Breast CancerPhase 1NCT01605630
Family Cancer Literacy to Promote Mammography Screening Among Navajo Women
A Phase 1 study testing Family-based family cancer literacy intervention in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Family-based family cancer literacy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2017
- Phase
- Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In Phase 1, we will recruit 17 Navajo women for individual interviews (n=5) and focus groups (n=12) to adapt our measures. Eligibility criteria are:
- aged 40 years or older and
- provides written informed consent. We chose to develop our measures based on feedback from the general community of women who are screening eligible instead of matching the inclusion/exclusion criteria to that used in the formative evaluation of the intervention (Phase 2). This will enhance our ability to use the Cancer Literacy Measure and other assessments in subsequent breast cancer prevention and control studies.
- In Phase 2, we will recruit a total of 40 patient-family member pairs. To be eligible for the study, the NNBCCPP patient must:
- be aged 40 years or older,
- provide written informed consent,
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- be referred to the NNBCCPP as a "no-show" for mammography screening after three scheduling attempts,
- have no prior history of mammography screening,
- have no prior history of breast cancer, and
- can identify a female family member or other individual who resides in or near the home who could participate in the project.
- In addition, the family member must:
- be female,
- aged 18 years or older,
- be fluent and literate in Navajo,
- be interested and able to participate, and
- provide written informed consent.
Who cannot join
- Phase 2: History of breast cancer or mammography screening
Trial locations and contacts
1 site in 1 country.
About this study
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
Read the detailed description
This proposal describes a community-based participatory research study to develop and pilot test a new behavioral intervention to promote mammography screening among Navajo women. From a public health perspective, the intervention has the potential to reach many Navajo women, as 80% of women scheduled for mammography appointments do not follow through. These women (over 1,500 each year) are referred to the Nation Breast and Cervical Cancer Prevention Program (NNBCCPP). A key barrier toward implementing cancer prevention and control efforts in the Navajo community is a lack of cancer literacy or cultural and conceptual knowledge regarding cancer. Other barriers to screening are fear of cancer, stigma of cancer (even talking about cancer) often experienced by the patient, family and community, and lack of knowledge about the etiology of cancer and importance of early detection. Therefore, communication about cancer is impeded within Navajo families and the community.
This proposal builds on our successful partnership and collaboration with Diné College (the Navajo tribal college). The proposed study is designed to assess the feasibility and potential efficacy of a cancer-literacy focused, family-based intervention on completion of mammography screening for Navajo women. The intervention will include culturally and linguistically appropriate educational materials about cancer (e.g., the Navajo Cancer Glossary). The project will be implemented in two phases. During Phase 1, the investigators will develop the family cancer literacy intervention with feedback from our community advisory committee. In addition, the Cancer Literacy Measure will be adapted for Navajo women through focus groups and individual interviews. Phase 2 will consist of a formative evaluation of the intervention. The NNBCCPP patient and a female family member will be randomly assigned in pairs to the control condition (existing NNBCCPP health education services, N=40 pairs) or to receive these health education services plus the family cancer literacy intervention (N=40 pairs). The investigators will assess the intervention's feasibility and acceptability as indicated by the recruitment and retention rates and qualitative ratings of treatment acceptability. In addition, the investigators will examine the effect of the intervention compared with the control group on the proportion of women who complete mammography screening at 3-month follow-up documented by NNBCCPP records. The investigators will also examine changes in Cancer Literacy Measure scores from baseline to 3-month follow-up among both patients and family members. The investigators expect that as a result of this project, the investigators will have developed a replicable, feasible, and acceptable intervention, the efficacy of which can be tested in future large-scale randomized clinical trials. In addition, the adapted Cancer Literacy Measure could be used in future cancer prevention and control projects within the Navajo Nation. The overall objective is to reduce breast cancer morbidity and mortality among Navajo women.
- Conditions
- Breast Cancer
- Being tested
- Family-based family cancer literacy intervention, Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based family cancer literacy interventionBehavioural
family based counseling and materials provided in navajo/english including digital stories
ControlBehavioural
standard of care
| Study group | Role | What they receive |
|---|---|---|
| Family-based cancer literacy intervention | Experimental | Not described Receives: Behavioral: Family-based family cancer literacy intervention |
| Control | Active comparator | Standard of care Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
Participants will be asked if they found the intervention to be helpful or not and if they would recommend it to other women
Measured: Participants will be assesed at 3 month follow-up
Secondary outcomes (2)
Changes in Cancer Literacy Measure
Participants will be asked about breast cancer screening knowledge and attitudes including cultural barriers to screening
Measured: participants will be assessed at baseline and at 3 month follow-up
completion of mammography screening
Based on program records we will determine if participants completed mammography screening or not
Measured: participants will be assessed from the time of enrollment to 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi A Patte, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605630
- Sponsor's protocol ID
- 11-004328
- Other IDs
- R21CA152433
- Status last verified
- Dec 2017
- First submitted
- 7 May 2012
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Cancer Literacy to Promote Mammography Screening Among Navajo Women
- ClinicalTrials.gov ID
- NCT01605630
- Acronym / sponsor ID
- 11-004328
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 May 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.
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
Detailed description
This proposal describes a community-based participatory research study to develop and pilot test a new behavioral intervention to promote mammography screening among Navajo women. From a public health perspective, the intervention has the potential to reach many Navajo women, as 80% of women scheduled for mammography appointments do not follow through. These women (over 1,500 each year) are referred to the Nation Breast and Cervical Cancer Prevention Program (NNBCCPP). A key barrier toward implementing cancer prevention and control efforts in the Navajo community is a lack of cancer literacy or cultural and conceptual knowledge regarding cancer. Other barriers to screening are fear of cancer, stigma of cancer (even talking about cancer) often experienced by the patient, family and community, and lack of knowledge about the etiology of cancer and importance of early detection. Therefore, communication about cancer is impeded within Navajo families and the community.
This proposal builds on our successful partnership and collaboration with Diné College (the Navajo tribal college). The proposed study is designed to assess the feasibility and potential efficacy of a cancer-literacy focused, family-based intervention on completion of mammography screening for Navajo women. The intervention will include culturally and linguistically appropriate educational materials about cancer (e.g., the Navajo Cancer Glossary). The project will be implemented in two phases. During Phase 1, the investigators will develop the family cancer literacy intervention with feedback from our community advisory committee. In addition, the Cancer Literacy Measure will be adapted for Navajo women through focus groups and individual interviews. Phase 2 will consist of a formative evaluation of the intervention. The NNBCCPP patient and a female family member will be randomly assigned in pairs to the control condition (existing NNBCCPP health education services, N=40 pairs) or to receive these health education services plus the family cancer literacy intervention (N=40 pairs). The investigators will assess the intervention's feasibility and acceptability as indicated by the recruitment and retention rates and qualitative ratings of treatment acceptability. In addition, the investigators will examine the effect of the intervention compared with the control group on the proportion of women who complete mammography screening at 3-month follow-up documented by NNBCCPP records. The investigators will also examine changes in Cancer Literacy Measure scores from baseline to 3-month follow-up among both patients and family members. The investigators expect that as a result of this project, the investigators will have developed a replicable, feasible, and acceptable intervention, the efficacy of which can be tested in future large-scale randomized clinical trials. In addition, the adapted Cancer Literacy Measure could be used in future cancer prevention and control projects within the Navajo Nation. The overall objective is to reduce breast cancer morbidity and mortality among Navajo women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based cancer literacy intervention | Experimental | Behavioral: Family-based family cancer literacy intervention |
| Control | Active comparator | Behavioral: ControlStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- In Phase 1, we will recruit 17 Navajo women for individual interviews (n=5) and focus groups (n=12) to adapt our measures. Eligibility criteria are:
- aged 40 years or older and
- provides written informed consent. We chose to develop our measures based on feedback from the general community of women who are screening eligible instead of matching the inclusion/exclusion criteria to that used in the formative evaluation of the intervention (Phase 2). This will enhance our ability to use the Cancer Literacy Measure and other assessments in subsequent breast cancer prevention and control studies.
- In Phase 2, we will recruit a total of 40 patient-family member pairs. To be eligible for the study, the NNBCCPP patient must:
- be aged 40 years or older,
Key exclusion criteria (1 listed)
- Phase 2: History of breast cancer or mammography screening
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 |
|---|---|---|
| Family-based family cancer literacy interventionfamily based counseling and materials provided in navajo/english including digital stories | Behavioural | Family-based cancer literacy intervention |
| Controlstandard of care | Behavioural | Control |
Primary outcome
Acceptability of the intervention
Time frame: Participants will be assesed at 3 month follow-up
Participants will be asked if they found the intervention to be helpful or not and if they would recommend it to other women
2 secondary outcomes
Changes in Cancer Literacy Measure
Time frame: participants will be assessed at baseline and at 3 month follow-up
completion of mammography screening
Time frame: participants will be assessed from the time of enrollment to 3 month follow-up
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 19 Dec 2017.
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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.
Christi A Patte, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Family-based family cancer literacy intervention in people with Breast Cancer, run by Mayo Clinic 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 16 inclusion and 1 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 19 Dec 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acceptability of the intervention (time frame: Participants will be assesed at 3 month follow-up). 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 19 Dec 2017.