Hereditary Breast and Ovarian Cancer SyndromeNCT02956681
Statewide Communication to Reach Diverse Low Income Women
A study testing Intervention Group and Delayed Intervention Group in people with Hereditary Breast and Ovarian Cancer Syndrome, run by University of California, San Francisco.
Trial summary
Recruitment for prevention, and early detection among health disparities populations represents a major challenge in chronic disease control. This effect is magnified for individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- Intervention Group and Delayed Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jun 2013
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residence within one of six local counties (for ease of access to our sites offering free genetic counseling and testing), age 25+, and English- or Spanish-speaking (the languages in which genetic counseling was conducted at risk program sites).
Who cannot join
- American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander will not be included since very few call EWC.
- Children (individuals under 25 years of age) will not be included in the study.
- The rationale for this exclusion is that the research topic is not relevant to children.
- The EWC does not target children, whose medical care is typically under the control of their parents or guardians.
About this study
Recruitment for prevention, and early detection among health disparities populations represents a major challenge in chronic disease control. This effect is magnified for individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis. Costs are typically high, particularly given the common practice of developing a single outreach channel to address each disease or condition. In a randomized delayed intervention control trial, the investigators tested a strategy to identify low-income women at high risk for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them to free genetic counseling.
Read the detailed description
This study addresses a disparity in services related to the rare but serious condition of HBOC. In a randomized delayed intervention control trial, the investigators were able to identify high-risk but predominantly unaffected women among callers seeking referrals to free cancer screening. The investigators compared an immediate offer of a genetic counseling appointment to information on hereditary breast and ovarian cancer sent by mail. Our study demonstrated that when a diverse population of low-income women calls a trusted information and referral source, it is possible to both engage them on a topic that is different from the purpose for their call and to recruit them for participation in research.
Our intervention was designed to fit as seamlessly as possible with two end user organizations. Existing staff (Information Specialists) of the state's phone service administered a simple family history screener similar to their usual procedure for assessing eligibility for free mammography. Cancer Risk Program Genetic Counseling Assistants followed up with an outcall, just as they do normally in response to family history screeners filled out in the hospital's mammography clinic. Our results not only showed a significantly larger effect on use of genetic counseling with the call and appointment offer compared with a mailed brochure, it was clear from calls made to women in both arms after the intervention period that calling is not only effective but essential to encourage use of genetic counseling in this population. The number of women counseled in the intervention group was initially much higher than the control group, and additional intervention group members obtained counseling when called again after the two month intervention period. The addition of genetic counseling by phone enabled a substantial number of women to obtain counseling who would not have done so otherwise. Our study demonstrated that, for the complex and highly personal issue of HBOC, multiple attempts over a period of months are needed and justified.
- Being tested
- Intervention Group, Delayed Intervention Group
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that a genetic counselor will call them back to offer them a free genetic counseling appointment and that a brochure will be sent. A UCSF/SFGH genetic counseling assistant will call them back within a few days to offer them a free genetic counseling appointment at SFGH.
Delayed Intervention GroupBehavioural
This is a randomized delayed intervention control trial in which eligible callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that they are eligible to speak to a genetic counselor who is available at no charge at SFGH and that they will be sent a brochure with information on where to call.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention Group | Active comparator | In this arm of the randomized delayed intervention control trial, participants randomized to delayed intervention control group were sent a brochure with information on hereditary breast and ovarian cancer and the phone number to call a cancer risk program for free genetic counseling. Receives: Behavioral: Delayed Intervention Group |
| Intervention Group | Active comparator | In this arm of the randomized delayed intervention control trial, those randomized to the intervention group were told that because of their family history, we were able to offer them a free genetic counseling appointment. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Genetic Counseling During Intervention Period
The primary outcome measure is receipt of genetic counseling within the two month intervention period.
Measured: Up to three years
Secondary outcomes (1)
Time to Counseling
The study arms were compared with respect to time from randomization to counseling appointment using the log-rank test, and Kaplan-Meier curves were computed for each study arm.
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startOct 2007
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Institute of California
- Responsible party
- Sponsor
- Investigators
- Rena J Pasick, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956681
- Sponsor's protocol ID
- UCSF-SW-2007
- Other IDs
- R01CA129096
- Status last verified
- Sep 2021
- First submitted
- 17 May 2016
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statewide Communication to Reach Diverse Low Income Women
- ClinicalTrials.gov ID
- NCT02956681
- Acronym / sponsor ID
- UCSF-SW-2007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Institute of California
- Study start
- Oct 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Nov 2016 (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.
Recruitment for prevention, and early detection among health disparities populations represents a major challenge in chronic disease control. This effect is magnified for individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis. Costs are typically high, particularly given the common practice of developing a single outreach channel to address each disease or condition. In a randomized delayed intervention control trial, the investigators tested a strategy to identify low-income women at high risk for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them to free genetic counseling.
Detailed description
This study addresses a disparity in services related to the rare but serious condition of HBOC. In a randomized delayed intervention control trial, the investigators were able to identify high-risk but predominantly unaffected women among callers seeking referrals to free cancer screening. The investigators compared an immediate offer of a genetic counseling appointment to information on hereditary breast and ovarian cancer sent by mail. Our study demonstrated that when a diverse population of low-income women calls a trusted information and referral source, it is possible to both engage them on a topic that is different from the purpose for their call and to recruit them for participation in research.
Our intervention was designed to fit as seamlessly as possible with two end user organizations. Existing staff (Information Specialists) of the state's phone service administered a simple family history screener similar to their usual procedure for assessing eligibility for free mammography. Cancer Risk Program Genetic Counseling Assistants followed up with an outcall, just as they do normally in response to family history screeners filled out in the hospital's mammography clinic. Our results not only showed a significantly larger effect on use of genetic counseling with the call and appointment offer compared with a mailed brochure, it was clear from calls made to women in both arms after the intervention period that calling is not only effective but essential to encourage use of genetic counseling in this population. The number of women counseled in the intervention group was initially much higher than the control group, and additional intervention group members obtained counseling when called again after the two month intervention period. The addition of genetic counseling by phone enabled a substantial number of women to obtain counseling who would not have done so otherwise. Our study demonstrated that, for the complex and highly personal issue of HBOC, multiple attempts over a period of months are needed and justified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention Group | Active comparator | Behavioral: Delayed Intervention GroupIn this arm of the randomized delayed intervention control trial, participants randomized to delayed intervention control group were sent a brochure with information on hereditary breast and ovarian cancer and the phone number to call a cancer risk program for free genetic counseling. |
| Intervention Group | Active comparator | Behavioral: Intervention GroupIn this arm of the randomized delayed intervention control trial, those randomized to the intervention group were told that because of their family history, we were able to offer them a free genetic counseling appointment. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residence within one of six local counties (for ease of access to our sites offering free genetic counseling and testing), age 25+, and English- or Spanish-speaking (the languages in which genetic counseling was conducted at risk program sites).
Key exclusion criteria (4 listed)
- American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander will not be included since very few call EWC.
- Children (individuals under 25 years of age) will not be included in the study.
- The rationale for this exclusion is that the research topic is not relevant to children.
- The EWC does not target children, whose medical care is typically under the control of their parents or guardians.
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 |
|---|---|---|
| Intervention GroupCallers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that a genetic counselor will call them back to offer them a free genetic counseling appointment and that a brochure will be sent. A UCSF/SFGH genetic counseling assistant will call them back within a few days to offer them a free genetic counseling appointment at SFGH. | Behavioural | Intervention Group |
| Delayed Intervention GroupThis is a randomized delayed intervention control trial in which eligible callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that they are eligible to speak to a genetic counselor who is available at no charge at SFGH and that they will be sent a brochure with information on where to call. | Behavioural | Delayed Intervention Group |
Primary outcome
Receipt of Genetic Counseling During Intervention Period
Time frame: Up to three years
The primary outcome measure is receipt of genetic counseling within the two month intervention period.
1 secondary outcome
Time to Counseling
Time frame: Up to three years
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 4 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Hereditary Breast and Ovarian Cancer Syndrome
Not yet recruiting
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants
Ovarian Neoplasms, BRCA 1 Gene Mutation
Recruiting
EHR Intervention to Increase HBOC Genetic Testing
Breast Cancer, Ovarian Cancer
RecruitingObservational study
CfDNA in Hereditary And High-risk Malignancies 2
Hereditary Cancer Syndrome
Active, not recruiting
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma
RecruitingObservational study
Liquid Biopsy Evaluation and Repository Development at Princess Margaret
Cancer, Breast Cancer
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.
Rena J Pasick, DrPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group and Delayed Intervention Group in people with Hereditary Breast and Ovarian Cancer Syndrome, run by University of California, San Francisco.
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 1 inclusion and 4 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Receipt of Genetic Counseling During Intervention Period (time frame: Up to three years). 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 4 Oct 2021.