Breast CarcinomaNCT04208724
Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization
A study testing Training, Cancer Screening intervention and Survey Administration in people with Breast Carcinoma and Cervical Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This pilot trial study uses a structural support program for adoption of cancer screening interventions at a rural community-based organization. Rural communities face unique barriers in implementation of evidence-based interventions due to a lack of infrastructure, community capacity, and expertise as academic and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma
- What is being tested?
- Training, Cancer Screening intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 30 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Objective II COMMUNITY-BASED ORGANIZATION: Located in the Yakima Valley of Washington State
- Objective II COMMUNITY-BASED ORGANIZATION: Serve community members who are 18 and older
- Objective II COMMUNITY-BASED ORGANIZATION: Willing to commit to the 6-month program
- Objective II PARTICIPANTS: Receiving services from the recruited community-based organization
- Objective III PARTICIPANTS: Not up-to-date for breast, cervical, and colorectal cancer screening according to current U.S. Preventive Services Tasks Force (USPSTF) guidelines. The current USPSTF recommendations for breast, cervical, and colorectal cancer are:
- Breast Cancer Screening: Women ages 50-74 should be screened for breast cancer with mammography every 2 years.
Show all 12Show fewer
- Cervical Cancer Screening: Women ages 21-29 should be screened for cervical cancer every 3 years with cervical cancer cytology alone. For women ages 30-65, the USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years or every 5 years with high risk human papillomavirus (hrHPV) testing in combination of cytology.
- Colorectal Cancer Screening: Individuals ages 50-75 should be screened for colorectal cancer with guaiac-based fecal occult blood tests (gFOBT) or fecal immunochemical test (FIT) once a year, or colonoscopy every 10 years (USPSTF approves additional screening tests, but these are the most commonly used).
- Objective III PARTICIPANTS: If the community-based organization selects breast cancer screening, we will recruit women ages 50-74.
- Objective III PARTICIPANTS: If the community-based organization selects cervical cancer screening, we will recruit women ages 21-65.
- Objective III PARTICIPANTS: If the community-based organization selects colorectal cancer screening, we will recruit women and men ages 50-75.
- Objective III PARTICIPANTS: Average risk for breast, cervical, or colorectal cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Implementation Studio, an Innovative, Structured Approach to Facilitate Rural Community-Based Organizations' Adaptation and Implementation of Evidence-Based Interventions
This pilot trial study uses a structural support program for adoption of cancer screening interventions at a rural community-based organization. Rural communities face unique barriers in implementation of evidence-based interventions due to a lack of infrastructure, community capacity, and expertise as academic and research centers are often clustered in urban areas. The support program may help a rural community-based organization select, adapt, and implement cancer prevention and control evidence-based interventions.
Read the detailed description
OUTLINE:
Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members.
After completion of study, participants are followed up at 3 months.
- Being tested
- Training, Cancer Screening intervention, Survey Administration
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called Training Programs
Participate in the training program
Cancer Screening interventionOther
Also called cancer screening
Receive cancer screening intervention
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Training program | Experimental | Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members. Receives: Other: Training; Other: Cancer Screening intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop the structural program
Development of the structural training program and accompanying tools
Measured: 3 months
Implementation Monitoring
Implementation of the evidence-based intervention by the community-based organization including 1) dosage (how many interventions were delivered to the participants), 2) types (for which cancer), 3) length of exposure (for how long), and 4) who is involved in the implementation (by whom).
Measured: 4 months
Intention to get screened for cancer (type of cancer will be determined by the community-based organization) pre- and post-intervention
Difference in the proportion of intention to get screened for cancer pre- and post-intervention using chi-square analyses
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start18 Nov 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 CarcinomaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Ko, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208724
- Sponsor's protocol ID
- RG1006143
- Other IDs
- NCI-2019-08033, 10307
- Status last verified
- Jul 2022
- First submitted
- 10 Dec 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko LK, Vu T, Bishop S, Leeman J, Escoffery C, Winer RL, Duran MC, Masud M, Rait Y. Implementation studio: implementation support program to build the capacity of rural community health educators serving immigrant communities to implement evidence-based cancer prevention and control interventions. Cancer Causes Control. 2023 Dec;34(Suppl 1):75-88. doi: 10.1007/s10552-023-01743-6. Epub 2023 Jul 13.
PubMed 37442868
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Studio, an Innovative, Structured Approach to Facilitate Rural Community-Based Organizations' Adaptation and Implementation of Evidence-Based Interventions
- ClinicalTrials.gov ID
- NCT04208724
- Acronym / sponsor ID
- RG1006143
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Dec 2019 (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 pilot trial study uses a structural support program for adoption of cancer screening interventions at a rural community-based organization. Rural communities face unique barriers in implementation of evidence-based interventions due to a lack of infrastructure, community capacity, and expertise as academic and research centers are often clustered in urban areas. The support program may help a rural community-based organization select, adapt, and implement cancer prevention and control evidence-based interventions.
Detailed description
OUTLINE:
Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members.
After completion of study, participants are followed up at 3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training program | Experimental | Other: Training, Other: Cancer Screening intervention, Other: Survey AdministrationCommunity-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Objective II COMMUNITY-BASED ORGANIZATION: Located in the Yakima Valley of Washington State
- Objective II COMMUNITY-BASED ORGANIZATION: Serve community members who are 18 and older
- Objective II COMMUNITY-BASED ORGANIZATION: Willing to commit to the 6-month program
- Objective II PARTICIPANTS: Receiving services from the recruited community-based organization
- Objective III PARTICIPANTS: Not up-to-date for breast, cervical, and colorectal cancer screening according to current U.S. Preventive Services Tasks Force (USPSTF) guidelines. The current USPSTF recommendations for breast, cervical, and colorectal cancer are:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TrainingAlso: Training ProgramsParticipate in the training program | Other | Training program |
| Cancer Screening interventionAlso: cancer screeningReceive cancer screening intervention | Other | Training program |
| Survey AdministrationAncillary studies | Other | Training program |
Primary outcome
Develop the structural program
Time frame: 3 months
Development of the structural training program and accompanying tools
Implementation Monitoring
Time frame: 4 months
Implementation of the evidence-based intervention by the community-based organization including 1) dosage (how many interventions were delivered to the participants), 2) types (for which cancer), 3) length of exposure (for how long), and 4) who is involved in the implementation (by whom).
Intention to get screened for cancer (type of cancer will be determined by the community-based organization) pre- and post-intervention
Time frame: Up to 3 months
Difference in the proportion of intention to get screened for cancer pre- and post-intervention using chi-square analyses
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 26 Jul 2022.
- Derived from this study: PubMed 37442868Ko LK, Vu T, Bishop S, Leeman J, Escoffery C, Winer RL, Duran MC, Masud M, Rait Y. Implementation studio: implementation support program to build the capacity of rural community health educators serving immigrant communities to implement evidence-based cancer prevention and control interventions. Cancer Causes Control. 2023 Dec;34(Suppl 1):75-88. doi: 10.1007/s10552-023-01743-6. Epub 2023 Jul 13.
- 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.
Linda Ko principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, Cancer Screening intervention and Survey Administration in people with Breast Carcinoma and Cervical Carcinoma, 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 12 inclusion and 0 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 26 Jul 2022. 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?
Develop the structural program (time frame: 3 months). The study lists 3 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 NCT04208724, 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 26 Jul 2022.