referral for colposcopic evaluation at the clinic sites,
- able to communicate with ease in English,
- have a cell phone with texting ability, and
- competent to give consent.
Who cannot join
- are pregnant at the time of recruitment,
- display current evidence or have a history of positive invasive carcinoma of the cervix, or
- require follow-up but not a colposcopy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
Shawna Hudson, PhD, (848) 932-0215, hudsonsh@rutgers.edu
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kuang-Yi Wen, PhD, 215-503-4623, kuang-yi.wen@jefferson.edu
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Erin Tagai, PhD, MPH, 215-728-5621, erin.tagai@fccc.edu
Suzanne M Miller, Ph.D.
About this study
Official title: Reducing Urban Cervical Cancer Disparities Using a Tailored MHealth Intervention to Enhance Colposcopy Attendance
This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment.
Read the detailed description
Invasive cervical cancer is preventable with well-established screening and diagnostic tests. However, there is a large and persistent disparity gap in cervical cancer mortality rates among urban, underserved populations that continues to intensify. This gap is largely due to low follow-up after an abnormal test result leading to continued disease risk.
The study team developed an efficacious, tailored telephone counseling intervention delivered by a health coach [Tailored Communication for Cervical Cancer Risk (TC3)] that increased attendance at follow-up appointments for initial colposcopy among urban, underserved women. This evidence-based intervention is available for dissemination and implementation through the National Cancer Institute's Evidence-based Cancer Control Programs database. However, TC3 was developed prior to the upsurge of smartphones and texting usage and is resource-intensive, requiring dedicated staff to interview and counsel patients before their appointment, limiting its scalability and sustainability. Therefore, this study proposes use of a hybrid type 1 effectiveness-implementation study design to assess the impact of a Health Enhancement Resource System (HERS)-adapted from TC3-on attending follow-up appointments after an abnormal cervical test result.
Using a sequential, multiple assignment, randomized trial (SMART) design, a multi-site intervention study will be conducted at three high-volume, urban clinic sites in PA and NJ serving predominately low-income minority women: Fox Chase Cancer Center/Temple University Health System; Rutgers University, and Thomas Jefferson University. The study will target patients scheduled for first time or repeat colposcopy through (a) HERS text message-based barriers counseling and (b) supplemental telephone-based Health Coaching for women who miss their scheduled appointment.
Participants scheduled for a colposcopy after an abnormal cervical test will be recruited and randomized in a 1:1 ratio to receive either Standard of Care or HERS (text message intervention). Participants randomized to Standard of Care who do not attend the scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching).
For the 12-month colposcopy appointment, participants will continue with the last intervention assignment they completed for the first colposcopy appointment (i.e., Standard of Care, HERS, or HERS+HC). Again, participants randomized to Standard of Care who do not attend the 12-month scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the 12-month scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching). Participants randomized to HERS+HC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERS+HC.
All participants will complete surveys at baseline survey and a 1-week post-appointment survey for both colposcopy appointments. Participants will also complete a barriers assessment. Standard of Care participants will complete the assessment via online survey while HERS and HERS+HC participants will complete the barriers assessment via text message as part of the HERS text message intervention.
Qualitative interviews will be completed with providers at each site at pre-implementation and post-implementation. Additionally, a subset of participants will complete exit interviews after their 12-month colposcopy appointment.
- Conditions
- Cervical Cancer, Papilloma Viral Infection
- Being tested
- Stage 1 SOC, Stage 1 HERS, Stage 2 HERS, Stage 2 HERS+HC, Stage 3 SOC
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage 1 SOCBehavioural
Participants will receive high Standard Care, consisting of a telephone call approximately one month before the appointment to confirm the appointment date for the baseline colposcopy appointment, followed by a notification letter including scheduled appointment date and clinic contact information should the clinic be unable to reach the patient by telephone.
Stage 1 HERSBehavioural
Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.
Stage 2 HERSBehavioural
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Stage 2 HERS+HCBehavioural
Participants will receive another barriers assessment and another round of text message barriers counseling as well as health coaching (HC) after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
Stage 3 SOCBehavioural
Participants will receive a telephone call before their 12-month follow-up appointments to remind participants about their upcoming appointment and schedule/reschedule if needed.
Stage 3 HERSBehavioural
Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.
Stage 3 HERS+HCBehavioural
Participants will receive text message barriers counseling as well as HC after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
Stage 4 HERSBehavioural
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Stage 4 HERS+HCBehavioural
Participants will receive another barriers assessment and another round of text message barriers counseling as well as HC. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 and 3 SoC | Experimental | Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient attends 12-month follow-up appointment, no Stage 4 intervention. Receives: Behavioral: Stage 1 SOC; Behavioral: Stage 3 SOC |
| Stage 1 and 3 SoC + Stage 4 HERS | Experimental | Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Receives: Behavioral: Stage 1 SOC; Behavioral: Stage 3 SOC; Behavioral: Stage 4 HERS |
| Stage 1 SoC + Stage 2 and 3 HERS | Experimental | Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Receives: Behavioral: Stage 1 SOC; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS |
| Stage 1 SoC + Stage 2, 3, and 4 HERS | Experimental | Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Receives: Behavioral: Stage 1 SOC; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS |
| Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC | Experimental | Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Receives: Behavioral: Stage 1 SOC; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS+HC |
| Stage 1 and 3 HERS | Experimental | Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 3 HERS |
| Stage 1, 3, and 4 HERS | Experimental | Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS |
| Stage 1 and 3 HERS + Stage 4 HERS+HC | Experimental | Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS+HC |
| Stage 1, 2, and 3 HERS | Experimental | Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS |
| Stage 1, 2, 3, and 4 HERS | Experimental | Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS |
| Stage, 2, and 3 HERS + Stage 4 HERS+HC | Experimental | Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS+HC |
| Stage 1 HERS + Stage 2 and 3 HERS+HC | Experimental | Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS+HC; Behavioral: Stage 3 HERS+HC |
| Stage 1 HERS + Stage 2, 3, and 4 HERS+HC | Experimental | Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Receives: Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS+HC; Behavioral: Stage 3 HERS+HC; Behavioral: Stage 4 HERS+HC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at baseline colposcopy appointment
Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records
Measured: Up to 3 months post-baseline
Secondary outcomes (1)
Attendance at 12-month follow-up appointment
Patient attendance or non-attendance at 12-month follow-up appointment assessed via appointment attendance history in electronic medical records
Measured: Up to 15 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start28 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey, Thomas Jefferson University, Temple University, University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Suzanne M Miller, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416150
- Sponsor's protocol ID
- 23-1035
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is essential to increase reproducibility and transparency of research and the translation of research findings into practice, leading to improved health outcomes. Data generated from the proposed study will be shared with the research community through presentations at scientific meetings and publications in peer-reviewed journals. Further, data will be available to qualified researchers after the main findings are published in a peer-reviewed journal. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Urban Cervical Cancer Disparities Using a Tailored MHealth Intervention to Enhance Colposcopy Attendance
- ClinicalTrials.gov ID
- NCT06416150
- Acronym / sponsor ID
- 23-1035
- Conditions
- Cervical Cancer, Papilloma Viral Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey, Thomas Jefferson University, Temple University, University of South Carolina
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment.
Detailed description
Invasive cervical cancer is preventable with well-established screening and diagnostic tests. However, there is a large and persistent disparity gap in cervical cancer mortality rates among urban, underserved populations that continues to intensify. This gap is largely due to low follow-up after an abnormal test result leading to continued disease risk.
The study team developed an efficacious, tailored telephone counseling intervention delivered by a health coach [Tailored Communication for Cervical Cancer Risk (TC3)] that increased attendance at follow-up appointments for initial colposcopy among urban, underserved women. This evidence-based intervention is available for dissemination and implementation through the National Cancer Institute's Evidence-based Cancer Control Programs database. However, TC3 was developed prior to the upsurge of smartphones and texting usage and is resource-intensive, requiring dedicated staff to interview and counsel patients before their appointment, limiting its scalability and sustainability. Therefore, this study proposes use of a hybrid type 1 effectiveness-implementation study design to assess the impact of a Health Enhancement Resource System (HERS)-adapted from TC3-on attending follow-up appointments after an abnormal cervical test result.
Using a sequential, multiple assignment, randomized trial (SMART) design, a multi-site intervention study will be conducted at three high-volume, urban clinic sites in PA and NJ serving predominately low-income minority women: Fox Chase Cancer Center/Temple University Health System; Rutgers University, and Thomas Jefferson University. The study will target patients scheduled for first time or repeat colposcopy through (a) HERS text message-based barriers counseling and (b) supplemental telephone-based Health Coaching for women who miss their scheduled appointment.
Participants scheduled for a colposcopy after an abnormal cervical test will be recruited and randomized in a 1:1 ratio to receive either Standard of Care or HERS (text message intervention). Participants randomized to Standard of Care who do not attend the scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching).
For the 12-month colposcopy appointment, participants will continue with the last intervention assignment they completed for the first colposcopy appointment (i.e., Standard of Care, HERS, or HERS+HC). Again, participants randomized to Standard of Care who do not attend the 12-month scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the 12-month scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching). Participants randomized to HERS+HC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERS+HC.
All participants will complete surveys at baseline survey and a 1-week post-appointment survey for both colposcopy appointments. Participants will also complete a barriers assessment. Standard of Care participants will complete the assessment via online survey while HERS and HERS+HC participants will complete the barriers assessment via text message as part of the HERS text message intervention.
Qualitative interviews will be completed with providers at each site at pre-implementation and post-implementation. Additionally, a subset of participants will complete exit interviews after their 12-month colposcopy appointment.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Stage 1 and 3 SoC | Experimental | Behavioral: Stage 1 SOC, Behavioral: Stage 3 SOCStart with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient attends 12-month follow-up appointment, no Stage 4 intervention. |
| Stage 1 and 3 SoC + Stage 4 HERS | Experimental | Behavioral: Stage 1 SOC, Behavioral: Stage 3 SOC, Behavioral: Stage 4 HERSStart with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. |
| Stage 1 SoC + Stage 2 and 3 HERS | Experimental | Behavioral: Stage 1 SOC, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERSStart with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. |
| Stage 1 SoC + Stage 2, 3, and 4 HERS | Experimental | Behavioral: Stage 1 SOC, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERSStart with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. |
| Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC | Experimental | Behavioral: Stage 1 SOC, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERS+HCStart with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. |
| Stage 1 and 3 HERS | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 3 HERSStart with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. |
| Stage 1, 3, and 4 HERS | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERSStart with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. |
| Stage 1 and 3 HERS + Stage 4 HERS+HC | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERS+HCStart with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. |
| Stage 1, 2, and 3 HERS | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERSStart with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. |
| Stage 1, 2, 3, and 4 HERS | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERSStart with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. |
| Stage, 2, and 3 HERS + Stage 4 HERS+HC | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 2 HERS, Behavioral: Stage 3 HERS, Behavioral: Stage 4 HERS+HCStart with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. |
| Stage 1 HERS + Stage 2 and 3 HERS+HC | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 2 HERS+HC, Behavioral: Stage 3 HERS+HCStart with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention. |
| Stage 1 HERS + Stage 2, 3, and 4 HERS+HC | Experimental | Behavioral: Stage 1 HERS, Behavioral: Stage 2 HERS+HC, Behavioral: Stage 3 HERS+HC, Behavioral: Stage 4 HERS+HCStart with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 90 years of age (screening is still recommended for some women over 65-depending on screening and medical history and proceeds until age 90 in the study's clinic recruitment sites),
- referral for colposcopic evaluation at the clinic sites,
- able to communicate with ease in English,
- have a cell phone with texting ability, and
- competent to give consent.
Key exclusion criteria (3 listed)
- are pregnant at the time of recruitment,
- display current evidence or have a history of positive invasive carcinoma of the cervix, or
- require follow-up but not a colposcopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage 1 SOCParticipants will receive high Standard Care, consisting of a telephone call approximately one month before the appointment to confirm the appointment date for the baseline colposcopy appointment, followed by a notification letter including scheduled appointment date and clinic contact information should the clinic be unable to reach the patient by telephone. | Behavioural | Stage 1 SoC + Stage 2 and 3 HERS, Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC, Stage 1 SoC + Stage 2, 3, and 4 HERS, Stage 1 and 3 SoC, Stage 1 and 3 SoC + Stage 4 HERS |
| Stage 1 HERSParticipants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment. | Behavioural | Stage 1 HERS + Stage 2 and 3 HERS+HC, Stage 1 HERS + Stage 2, 3, and 4 HERS+HC, Stage 1 and 3 HERS, Stage 1 and 3 HERS + Stage 4 HERS+HC, Stage 1, 2, 3, and 4 HERS, Stage 1, 2, and 3 HERS, Stage 1, 3, and 4 HERS, Stage, 2, and 3 HERS + Stage 4 HERS+HC |
| Stage 2 HERSParticipants will receive another barriers assessment and another round of text message appointment reminders and barriers messages. | Behavioural | Stage 1 SoC + Stage 2 and 3 HERS, Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC, Stage 1 SoC + Stage 2, 3, and 4 HERS, Stage 1, 2, 3, and 4 HERS, Stage 1, 2, and 3 HERS, Stage, 2, and 3 HERS + Stage 4 HERS+HC |
| Stage 2 HERS+HCParticipants will receive another barriers assessment and another round of text message barriers counseling as well as health coaching (HC) after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. | Behavioural | Stage 1 HERS + Stage 2 and 3 HERS+HC, Stage 1 HERS + Stage 2, 3, and 4 HERS+HC |
| Stage 3 SOCParticipants will receive a telephone call before their 12-month follow-up appointments to remind participants about their upcoming appointment and schedule/reschedule if needed. | Behavioural | Stage 1 and 3 SoC, Stage 1 and 3 SoC + Stage 4 HERS |
| Stage 3 HERSParticipants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment. | Behavioural | Stage 1 SoC + Stage 2 and 3 HERS, Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC, Stage 1 SoC + Stage 2, 3, and 4 HERS, Stage 1 and 3 HERS, Stage 1 and 3 HERS + Stage 4 HERS+HC, Stage 1, 2, 3, and 4 HERS, Stage 1, 2, and 3 HERS, Stage 1, 3, and 4 HERS, Stage, 2, and 3 HERS + Stage 4 HERS+HC |
| Stage 3 HERS+HCParticipants will receive text message barriers counseling as well as HC after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. | Behavioural | Stage 1 HERS + Stage 2 and 3 HERS+HC, Stage 1 HERS + Stage 2, 3, and 4 HERS+HC |
| Stage 4 HERSParticipants will receive another barriers assessment and another round of text message appointment reminders and barriers messages. | Behavioural | Stage 1 SoC + Stage 2, 3, and 4 HERS, Stage 1 and 3 SoC + Stage 4 HERS, Stage 1, 2, 3, and 4 HERS, Stage 1, 3, and 4 HERS |
| Stage 4 HERS+HCParticipants will receive another barriers assessment and another round of text message barriers counseling as well as HC. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less. | Behavioural | Stage 1 HERS + Stage 2, 3, and 4 HERS+HC, Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC, Stage 1 and 3 HERS + Stage 4 HERS+HC, Stage, 2, and 3 HERS + Stage 4 HERS+HC |
Primary outcome
Attendance at baseline colposcopy appointment
Time frame: Up to 3 months post-baseline
Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records
1 secondary outcome
Attendance at 12-month follow-up appointment
Time frame: Up to 15 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Yes. Data sharing is essential to increase reproducibility and transparency of research and the translation of research findings into practice, leading to improved health outcomes. Data generated from the proposed study will be shared with the research community through presentations at scientific meetings and publications in peer-reviewed journals. Further, data will be available to qualified researchers after the main findings are published in a peer-reviewed journal. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne M Miller, PhD principal investigator
Fox Chase Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stage 1 SOC, Stage 1 HERS and Stage 2 HERS in people with Cervical Cancer and Papilloma Viral Infection, run by Fox Chase Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne M Miller, PhD (215-728-4069, suzanne.miller@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at baseline colposcopy appointment (time frame: Up to 3 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.