What Matters Most: Choosing the Right Breast Cancer Surgery for You

NCT03136367 | Completed Results DMC

• 1 other identifier: D17063
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 5

Brief Summary

What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES.

Conditions

Breast Cancer

Keywords

encounter decision aids; shared decision making; socioeconomic status; disparities; decision quality

Outcome Measures

Primary Outcomes (3)

• Change in Decision Quality: Knowledge Subscale

  Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference.

  Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery

• Change in Decision Quality: Decison Process Subscale

  Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale from 0 to 7 with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance score indicated the percentage of patients who received a treatment that matched their stated preference.

  Immediately after the index surgical consultation visit and at one week post-surgery

• Change in Decision Quality: Concordance Subscale

  Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference at T2 (lumpectomy vs mastectomy).

  Immediately after the index surgical consultation visit and at one week post-surgery

Secondary Outcomes (8)

• Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice

  1 week post-surgery

• Change in Quality of Life

  Immediately before the index surgical consultation visit and at 12 weeks post-surgery

• Anxiety

  Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgery

• Shared Decision-making (Self-reported)

  Immediately after the index surgical consultation visit

• Shared Decision-making (Observed)

  During the index surgical consultation visit

Study Arms (3)

Arm 1: Option Grid

EXPERIMENTAL

Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.

Other: Option Grid

Arm 2: Picture Option Grid

EXPERIMENTAL

Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.

Other: Picture Option Grid

Arm 3: Usual Care

NO INTERVENTION

In the usual care arm, surgeons provided their standard information about breast cancer

Interventions

Option Grid OTHER

The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.

Also known as: Option Grid for Breast Cancer Surgery, Breast cancer: surgical options

Arm 1: Option Grid

Picture Option Grid OTHER

The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.

Also known as: Early-stage breast cancer: What's right for me?

Arm 2: Picture Option Grid

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In order to be in this trial, participants must have been assigned female at birth. Transgender men will also be excluded as their treatment course would be managed on a case-by-case basis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Assigned female at birth;
• years and older;
• Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);
• Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;
• Spoken English, Spanish, or Mandarin Chinese.

You may not qualify if:

• Transgender men and women;
• Women who have undergone prophylactic mastectomy;
• Women with visual impairment;
• Women with a diagnosis of severe mental illness or severe dementia;
• Women with inflammatory breast carcinoma.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Washington University School of Medicine: collaborator
• Montefiore Medical Center: collaborator
• NYU Langone Health: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (14)

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  PMID: 25142035 BACKGROUND

• Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.

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• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.

  PMID: 24389354 BACKGROUND

• Barr PJ, O'Malley AJ, Tsulukidze M, Gionfriddo MR, Montori V, Elwyn G. The psychometric properties of Observer OPTION(5), an observer measure of shared decision making. Patient Educ Couns. 2015 Aug;98(8):970-6. doi: 10.1016/j.pec.2015.04.010. Epub 2015 Apr 29.

  PMID: 25956069 BACKGROUND

• Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

  PMID: 23768763 BACKGROUND

• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

  PMID: 12926578 BACKGROUND

• Elwyn G, Thompson R, John R, Grande SW. Developing IntegRATE: a fast and frugal patient-reported measure of integration in health care delivery. Int J Integr Care. 2015 Mar 27;15:e008. doi: 10.5334/ijic.1597. eCollection 2015 Jan-Mar.

  PMID: 26034467 BACKGROUND

• Pickard AS, De Leon MC, Kohlmann T, Cella D, Rosenbloom S. Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Med Care. 2007 Mar;45(3):259-63. doi: 10.1097/01.mlr.0000254515.63841.81.

  PMID: 17304084 BACKGROUND

• Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

  PMID: 21697139 BACKGROUND

• Sepucha KR, Belkora JK, Chang Y, Cosenza C, Levin CA, Moy B, Partridge A, Lee CN. Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery. BMC Med Inform Decis Mak. 2012 Jun 8;12:51. doi: 10.1186/1472-6947-12-51.

  PMID: 22681763 BACKGROUND

• Schubbe D, Yen RW, Saunders CH, Elwyn G, Forcino RC, O'Malley AJ, Politi MC, Margenthaler J, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bradley A, Goodwin C, van den Muijsenbergh M, Aarts JWM, Scalia P, Durand MA. Implementation and sustainability factors of two early-stage breast cancer conversation aids in diverse practices. Implement Sci. 2021 May 10;16(1):51. doi: 10.1186/s13012-021-01115-1.

  PMID: 33971913 DERIVED

• Durand MA, Yen RW, O'Malley AJ, Schubbe D, Politi MC, Saunders CH, Dhage S, Rosenkranz K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, Walling L, Marx CM, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bergin E, Goodwin C, Miller C, Harris C, Barth RJ Jr, Aft R, Feldman S, Cyr AE, Angeles CV, Jiang S, Elwyn G. What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata. Cancer. 2021 Feb 1;127(3):422-436. doi: 10.1002/cncr.33248. Epub 2020 Nov 10.

  PMID: 33170506 DERIVED

• Durand MA, Yen RW, O'Malley AJ, Politi MC, Dhage S, Rosenkranz K, Weichman K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Song J, Acosta J, Mir N, Elwyn G. What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata. BMC Public Health. 2018 Feb 13;18(1):241. doi: 10.1186/s12889-018-5109-2.

  PMID: 29439691 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marie-Anne Durand
• Organization: Dartmouth College

marie-anne.durand@dartmouth.edu

603-667-8601

Study Officials

• Marie-Ann Durand, MSc, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will be blinded to the clinician randomization.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm randomized controlled superiority trial with stratification by SES and randomization at the clinician level. Patient enrollment will occur at five cancer centers in the United States. Patients will be enrolled in one of the three arms based on the clinician they are seeing as a part of their care.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 2, 2017
• Study Start: September 18, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)