Breast CancerNCT02644382
Improving Surgical Decision-making in Young Women With Breast Cancer
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute.
Trial summary
The overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective 1. Conduct short in-person interviews with young women prior to surgery 2. Conduct focus groups with breast cancer survivors about their surgical decision and experience 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- qualitative data collection, survey and decision aid
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2016to 10 Apr 2020
- Phase
- Observational
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young Women with a history of breast cancer and providers who care for them.
Who may be able to join
- Patients for key informant interviews-
- Newly diagnosed women with Stage 0-3 breast cancer
- Between the ages of 18 and 40 who are seen at DFCI and have not yet had their primary breast cancer surgery.
- Patients for focus groups:
- diagnosis of Stage 0-3 breast cancer at age 40 and younger
- currently between the ages of 18-43
Show all 18Show fewer
- English-speaking
- 1-3 years from diagnosis
- Had breast cancer surgery
- no evidence of recurrent or metastatic disease.
- Providers:
- Must care for women who have breast cancer. Can be surgeons, surgical oncologists, medical and/or radiation oncologists
- Patients for Surgical Decision Making Pilot
- Women with newly-diagnosed, unilateral Stage 0-3 breast cancer
- Between the ages of 18 and 40
- Who are seen by a surgeon at DFCI/BWH or Faulkner Hospital
- English speaking
- Have not yet had their primary breast cancer surgery
Who cannot join
None listed.
About this study
The overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective
- Conduct short in-person interviews with young women prior to surgery
- Conduct focus groups with breast cancer survivors about their surgical decision and experience
- Interview surgical oncologists, plastic surgeons, medical and radiation oncologists about their experiences and how they communicate with breast cancer patients about local therapy decisions
- To survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.
Read the detailed description
Breast cancer in young women: Breast cancer is the most common cancer diagnosed in women younger than age 40 in the United States, with approximately 14,000 new cases each year. Young women face unique psychosocial challenges, most notably fertility, sexuality, and image concerns and are at a life stage where education, career, and family are important priorities. Concern about these issues may contribute to the greater psychosocial distress seen in younger women at both diagnosis and in follow-up compared with older women. Importantly, these concerns may also influence treatment decisions including receipt of chemotherapy, adherence to endocrine therapy, and surgical decisions. Thus, attending to the unique issues of young women may enhance not only quality of care and quality of life (QOL) but also potentially disease outcomes.
Surgical management of breast cancer: Standard loco-regional management of breast cancer entails partial mastectomy (i.e., breast conserving surgery) followed by radiation or mastectomy with or without radiation. The decision depends on a number of factors including extent of disease, family history, BRCA mutation status, and personal preference. In recent years, an increasing number of women have elected to undergo contralateral prophylactic mastectomy (CPM) in conjunction with surgery of the affected breast (usually choosing bilateral mastectomy), despite a lack of clear evidence for survival benefit from this procedure in the vast majority of women. In weighing the benefits and risks of CPM, one must consider the absolute risk reduction of a new primary breast cancer (usually relatively modest in the average risk survivor), the long and short-term risks of this additional surgery including potential complications (bilateral mastectomy is associated with a greater risk of surgical complications) and the impact on QOL. At the same time, one must consider the competing risk of systemic recurrence of a woman's initial breast cancer. Young women, in particular, have the greatest risk of systemic recurrence and death from their original cancer, lowering the likelihood of benefit of CPM in preventing a new primary breast cancer. However, while CPM rates have increased among all breast cancer patients, increased rates of CPM are particularly pronounced among the youngest women with breast cancer, with several studies identifying young age at diagnosis as one of the strongest determinants of CPM.Physicians and researchers have been observing and discussing this trend for a number of years and yet little has been done to intervene.
The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision. Based on these findings, the investigators will determine how to best improve the quality of the process, e.g., by correcting misperceptions, setting realistic expectations regarding the impact of surgery (including reconstruction) on QOL, improving communication with health care providers, and better management of anxiety surrounding diagnosis. This qualitative research is designed to build on prior quantitative analyses, by gaining an in depth perspective through focus groups and interviews, about certain issues identified as impacting the surgical decision process, including anxiety, fear of recurrence, and patient-physician communication.
Collectively, results from the qualitative assessment will inform a future phase of this research involving the design and subsequent development of a decision aid to help women make informed decisions about their breast cancer surgery.
The goal of this second phase of the research is to survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- qualitative data collection, survey, decision aid
- Keywords
- breast cancer, decision making, surgery, qualitative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative data collectionOther
qualitative data collection
surveyOther
survey pre and post-surgical consult
decision aidOther
web-based decision aid post-surgical consult
| Study group | Role | What they receive |
|---|---|---|
| Key Informant interviews | 20 in-person or phone qualitative interviews with patients. Receives: Other: qualitative data collection | |
| Focus Groups | four qualitative focus groups of 6-10 women each. Receives: Other: qualitative data collection | |
| Physician Interviews | physician qualitative interviews over the telephone. Receives: Other: qualitative data collection | |
| Usual care cohort (pilot) | 50 women who will be surveyed before and after their surgical consult Receives: Other: survey | |
| Decision aid cohort (pilot) | 50 women who will be surveyed before and after their surgical consult and will also be sent a web-based decision aid Receives: Other: survey; Other: decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic summary from the data gathered from the use of a moderator guide (series of probing questions) that inquires about the experiences surrounding the surgical decision-making process from both the patient and physician perspective
The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision.
Measured: 1 year
Breast cancer knowledge
Knowledge will be assessed using selected questions from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions as well as additional true/false questions related to side effects of radiation.
Measured: 2 weeks
Decisional conflict
Decisional conflict will be measured with the SURE scale. The SURE scale is composed of four items from the Decisional Conflict Scale that measure patients' uncertainty about which treatment choice and factors contributing to uncertainty.
Measured: 2 weeks
Anxiety
Anxiety will be assessed using the PROMIS Emotional Distress - Anxiety - Short Form.
Measured: 2 weeks
Treatment goals and preferences
have been adapted from the BCS-DQI. We will ask women to mark on a scale (not important - very important) the importance of several reasons in relation to their decision about surgery as well as concerns (not all concerned-very concerned) about local therapy.
Measured: 2 weeks
Perception of decision process
Perception of the decision process will be assessed with an adapted version of the Control Preferences Scale.
Measured: 2 weeks
Secondary outcomes (1)
Usability of decision aid (DA)
Assessment of what patients did and did not like about the DA, ways they think the DA can be improved, and how they felt the DA affected communication with their physician.
Measured: 2 weeks-1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start19 Feb 2016
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
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 Dana-Farber Cancer InstituteThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Shoshana M. Rosenberg, Dana-Farber Cancer Institute
- Investigators
- Shoshana Rosenberg, ScD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644382
- Sponsor's protocol ID
- 15-288
- Other IDs
- 1K01HS023680-01A1
- Status last verified
- Jun 2020
- First submitted
- 20 Dec 2015
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenberg SM, Greaney ML, Patenaude AF, Sepucha KR, Meyer ME, Partridge AH. "I don't want to take chances.": A qualitative exploration of surgical decision making in young breast cancer survivors. Psychooncology. 2018 Jun;27(6):1524-1529. doi: 10.1002/pon.4683. Epub 2018 Apr 6.
PubMed 29476578Rosenberg SM, Greaney ML, Patenaude AF, Partridge AH. Factors Affecting Surgical Decisions in Newly Diagnosed Young Women with Early-Stage Breast Cancer. J Adolesc Young Adult Oncol. 2019 Aug;8(4):463-468. doi: 10.1089/jayao.2019.0002. Epub 2019 Apr 3.
PubMed 30942651
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Decision-making in Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02644382
- Acronym / sponsor ID
- 15-288
- Conditions
- Breast Cancer
- Keywords
- breast cancer, decision making, surgery, qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 31 Dec 2015 (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 overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective
- Conduct short in-person interviews with young women prior to surgery
- Conduct focus groups with breast cancer survivors about their surgical decision and experience
- Interview surgical oncologists, plastic surgeons, medical and radiation oncologists about their experiences and how they communicate with breast cancer patients about local therapy decisions
- To survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.
Detailed description
Breast cancer in young women: Breast cancer is the most common cancer diagnosed in women younger than age 40 in the United States, with approximately 14,000 new cases each year. Young women face unique psychosocial challenges, most notably fertility, sexuality, and image concerns and are at a life stage where education, career, and family are important priorities. Concern about these issues may contribute to the greater psychosocial distress seen in younger women at both diagnosis and in follow-up compared with older women. Importantly, these concerns may also influence treatment decisions including receipt of chemotherapy, adherence to endocrine therapy, and surgical decisions. Thus, attending to the unique issues of young women may enhance not only quality of care and quality of life (QOL) but also potentially disease outcomes.
Surgical management of breast cancer: Standard loco-regional management of breast cancer entails partial mastectomy (i.e., breast conserving surgery) followed by radiation or mastectomy with or without radiation. The decision depends on a number of factors including extent of disease, family history, BRCA mutation status, and personal preference. In recent years, an increasing number of women have elected to undergo contralateral prophylactic mastectomy (CPM) in conjunction with surgery of the affected breast (usually choosing bilateral mastectomy), despite a lack of clear evidence for survival benefit from this procedure in the vast majority of women. In weighing the benefits and risks of CPM, one must consider the absolute risk reduction of a new primary breast cancer (usually relatively modest in the average risk survivor), the long and short-term risks of this additional surgery including potential complications (bilateral mastectomy is associated with a greater risk of surgical complications) and the impact on QOL. At the same time, one must consider the competing risk of systemic recurrence of a woman's initial breast cancer. Young women, in particular, have the greatest risk of systemic recurrence and death from their original cancer, lowering the likelihood of benefit of CPM in preventing a new primary breast cancer. However, while CPM rates have increased among all breast cancer patients, increased rates of CPM are particularly pronounced among the youngest women with breast cancer, with several studies identifying young age at diagnosis as one of the strongest determinants of CPM.Physicians and researchers have been observing and discussing this trend for a number of years and yet little has been done to intervene.
The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision. Based on these findings, the investigators will determine how to best improve the quality of the process, e.g., by correcting misperceptions, setting realistic expectations regarding the impact of surgery (including reconstruction) on QOL, improving communication with health care providers, and better management of anxiety surrounding diagnosis. This qualitative research is designed to build on prior quantitative analyses, by gaining an in depth perspective through focus groups and interviews, about certain issues identified as impacting the surgical decision process, including anxiety, fear of recurrence, and patient-physician communication.
Collectively, results from the qualitative assessment will inform a future phase of this research involving the design and subsequent development of a decision aid to help women make informed decisions about their breast cancer surgery.
The goal of this second phase of the research is to survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Key Informant interviews | – | Other: qualitative data collection20 in-person or phone qualitative interviews with patients. |
| Focus Groups | – | Other: qualitative data collectionfour qualitative focus groups of 6-10 women each. |
| Physician Interviews | – | Other: qualitative data collectionphysician qualitative interviews over the telephone. |
| Usual care cohort (pilot) | – | Other: survey50 women who will be surveyed before and after their surgical consult |
| Decision aid cohort (pilot) | – | Other: survey, Other: decision aid50 women who will be surveyed before and after their surgical consult and will also be sent a web-based decision aid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young Women with a history of breast cancer and providers who care for them.
Key inclusion criteria (18 listed)
- Patients for key informant interviews-
- Newly diagnosed women with Stage 0-3 breast cancer
- Between the ages of 18 and 40 who are seen at DFCI and have not yet had their primary breast cancer surgery.
- diagnosis of Stage 0-3 breast cancer at age 40 and younger
- currently between the ages of 18-43
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 |
|---|---|---|
| qualitative data collectionqualitative data collection | Other | Focus Groups, Key Informant interviews, Physician Interviews |
| surveysurvey pre and post-surgical consult | Other | Decision aid cohort (pilot), Usual care cohort (pilot) |
| decision aidweb-based decision aid post-surgical consult | Other | Decision aid cohort (pilot) |
Primary outcome
Thematic summary from the data gathered from the use of a moderator guide (series of probing questions) that inquires about the experiences surrounding the surgical decision-making process from both the patient and physician perspective
Time frame: 1 year
The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision.
Breast cancer knowledge
Time frame: 2 weeks
Knowledge will be assessed using selected questions from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions as well as additional true/false questions related to side effects of radiation.
Decisional conflict
Time frame: 2 weeks
Decisional conflict will be measured with the SURE scale. The SURE scale is composed of four items from the Decisional Conflict Scale that measure patients' uncertainty about which treatment choice and factors contributing to uncertainty.
Anxiety
Time frame: 2 weeks
Anxiety will be assessed using the PROMIS Emotional Distress - Anxiety - Short Form.
Treatment goals and preferences
Time frame: 2 weeks
have been adapted from the BCS-DQI. We will ask women to mark on a scale (not important - very important) the importance of several reasons in relation to their decision about surgery as well as concerns (not all concerned-very concerned) about local therapy.
Perception of decision process
Time frame: 2 weeks
Perception of the decision process will be assessed with an adapted version of the Control Preferences Scale.
1 secondary outcome
Usability of decision aid (DA)
Time frame: 2 weeks-1 month
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 29 Jun 2020.
- Background: PubMed 29476578Rosenberg SM, Greaney ML, Patenaude AF, Sepucha KR, Meyer ME, Partridge AH. "I don't want to take chances.": A qualitative exploration of surgical decision making in young breast cancer survivors. Psychooncology. 2018 Jun;27(6):1524-1529. doi: 10.1002/pon.4683. Epub 2018 Apr 6.
- Background: PubMed 30942651Rosenberg SM, Greaney ML, Patenaude AF, Partridge AH. Factors Affecting Surgical Decisions in Newly Diagnosed Young Women with Early-Stage Breast Cancer. J Adolesc Young Adult Oncol. 2019 Aug;8(4):463-468. doi: 10.1089/jayao.2019.0002. Epub 2019 Apr 3.
- 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.
Shoshana Rosenberg, ScD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute.
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 18 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 29 Jun 2020. 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?
Thematic summary from the data gathered from the use of a moderator guide (series of probing questions) that inquires about the experiences surrounding the surgical decision-making process from both the patient and physician perspective (time frame: 1 year). The study lists 6 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 NCT02644382, 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 29 Jun 2020.