Breast CancerCLSNCT04617236
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
A study testing Cultivando La Salud in people with Breast Cancer and Cervical Cancer, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Cultivando La Salud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 15 May 2012to 2 Jul 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 21 and older for Pap cohort
- Women aged 40 and older for Mammography cohort
Who cannot join
- Having completed a Papanicolau test in the past 3 years if participant is between the ages of 21-65.
- Having completed a Mammography screening in the past year if participant is aged 40 or older
- Have a hysterectomy
- Currently pregnant
- History of any type of cancer
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus
San Juan, 00984
About this study
The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in Canóvanas, Puerto Rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. To evaluate promotoras' delivery of the CLS screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the CLS intervention program compared with usual practice (no intervention).
Read the detailed description
The proposed promotora and community based breast and cervical screening education program includes the following specific aims:
Aim 1. To train community health workers (promotoras) from Taller Salud to implement the CLS breast and cervical cancer screening program. Taller Salud staff train and build capacity of promotoras to implement the CLS community-based education and navigation program.
Aim 2. To deliver the CLS intervention program to at least 600 women in Canóvanas municipality, Puerto Rico.
Aim 3. To evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in Canóvanas, Puerto Rico.
Aim 4. To adapt and update intervention materials
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Cultivando La Salud
- Keywords
- Hispanic women, Behavioral Intervention, Lay Health Workers
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultivando La SaludBehavioural
A lay health worker delivered educational intervention for breast and cervical cancer screening.
In total, the Intervention Group subject participation will take approx. up to four hours (1 hour for interview, 1 hour for the second interview, and 1-2 hours for the CLS intervention) and Control Group up to four hours (One hour for interview, one hour for the second interview, up to two hours for educational intervention after the second interview).
Follow-up data was collected 4-6 months post education session (intervention group) or post-baseline survey (control group).
| Study group | Role | What they receive |
|---|---|---|
| Cultivando la Salud Educational Intervention | Experimental | After completing eligibility and baseline surveys, Lay health workers delivered an educational intervention for breast and cervical cancer screening. This educational session was delivered in participants' home and lasted between 1-2 hours. Follow-up data was collected 4-6 months post educational session. Receives: Behavioral: Cultivando La Salud |
| Control | No intervention | No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.
Measured: 4-6 months after the intervention
Number of participants aged 40 and older who completed a mammography test
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.
Measured: 4-6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 May 2012
- Primary completion20 Sep 2013
- Study completion2 Jul 2020
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 Breast 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
- Single group
- Model description
- A randomized controlled trial using a pre-post comparison group design. Eligibility criteria included ages 21 and older for the Pap cohort and 40 and older for the mammography cohort, non-adherence to recommended Pap test screening and/or mammography screening guidelines according to the American Cancer Society, no hysterectomy, no diagnosis of cancer, and not currently pregnant. Trained data collectors administered a baseline survey to eligible women and randomly assigned them to the intervention or to a comparison condition. Lay Health Workers delivered the intervention in women's homes, and administered the follow-up survey by phone 4 to 6 months following baseline.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Colon, University of Puerto Rico
- Investigators
- Vivian Colón-López, PhD, Principal investigator, Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617236
- Sponsor's protocol ID
- A1250312
- Acronym
- CLS
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colon-Lopez V, Gonzalez D, Velez C, Fernandez-Espada N, Feldman-Soler A, Ayala-Escobar K, Ayala-Marin AM, Soto-Salgado M, Calo WA, Pattatucci-Aragon A, Rivera-Diaz M, Fernandez ME. Community-Academic Partnership to Implement a Breast and Cervical Cancer Screening Education Program in Puerto Rico. P R Health Sci J. 2017 Dec;36(4):191-197.
PubMed 29220062
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
- ClinicalTrials.gov ID
- NCT04617236
- Acronym / sponsor ID
- CLS / A1250312
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Hispanic women, Behavioral Intervention, Lay Health Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 15 May 2012 (actual)
- Primary completion
- 20 Sep 2013 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 5 Nov 2020 (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.
The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in Canóvanas, Puerto Rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. To evaluate promotoras' delivery of the CLS screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the CLS intervention program compared with usual practice (no intervention).
Detailed description
The proposed promotora and community based breast and cervical screening education program includes the following specific aims:
Aim 1. To train community health workers (promotoras) from Taller Salud to implement the CLS breast and cervical cancer screening program. Taller Salud staff train and build capacity of promotoras to implement the CLS community-based education and navigation program.
Aim 2. To deliver the CLS intervention program to at least 600 women in Canóvanas municipality, Puerto Rico.
Aim 3. To evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in Canóvanas, Puerto Rico.
Aim 4. To adapt and update intervention materials
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial using a pre-post comparison group design. Eligibility criteria included ages 21 and older for the Pap cohort and 40 and older for the mammography cohort, non-adherence to recommended Pap test screening and/or mammography screening guidelines according to the American Cancer Society, no hysterectomy, no diagnosis of cancer, and not currently pregnant. Trained data collectors administered a baseline survey to eligible women and randomly assigned them to the intervention or to a comparison condition. Lay Health Workers delivered the intervention in women's homes, and administered the follow-up survey by phone 4 to 6 months following baseline.
| Arm | Type | Receives |
|---|---|---|
| Cultivando la Salud Educational Intervention | Experimental | Behavioral: Cultivando La SaludAfter completing eligibility and baseline surveys, Lay health workers delivered an educational intervention for breast and cervical cancer screening. This educational session was delivered in participants' home and lasted between 1-2 hours. Follow-up data was collected 4-6 months post educational session. |
| Control | No intervention | –No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 21 and older for Pap cohort
- Women aged 40 and older for Mammography cohort
Key exclusion criteria (5 listed)
- Having completed a Papanicolau test in the past 3 years if participant is between the ages of 21-65.
- Having completed a Mammography screening in the past year if participant is aged 40 or older
- Have a hysterectomy
- Currently pregnant
- History of any type of cancer
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 |
|---|---|---|
| Cultivando La SaludA lay health worker delivered educational intervention for breast and cervical cancer screening. In total, the Intervention Group subject participation will take approx. up to four hours (1 hour for interview, 1 hour for the second interview, and 1-2 hours for the CLS intervention) and Control Group up to four hours (One hour for interview, one hour for the second interview, up to two hours for educational intervention after the second interview). Follow-up data was collected 4-6 months post education session (intervention group) or post-baseline survey (control group). | Behavioural | Cultivando la Salud Educational Intervention |
Primary outcome
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)
Time frame: 4-6 months after the intervention
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.
Number of participants aged 40 and older who completed a mammography test
Time frame: 4-6 months after the intervention
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.
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 5 Nov 2020.
- Results publication: PubMed 29220062Colon-Lopez V, Gonzalez D, Velez C, Fernandez-Espada N, Feldman-Soler A, Ayala-Escobar K, Ayala-Marin AM, Soto-Salgado M, Calo WA, Pattatucci-Aragon A, Rivera-Diaz M, Fernandez ME. Community-Academic Partnership to Implement a Breast and Cervical Cancer Screening Education Program in Puerto Rico. P R Health Sci J. 2017 Dec;36(4):191-197.
- Individual participant dataSharing planned: No
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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.
Vivian Colón-López, PhD principal investigator
Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultivando La Salud in people with Breast Cancer and Cervical Cancer, run by University of Puerto Rico at 1 site in Puerto Rico.
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 2 inclusion and 5 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 5 Nov 2020. 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 Puerto Rico. 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?
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test) (time frame: 4-6 months after the intervention). The study lists 2 primary outcomes in all. 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 NCT04617236, 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 5 Nov 2020.