Breast CancerNCT03136367
What Matters Most: Choosing the Right Breast Cancer Surgery for You
A study testing Option Grid and Picture Option Grid in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Option Grid and Picture Option Grid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Sep 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assigned female at birth;
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Bellevue Hospital Center
New York, New York, 10016
NYU Langone Medical Center
New York, New York, 10016
Washington University in St. Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
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.
Read the detailed description
Background and Significance
Breast cancer is the most commonly diagnosed malignancy in women. Despite improvements in survival, women of low socioeconomic status (SES) diagnosed with early stage breast cancer:
- Continue to experience poorer doctor-patient communication, lower satisfaction with surgery and decision making, and higher decision regret compared to women of higher SES;
- Often play a passive role in decision making;
- Are less likely to undergo breast-conserving surgery (BCS);
- Are less likely to receive optimal care.
Those differences are disparities that predominantly affect women of low SES with early stage breast cancer, irrespective of race or ethnicity. For early stage breast cancer, low SES is a stronger predictor of poorer outcomes, treatment received and death, than race or ethnicity. The investigators define low SES as a lower income, lower educational attainment, and uninsured or state-insured status
Although BCS is the recommended treatment for early stage breast cancer (stages I to IIIA), research confirms equivalent survival between mastectomy and BCS. Both options are offered yet have distinct harms and benefits, valued differently by patients. The patient and stakeholder partners involved in this study have emphasized the critical importance of supporting women in making high quality breast cancer surgery decisions (good knowledge and alignment between the patient's choice, values and priorities) irrespective of SES and health literacy. Yet, research shows that women of low SES are not usually involved in an informed, patient-centered dialogue about surgery choice. There is no evidence that women of low SES have distinct preferences that explain a lower uptake of BCS and limited engagement in decision making. Further, communication strategies are not typically adapted to women of low SES and low health literacy. Most decision aids for breast cancer have been designed for highly literate audiences, with poor accessibility and readability. Simpler, shorter decision aids delivered in the clinical encounter (encounter decision aids) may be more beneficial to underserved patients, and could reduce disparities. It is critical to determine how to effectively support women of low SES in making informed breast cancer surgery choices.
Study Aims
First, the investigators will assess the comparative effectiveness of two effective encounter decision aids (Option Grid and Picture Option Grid) against usual care on decision quality (primary outcome), shared decision making, treatment choice and other secondary outcomes across socioeconomic strata (Aim 1). Second, the investigators aim to explore the effect of the Picture Option Grid on disparities in decision making (decision quality, knowledge, and shared decision making), treatment choice, as well as mediation and moderation effects (Aim 2). Third, in order to maximize the implementation potential, the investigators will explore strategies that promote the encounter decision aids' sustained use and dissemination using a theoretical implementation model (Aim 3).
Study Description
The investigators will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES (Aims 1 and 2) and randomization at the clinician level. One thousand, one hundred patients (half of higher SES and half of lower SES) will be recruited from five large cancer centers. In preparation for the trial (Year 01), the investigators will conduct semi-structured interviews with women of low SES who have completed treatment for early stage breast cancer to adapt the "What Matters Most to You" subscale of the Decision Quality Instrument (DQI) for women of low SES. Lastly, the investigators will use interviews, field-notes, and observations to explore strategies that promote the interventions' sustained use and dissemination using the Normalization Process Theory (Aim 3). Community-Based Participatory Research will be used throughout the trial (with continuous patient and stakeholder involvement).
Women 18 years and older with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES will be included in the trial, provided they have a basic command of English, Spanish, or Mandarin. About 367 patients will be recruited per arm.
Both interventions have been developed, tested, and shown to be effective. The Option Grid (intervention 1) is a one-page evidence-based summary of available options presented in a tabular format, listing the trade-offs that patients normally consider when making breast cancer surgery decisions. The Picture Option Grid (intervention 2) uses the same evidence and tabular layout, but it is tailored to women of lower SES and low health literacy and includes simple text and images. Because decision aids are not routinely available in real world settings, usual care is a coherent and legitimate comparator. It will include the provision of usual information resources about breast cancer but will exclude the provision of other decision aids.
Secondary outcome measures will include treatment choice, the validated 3-item CollaboRATE measure of shared decision-making (SDM), Chew's validated one-item health literacy screening question, PROMIS, an 8-item validated anxiety short form, EQ-5D-5L, a validated, standardized 6-item quality of life measure, and four items from COST, a validated financial toxicity measure. Participants will also be asked to estimate their out-of-pocket expenses over the past month. All measures will be available in English, Spanish, and Mandarin. Observer OPTION5 will be used to rate the level of shared decision making in the clinical encounter.
A regression framework (logistic regression, linear regression, mixed effect regression models, generalized estimating equations) and mediation analyses will be used in the analysis. The investigators will also use multiple informants analysis to measure and examine SES and multiple imputation to manage missing data. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. The investigators will also use the recordings of surgical consultations to analyze the conversations about costs and treatment recommendations made by providers.
- Conditions
- Breast Cancer
- Being tested
- Option Grid, Picture Option Grid
- Keywords
- encounter decision aids, shared decision making, socioeconomic status, disparities, decision quality
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Option GridOther
Also called Option Grid for Breast Cancer Surgery, Breast cancer: surgical options
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.
Picture Option GridOther
Also called Early-stage breast cancer: What's right for me?
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Picture Option Grid |
| Arm 3: Usual Care | No intervention | In the usual care arm, surgeons provided their standard information about breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery)
Measured: 1 week post-surgery
Change in Quality of Life
Quality of life reported by the patient measured using the validated 6-item EQ-5D-5L measure. We used the available resources from EuroQol to convert EQ-5D-5L states into an index value, using the EQ-5D-5L crosswalk value sets. Index values ranged from full health (1) and to no health (-0.109), according to the US crosswalk value set.
Measured: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Anxiety
Patient-reported anxiety, measured using the validated 8-item PROMIS anxiety short form. Each question was coded from one to five. Total scores were obtained by scoring the raw score of each item answered. The lowest possible raw score was 8; the highest possible raw score was 40 with higher numbers indicating higher anxiety.
Measured: 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)
Self-reported shared decision-making about breast cancer surgical options measured using the validated 3-item CollaboRATE measure. Each item was rated on a scale from 0 to 9 with a possible score range from 0 to 27. We dichotomized this measure using the top score approach, grouping participants scoring 9 on all three items versus all others.
Measured: Immediately after the index surgical consultation visit
Shared Decision-making (Observed)
Shared decision-making observed during the surgical consultation, measured using the validated observer-rated OPTION5. The five items on the measure ask raters to score the consultation on how much the clinician: 1) confirms that alternatives exist, 2) reassures that they will support the patient to become informed, 3) gives information or checks understanding about the options, 4) makes an effort to elicit the patient's preferences, and 5) integrates the patient's elicited preferences. Each of the five items is scored from zero to four for a summary score ranging from zero to 20 and a scaled score ranging from zero to 100. Higher numbers indicate more shared decision making was observed.
Measured: During the index surgical consultation visit
Decision Regret
Patient-reported feelings of decision regret, measured using the validated 5-item decision regret scale. Items 2 and 4 were reverse coded so a higher number indicated more regret. Scores were then converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items were summed and averaged. A score of 0 meant no regret and a score of 100 meant high regret.
Measured: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery
Integration of Health Care Delivery
Patient-reported measure of integration of healthcare delivery, measured using IntegRATE, a 4-item scale. IntegRATE sum scores are determined by summing each participant's scores across the 4 items (range 0-12). A higher score indicates higher integration.
Measured: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Semi-structured interviews with clinic stakeholders and patients 12 weeks post-surgery, field notes, and clinic observations to explore strategies that promote the interventions' sustained use and dissemination
Measured: 12 weeks post-surgery (patients) or after trial participation ended (surgeons)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start18 Sep 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)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 Dartmouth-Hitchcock 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Montefiore Medical Center, NYU Langone Health, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Marie-Anne Durand, Dartmouth-Hitchcock Medical Center
- Investigators
- Marie-Ann Durand, MSc, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136367
- Sponsor's protocol ID
- D17063
- Status last verified
- Dec 2020
- First submitted
- 25 Apr 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee CN, Wetschler MH, Chang Y, Belkora JK, Moy B, Partridge A, Sepucha KR. Measuring decision quality: psychometric evaluation of a new instrument for breast cancer chemotherapy. BMC Med Inform Decis Mak. 2014 Aug 20;14:73. doi: 10.1186/1472-6947-14-73.
PubMed 25142035Chew 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.
PubMed 18335281Herdman 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.
PubMed 21479777Barr 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.
PubMed 24389354Barr 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.
PubMed 25956069Elwyn 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.
PubMed 23768763Brehaut 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.
PubMed 12926578Elwyn 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.
PubMed 26034467Pickard 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.
PubMed 17304084Pilkonis 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.
PubMed 21697139Sepucha 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.
PubMed 22681763Schubbe 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.
PubMed 33971913Durand 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.
PubMed 33170506Durand 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.
PubMed 29439691
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
- ClinicalTrials.gov ID
- NCT03136367
- Acronym / sponsor ID
- D17063
- Conditions
- Breast Cancer
- Keywords
- encounter decision aids, shared decision making, socioeconomic status, disparities, decision quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Montefiore Medical Center, NYU Langone Health, Patient-Centered Outcomes Research Institute
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Significance
Breast cancer is the most commonly diagnosed malignancy in women. Despite improvements in survival, women of low socioeconomic status (SES) diagnosed with early stage breast cancer:
- Continue to experience poorer doctor-patient communication, lower satisfaction with surgery and decision making, and higher decision regret compared to women of higher SES;
- Often play a passive role in decision making;
- Are less likely to undergo breast-conserving surgery (BCS);
- Are less likely to receive optimal care.
Those differences are disparities that predominantly affect women of low SES with early stage breast cancer, irrespective of race or ethnicity. For early stage breast cancer, low SES is a stronger predictor of poorer outcomes, treatment received and death, than race or ethnicity. The investigators define low SES as a lower income, lower educational attainment, and uninsured or state-insured status
Although BCS is the recommended treatment for early stage breast cancer (stages I to IIIA), research confirms equivalent survival between mastectomy and BCS. Both options are offered yet have distinct harms and benefits, valued differently by patients. The patient and stakeholder partners involved in this study have emphasized the critical importance of supporting women in making high quality breast cancer surgery decisions (good knowledge and alignment between the patient's choice, values and priorities) irrespective of SES and health literacy. Yet, research shows that women of low SES are not usually involved in an informed, patient-centered dialogue about surgery choice. There is no evidence that women of low SES have distinct preferences that explain a lower uptake of BCS and limited engagement in decision making. Further, communication strategies are not typically adapted to women of low SES and low health literacy. Most decision aids for breast cancer have been designed for highly literate audiences, with poor accessibility and readability. Simpler, shorter decision aids delivered in the clinical encounter (encounter decision aids) may be more beneficial to underserved patients, and could reduce disparities. It is critical to determine how to effectively support women of low SES in making informed breast cancer surgery choices.
Study Aims
First, the investigators will assess the comparative effectiveness of two effective encounter decision aids (Option Grid and Picture Option Grid) against usual care on decision quality (primary outcome), shared decision making, treatment choice and other secondary outcomes across socioeconomic strata (Aim 1). Second, the investigators aim to explore the effect of the Picture Option Grid on disparities in decision making (decision quality, knowledge, and shared decision making), treatment choice, as well as mediation and moderation effects (Aim 2). Third, in order to maximize the implementation potential, the investigators will explore strategies that promote the encounter decision aids' sustained use and dissemination using a theoretical implementation model (Aim 3).
Study Description
The investigators will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES (Aims 1 and 2) and randomization at the clinician level. One thousand, one hundred patients (half of higher SES and half of lower SES) will be recruited from five large cancer centers. In preparation for the trial (Year 01), the investigators will conduct semi-structured interviews with women of low SES who have completed treatment for early stage breast cancer to adapt the "What Matters Most to You" subscale of the Decision Quality Instrument (DQI) for women of low SES. Lastly, the investigators will use interviews, field-notes, and observations to explore strategies that promote the interventions' sustained use and dissemination using the Normalization Process Theory (Aim 3). Community-Based Participatory Research will be used throughout the trial (with continuous patient and stakeholder involvement).
Women 18 years and older with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES will be included in the trial, provided they have a basic command of English, Spanish, or Mandarin. About 367 patients will be recruited per arm.
Both interventions have been developed, tested, and shown to be effective. The Option Grid (intervention 1) is a one-page evidence-based summary of available options presented in a tabular format, listing the trade-offs that patients normally consider when making breast cancer surgery decisions. The Picture Option Grid (intervention 2) uses the same evidence and tabular layout, but it is tailored to women of lower SES and low health literacy and includes simple text and images. Because decision aids are not routinely available in real world settings, usual care is a coherent and legitimate comparator. It will include the provision of usual information resources about breast cancer but will exclude the provision of other decision aids.
Secondary outcome measures will include treatment choice, the validated 3-item CollaboRATE measure of shared decision-making (SDM), Chew's validated one-item health literacy screening question, PROMIS, an 8-item validated anxiety short form, EQ-5D-5L, a validated, standardized 6-item quality of life measure, and four items from COST, a validated financial toxicity measure. Participants will also be asked to estimate their out-of-pocket expenses over the past month. All measures will be available in English, Spanish, and Mandarin. Observer OPTION5 will be used to rate the level of shared decision making in the clinical encounter.
A regression framework (logistic regression, linear regression, mixed effect regression models, generalized estimating equations) and mediation analyses will be used in the analysis. The investigators will also use multiple informants analysis to measure and examine SES and multiple imputation to manage missing data. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. The investigators will also use the recordings of surgical consultations to analyze the conversations about costs and treatment recommendations made by providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Option Grid | Experimental | Other: Option GridPatients 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. |
| Arm 2: Picture Option Grid | Experimental | Other: Picture Option GridPatients 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. |
| Arm 3: Usual Care | No intervention | –In the usual care arm, surgeons provided their standard information about breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Assigned female at birth;
- 18 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Option GridAlso: Option Grid for Breast Cancer Surgery, Breast cancer: surgical optionsThe 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. | Other | Arm 1: Option Grid |
| Picture Option GridAlso: Early-stage breast cancer: What's right for me?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. | Other | Arm 2: Picture Option Grid |
Primary outcome
Change in Decision Quality: Knowledge Subscale
Time frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery
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.
Change in Decision Quality: Decison Process Subscale
Time frame: Immediately after the index surgical consultation visit and at one week post-surgery
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.
Change in Decision Quality: Concordance Subscale
Time frame: Immediately after the index surgical consultation visit and at one week post-surgery
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).
8 secondary outcomes
Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice
Time frame: 1 week post-surgery
Change in Quality of Life
Time frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Anxiety
Time frame: 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)
Time frame: Immediately after the index surgical consultation visit
Shared Decision-making (Observed)
Time frame: During the index surgical consultation visit
Decision Regret
Time frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery
Integration of Health Care Delivery
Time frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Time frame: 12 weeks post-surgery (patients) or after trial participation ended (surgeons)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25142035Lee CN, Wetschler MH, Chang Y, Belkora JK, Moy B, Partridge A, Sepucha KR. Measuring decision quality: psychometric evaluation of a new instrument for breast cancer chemotherapy. BMC Med Inform Decis Mak. 2014 Aug 20;14:73. doi: 10.1186/1472-6947-14-73.
- Background: PubMed 18335281Chew 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.
- Background: PubMed 21479777Herdman 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.
- Background: PubMed 24389354Barr 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.
- Background: PubMed 25956069Barr 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.
- Background: PubMed 23768763Elwyn 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.
- Background: PubMed 12926578Brehaut 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.
- Background: PubMed 26034467Elwyn 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.
- Background: PubMed 17304084Pickard 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.
- Background: PubMed 21697139Pilkonis 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.
- Background: PubMed 22681763Sepucha 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.
- Derived from this study: PubMed 33971913Schubbe 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.
- 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.
Marie-Ann Durand, MSc, PhD principal investigator
Dartmouth-Hitchcock Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Option Grid and Picture Option Grid in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 5 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 5 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Decision Quality: Knowledge Subscale (time frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery). 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?
On the ClinicalTrials.gov record for NCT03136367, which also lists 14 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 5 Jan 2021.