Cervical CancerNCT01525433
Cervical Cancer Screening Among Hispanic Women
A study testing DVD and Promotora in people with Cervical Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
In this study, 400 Hispanic women will be recruited and randomized to one of three interventions: 1. Control (no change); 2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; 3. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- DVD and Promotora
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 17 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 21 - 64 years of age
- Hispanic or Latina
- Resident of the Yakima Valley, WA, USA
- No hysterectomy
- Last PAP test (cervical screening) more than 3 years ago
- Last seen at the local clinic less than 5 years ago
Who cannot join
- Less than 21 or greater than 64 years of age
- PAP test less 3 years ago
- Prior hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:
- Control (no change);
- A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
- A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.
The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)
- Conditions
- Cervical Cancer
- Being tested
- DVD, Promotora
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVDBehavioural
Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening
PromotoraBehavioural
Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Low Intensity Information (DVD) | Active comparator | A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; Receives: Behavioral: DVD |
| High Intensity Information (Promotora) | Active comparator | A higher intensity information program consisting of the video plus a 'promotora' or lay-community health educator led-intervention at the participant's home to encourage cervical cancer screening. Receives: Behavioral: Promotora |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant attends cervical cancer screening
Measured: Within 7 months of the intervention
Secondary outcomes (1)
Patient Navigator
Evaluation of the patient navigator program as a method to improve adherence and reduce time to follow-up among study participants who receive an abnormal Pap test result. Time to follow-up will be compared to a similar population of patients who were not part of the study who also receive a diagnosis of an abnormal Pap test.
Measured: Elapsed time from diagnosis to clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2015
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Beti Thompson, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525433
- Sponsor's protocol ID
- FHCRC IR 7290
- Other IDs
- U54CA153502
- Status last verified
- Nov 2018
- First submitted
- 31 Jan 2012
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.
PubMed 22559251
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
- ClinicalTrials.gov ID
- NCT01525433
- Acronym / sponsor ID
- FHCRC IR 7290
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 3 Feb 2012 (estimated)
- 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.
In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:
- Control (no change);
- A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
- A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.
The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Low Intensity Information (DVD) | Active comparator | Behavioral: DVDA low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; |
| High Intensity Information (Promotora) | Active comparator | Behavioral: PromotoraA higher intensity information program consisting of the video plus a 'promotora' or lay-community health educator led-intervention at the participant's home to encourage cervical cancer screening. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- 21 - 64 years of age
- Hispanic or Latina
- Resident of the Yakima Valley, WA, USA
- No hysterectomy
Key exclusion criteria (3 listed)
- Less than 21 or greater than 64 years of age
- PAP test less 3 years ago
- Prior hysterectomy
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 |
|---|---|---|
| DVDParticipants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening | Behavioural | Low Intensity Information (DVD) |
| PromotoraParticipants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening | Behavioural | High Intensity Information (Promotora) |
Primary outcome
Participant attends cervical cancer screening
Time frame: Within 7 months of the intervention
1 secondary outcome
Patient Navigator
Time frame: Elapsed time from diagnosis to clinic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Derived from this study: PubMed 22559251Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.
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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. This study is not recruiting at the moment.
Beti Thompson, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD and Promotora in people with Cervical Cancer, run by Fred Hutchinson Cancer Center at 1 site 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 7 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: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant attends cervical cancer screening (time frame: Within 7 months of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525433, which also lists 1 linked publication.
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 13 Nov 2018.