Improving Surgical Decision-making in Young Women With Breast Cancer

NCT02644382 | Completed

• 2 other identifiers: 15-2881K01HS023680-01A1
• Study Type: observational
• Target: 145
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective

1. 1.Conduct short in-person interviews with young women prior to surgery
2. 2.Conduct focus groups with breast cancer survivors about their surgical decision and experience
3. 3.Interview surgical oncologists, plastic surgeons, medical and radiation oncologists about their experiences and how they communicate with breast cancer patients about local therapy decisions
4. 4.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

Keywords

breast cancer; decision making; surgery; qualitative

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  2 weeks

• Anxiety

  Anxiety will be assessed using the PROMIS Emotional Distress - Anxiety - Short Form.

  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.

  2 weeks

• Perception of decision process

  Perception of the decision process will be assessed with an adapted version of the Control Preferences Scale.

  2 weeks

Secondary Outcomes (1)

• Usability of decision aid (DA)

  2 weeks-1 month

Study Arms (5)

Key Informant interviews

20 in-person or phone qualitative interviews with patients.

Other: qualitative data collection

Focus Groups

four qualitative focus groups of 6-10 women each.

Other: qualitative data collection

Physician Interviews

physician qualitative interviews over the telephone.

Other: qualitative data collection

Usual care cohort (pilot)

50 women who will be surveyed before and after their surgical consult

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

Other: survey; Other: decision aid

Interventions

qualitative data collection OTHER

qualitative data collection

Focus Groups; Key Informant interviews; Physician Interviews

survey OTHER

survey pre and post-surgical consult

Decision aid cohort (pilot); Usual care cohort (pilot)

decision aid OTHER

web-based decision aid post-surgical consult

Decision aid cohort (pilot)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young Women with a history of breast cancer and providers who care for them.

You may qualify if:

• 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
• English-speaking
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Related Publications (2)

• 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.

  PMID: 29476578 BACKGROUND

• Rosenberg 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.

  PMID: 30942651 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires; Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Shoshana Rosenberg, ScD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 31, 2015
• Study Start: February 19, 2016
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share