Breast CancerREACHNCT01346761
Risk Education and Assessment for Cancer Heredity
A study testing Telephone Genetic Counseling and In-Person Genetic Counseling in people with Breast Cancer and Ovarian Cancer, run by University of Utah at 1 site in United States.
Trial summary
Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this… Read more about this study
- Who is it for?
- Ages 25 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Genetic Predisposition
- What is being tested?
- Telephone Genetic Counseling and In-Person Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2012
- 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 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Utah resident
- Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation).
Who cannot join
- Has had genetic counseling and/or BRCA 1/2 testing
- Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent.
- Unable to read and speak English fluently
- Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah)
- Male gender
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84118
About this study
Official title: Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women
Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.
Read the detailed description
Following confirmation of eligibility and completion of baseline surveys, participants will be randomly assigned to one of the study arms by the project coordinator, using a computer-generated allocation algorithm on the basis of a randomization blocks method using four, six or eight participants in each block.
In-person and telephone counseling will be delivered by the same board-certified genetic counselors using a guideline-concordant semi-structured protocol that will allow for personalization of counseling.
Participants randomly assigned to telephone counseling will be mailed packets that include a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer genetic counseling with visual aids. At the time of their session, participants will review the brochure and genetic counselors will use visual aids to explain breast-ovarian cancer genetics. Women receiving in-person counseling will be given the same materials during their session at the community clinic.
For women who elect to have testing, those who have telephone counseling will be sent a genetic test kit; those who have in-person counseling will have the option of giving a sample immediately at the clinic, or will be given a test kit with the same instructions as those in the telephone-counseling group.
When BRCA test results become available, participants will be offered individual post-test counseling with the same genetic counselor who conducted the pretest session.
- Conditions
- Breast Cancer, Ovarian Cancer, Genetic Predisposition
- Being tested
- Telephone Genetic Counseling, In-Person Genetic Counseling
- Keywords
- Genetic Counseling, Genetic Counseling Interventions, Genetic Testing, BRCA1 gene, BRCA2 gene, Risk Communication
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Genetic Predisposition to Disease, Fanconi Anemia, Complementation Group D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Genetic CounselingBehavioural
Also called BRCA1/BRCA2 genetic counseling via telephone
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention.
In-Person Genetic CounselingBehavioural
Also called BRCA1/BRCA2 traditional genetic counseling in-person
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Telephone genetic counseling | Experimental | Participants randomly assigned to telephone counseling are mailed packets that included a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer (HBOC) genetic counseling with visual aids. At the time of their session, participants open their envelope and counselors use the visual aids to explain breast-ovarian cancer genetics and administer BRCA1/BRCA2 genetic counseling. Women receiving in-person counseling are given these same materials during their session at the community clinic. In-person and telephone counseling are delivered by the same five board-certified genetic counselors. Receives: Behavioral: Telephone Genetic Counseling |
| In-person genetic counseling | Active comparator | In-person BRCA1/BRCA2 genetic counseling is delivered by board-certified genetic counselors using a guide-line-concordant semistructured protocol that allows for personalization of counseling and is similar to that used by others. All sessions are audiotaped for treatment fidelity assessments. In-person and telephone counseling are delivered by the same five board-certified genetic counselors. Receives: Behavioral: In-Person Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
- Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling.
- Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes.
- Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.
Measured: 6 &12-month follow-up
Secondary outcomes (1)
Determine the feasibility of the intervention
- Examine the intervention delivery and patient costs of telephone genetic counseling relative to in-person genetic counseling.
- Examine mediators (sociodemographic, communication factors, health care access, clinical, \& psychosocial factors) of genetic testing decisions, and affective and cognitive outcomes.
- Compare decisions and perceptions about use of primary/secondary prevention strategies for hereditary breast/ovarian cancer.
Measured: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startAug 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anita Kinney, University of Utah
- Investigators
- Anita Y. Kinney, R.N., Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346761
- Sponsor's protocol ID
- 23146
- Other IDs
- 1R01CA129142-01A2
- Acronym
- REACH
- Status last verified
- Apr 2016
- First submitted
- 29 Apr 2011
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steffen LE, Du R, Gammon A, Mandelblatt JS, Kohlmann WK, Lee JH, Buys SS, Stroup AM, Campo RA, Flores KG, Vicuna B, Schwartz MD, Kinney AY. Genetic Testing in a Population-Based Sample of Breast and Ovarian Cancer Survivors from the REACH Randomized Trial: Cost Barriers and Moderators of Counseling Mode. Cancer Epidemiol Biomarkers Prev. 2017 Dec;26(12):1772-1780. doi: 10.1158/1055-9965.EPI-17-0389. Epub 2017 Sep 29.
PubMed 28971986Kinney AY, Steffen LE, Brumbach BH, Kohlmann W, Du R, Lee JH, Gammon A, Butler K, Buys SS, Stroup AM, Campo RA, Flores KG, Mandelblatt JS, Schwartz MD. Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up. J Clin Oncol. 2016 Aug 20;34(24):2914-24. doi: 10.1200/JCO.2015.65.9557. Epub 2016 Jun 20.
PubMed 27325848
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women
- ClinicalTrials.gov ID
- NCT01346761
- Acronym / sponsor ID
- REACH / 23146
- Conditions
- Breast Cancer, Ovarian Cancer, Genetic Predisposition
- Keywords
- Genetic Counseling, Genetic Counseling Interventions, Genetic Testing, BRCA1 gene, BRCA2 gene, Risk Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 May 2011 (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.
Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.
Detailed description
Following confirmation of eligibility and completion of baseline surveys, participants will be randomly assigned to one of the study arms by the project coordinator, using a computer-generated allocation algorithm on the basis of a randomization blocks method using four, six or eight participants in each block.
In-person and telephone counseling will be delivered by the same board-certified genetic counselors using a guideline-concordant semi-structured protocol that will allow for personalization of counseling.
Participants randomly assigned to telephone counseling will be mailed packets that include a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer genetic counseling with visual aids. At the time of their session, participants will review the brochure and genetic counselors will use visual aids to explain breast-ovarian cancer genetics. Women receiving in-person counseling will be given the same materials during their session at the community clinic.
For women who elect to have testing, those who have telephone counseling will be sent a genetic test kit; those who have in-person counseling will have the option of giving a sample immediately at the clinic, or will be given a test kit with the same instructions as those in the telephone-counseling group.
When BRCA test results become available, participants will be offered individual post-test counseling with the same genetic counselor who conducted the pretest session.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone genetic counseling | Experimental | Behavioral: Telephone Genetic CounselingParticipants randomly assigned to telephone counseling are mailed packets that included a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer (HBOC) genetic counseling with visual aids. At the time of their session, participants open their envelope and counselors use the visual aids to explain breast-ovarian cancer genetics and administer BRCA1/BRCA2 genetic counseling. Women receiving in-person counseling are given these same materials during their session at the community clinic. In-person and telephone counseling are delivered by the same five board-certified genetic counselors. |
| In-person genetic counseling | Active comparator | Behavioral: In-Person Genetic CounselingIn-person BRCA1/BRCA2 genetic counseling is delivered by board-certified genetic counselors using a guide-line-concordant semistructured protocol that allows for personalization of counseling and is similar to that used by others. All sessions are audiotaped for treatment fidelity assessments. In-person and telephone counseling are delivered by the same five board-certified genetic counselors. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Utah resident
- Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation).
Key exclusion criteria (5 listed)
- Has had genetic counseling and/or BRCA 1/2 testing
- Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent.
- Unable to read and speak English fluently
- Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah)
- Male gender
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 |
|---|---|---|
| Telephone Genetic CounselingAlso: BRCA1/BRCA2 genetic counseling via telephoneParticipants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention. | Behavioural | Telephone genetic counseling |
| In-Person Genetic CounselingAlso: BRCA1/BRCA2 traditional genetic counseling in-personParticipants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention. | Behavioural | In-person genetic counseling |
Primary outcome
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
Time frame: 6 &12-month follow-up
1. Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling. 2. Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes. 3. Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.
1 secondary outcome
Determine the feasibility of the intervention
Time frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups
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 14 Apr 2016.
- Derived from this study: PubMed 28971986Steffen LE, Du R, Gammon A, Mandelblatt JS, Kohlmann WK, Lee JH, Buys SS, Stroup AM, Campo RA, Flores KG, Vicuna B, Schwartz MD, Kinney AY. Genetic Testing in a Population-Based Sample of Breast and Ovarian Cancer Survivors from the REACH Randomized Trial: Cost Barriers and Moderators of Counseling Mode. Cancer Epidemiol Biomarkers Prev. 2017 Dec;26(12):1772-1780. doi: 10.1158/1055-9965.EPI-17-0389. Epub 2017 Sep 29.
- Derived from this study: PubMed 27325848Kinney AY, Steffen LE, Brumbach BH, Kohlmann W, Du R, Lee JH, Gammon A, Butler K, Buys SS, Stroup AM, Campo RA, Flores KG, Mandelblatt JS, Schwartz MD. Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up. J Clin Oncol. 2016 Aug 20;34(24):2914-24. doi: 10.1200/JCO.2015.65.9557. Epub 2016 Jun 20.
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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.
Anita Y. Kinney, R.N., Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Genetic Counseling and In-Person Genetic Counseling in people with Breast Cancer and Ovarian Cancer, run by University of Utah 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 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 14 Apr 2016. 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?
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling (time frame: 6 &12-month follow-up). 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 NCT01346761, which also lists 2 linked publications.
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 14 Apr 2016.