No Evidence of DiseaseNCT01230346
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
A study testing questionnaire administration, survey administration and counseling intervention in people with No Evidence of Disease and BRCA1 Syndrome, run by City of Hope Medical Center at 3 sites in United States.
Trial summary
This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk. 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
- No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome
- What is being tested?
- questionnaire administration, survey administration and counseling intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Dec 2010to 22 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
- Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
- Willing to sign consent
- Pregnant women and women of child-bearing potential are eligible for participation in this study
- Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
- Women who are under- or uninsured and come from low-income communities
- Ability to understand English or Spanish
Who cannot join
- Previous participation in GCRA
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope Medical Center
Duarte, California, 91010
University of Southern California-Keck School of Medicine
Los Angeles, California, 90033
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.
Read the detailed description
PRIMARY OBJECTIVES:
- To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.
II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.
III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.
SECONDARY OBJECTIVES:
- To explore patients' perceived barriers to GCRA through no-show telephone interviews.
OUTLINE:
Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive a culturally-informed adapted motivational interviewing telephone call.
ARM II: Patients participate in a controlled condition comprising a health habits intervention group.
ARM III: Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. All patients are mailed standard new patient packets containing questionnaires on demographics and personal health history, and a family history form. All patients then undergo genetic cancer risk assessment.
- Conditions
- No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome, Hereditary Female Breast Carcinoma, Hereditary Ovarian Carcinoma
- Being tested
- questionnaire administration, survey administration, counseling intervention, educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
survey administrationOther
Ancillary studies
counseling interventionOther
Also called counseling and communications studies
Telephone intervention
educational interventionOther
Also called intervention, educational
Telephone intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive a culturally-informed adapted motivational interviewing telephone call. Receives: Other: questionnaire administration; Other: survey administration; Other: counseling intervention; Other: educational intervention |
| Arm II | Experimental | Patients participate in a controlled condition comprising a health habits intervention group. Receives: Other: questionnaire administration; Other: survey administration; Other: counseling intervention |
| Arm III | Active comparator | Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. Receives: Other: questionnaire administration; Other: survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge
Tested using 3 x 3 repeated measures analysis of covariance (ANCOVA)s in which the within subjects variables are anxiety or perceived control, the between groups variable is group membership, and covariates include fatalism and other appropriate moderators.
Measured: One week after genetic cancer risk assessment (GCRA)
Experiences with the pre-GCRA intervention through post-intervention telephone interviews
Measured: One week after genetic cancer risk assessment (GCRA)
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
Will use a multivariate ANCOVA (MANCOVA) to test for group differences among all five preparedness scores, with step-down F ratios of each individual score, using fatalism and other moderators as covariates, as appropriate.
Measured: One week after genetic cancer risk assessment (GCRA)
Secondary outcomes (1)
Perceived barriers to GCRA through no-show telephone interviews
Measured: One week after genetic cancer risk assessment (GCRA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study start2 Dec 2010
- Primary completion10 Nov 2016
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bita Nehoray, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230346
- Sponsor's protocol ID
- 08237
- Other IDs
- NCI-2010-01998
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2010
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
- ClinicalTrials.gov ID
- NCT01230346
- Acronym / sponsor ID
- 08237
- Conditions
- No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome, Hereditary Female Breast Carcinoma, Hereditary Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 493 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Dec 2010 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 29 Oct 2010 (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.
This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.
Detailed description
PRIMARY OBJECTIVES:
- To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.
II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.
III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.
SECONDARY OBJECTIVES:
- To explore patients' perceived barriers to GCRA through no-show telephone interviews.
OUTLINE:
Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive a culturally-informed adapted motivational interviewing telephone call.
ARM II: Patients participate in a controlled condition comprising a health habits intervention group.
ARM III: Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. All patients are mailed standard new patient packets containing questionnaires on demographics and personal health history, and a family history form. All patients then undergo genetic cancer risk assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: questionnaire administration, Other: survey administration, Other: counseling intervention, Other: educational interventionPatients receive a culturally-informed adapted motivational interviewing telephone call. |
| Arm II | Experimental | Other: questionnaire administration, Other: survey administration, Other: counseling interventionPatients participate in a controlled condition comprising a health habits intervention group. |
| Arm III | Active comparator | Other: questionnaire administration, Other: survey administrationPatients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
- Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
- Willing to sign consent
- Pregnant women and women of child-bearing potential are eligible for participation in this study
- Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
Key exclusion criteria (1 listed)
- Previous participation in GCRA
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 |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Arm I, Arm II, Arm III |
| survey administrationAncillary studies | Other | Arm I, Arm II, Arm III |
| counseling interventionAlso: counseling and communications studiesTelephone intervention | Other | Arm I, Arm II |
| educational interventionAlso: intervention, educationalTelephone intervention | Other | Arm I |
Primary outcome
Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge
Time frame: One week after genetic cancer risk assessment (GCRA)
Tested using 3 x 3 repeated measures analysis of covariance (ANCOVA)s in which the within subjects variables are anxiety or perceived control, the between groups variable is group membership, and covariates include fatalism and other appropriate moderators.
Experiences with the pre-GCRA intervention through post-intervention telephone interviews
Time frame: One week after genetic cancer risk assessment (GCRA)
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
Time frame: One week after genetic cancer risk assessment (GCRA)
Will use a multivariate ANCOVA (MANCOVA) to test for group differences among all five preparedness scores, with step-down F ratios of each individual score, using fatalism and other moderators as covariates, as appropriate.
1 secondary outcome
Perceived barriers to GCRA through no-show telephone interviews
Time frame: One week after genetic cancer risk assessment (GCRA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for No Evidence of Disease
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
RecruitingObservational study
Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors
Survivorship, Recurrent
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
RecruitingPhase 2
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Colorectal Neoplasms Malignant
RecruitingPhase 2
A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
Colorectal 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.
Bita Nehoray principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, survey administration and counseling intervention in people with No Evidence of Disease and BRCA1 Syndrome, run by City of Hope Medical Center at 3 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge (time frame: One week after genetic cancer risk assessment (GCRA)). 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?
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 Oct 2026.