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Trial record 1 of 1 for:    NCT03136367
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What Matters Most: Choosing the Right Breast Cancer Surgery for You

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ClinicalTrials.gov Identifier: NCT03136367
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Washington University School of Medicine
Montefiore Medical Center
NYU Langone Health
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Marie-Anne Durand, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE April 25, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE September 18, 2017
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
Change in decision quality [ 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 (Sepucha et al., 2012)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • Health literacy [ Time Frame: Immediately before the index surgical consultation visit ]
    Health literacy measured using Chew's 1-item health literacy screening (Chew et al., 2008)
  • Treatment choice [ Time Frame: 1 week post-surgery ]
    Treatment choice, or which surgical or treatment option the patient chose
  • Change in quality of life [ Time Frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery ]
    Quality of life reported by the patient measured using the validated 6-item EQ-5D-5L measure (Herdman et al., 2011; Pickard et al., 2007)
  • Knowledge [ Time Frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, and at 1 week post-surgery ]
    Knowledge of surgical options, measured using the validated 5-item knowledge sub-scale on the Decision Quality Worksheet (Sepucha et al., 2012)
  • 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 ]
    Patient-reported anxiety, measured using the validated 8-item PROMIS anxiety short form (Pilkonis et al, 2011)
  • Shared decision-making (self-reported) [ Time Frame: Immediately after the index surgical consultation visit ]
    Self-reported shared decision-making about breast cancer surgical options measured using the validated 3-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013)
  • Shared decision-making (observed) [ Time Frame: During the index surgical consultation visit ]
    Shared decision-making observed during the surgical consultation, measured using the validated observer-rated OPTION5 (Barr et al., 2015)
  • Decision regret [ Time Frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery ]
    Patient-reported feelings of decision regret, measured using the validated 5-item decision regret scale (Brehaut et al., 2003)
  • Integration of health care delivery [ Time Frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery ]
    Patient-reported measure of integration of healthcare delivery, measured using IntegRATE (Elwyn et al., 2015)
  • Financial toxicity [ Time Frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery ]
    Patient-reported measure of financial toxicity, or financial distress, as a result of their cancer diagnosis, measured by 4 items from COST (de Souza et al., 2014; de Souza et al., 2017) and self-reported out-of-pocket expenses incurred as a result of the patient's cancer diagnosis
  • Intervention's pattern of use [ Time Frame: Immediately after the index surgical consultation visit and at 1 week post surgery ]
    Determination of how the Option Grid and Picture Option Grid have been used in the surgical consultation and between the surgical consultation and surgery occurring, measured by taking pictures of the interventions immediately after the surgical consultation and asking participants to indicate how many times they (or their caregivers, family members, or relatives) have used the intervention post-surgical consultation
  • Exploration of strategies that promote the interventions' sustained use and dissemination [ Time Frame: Immediately before the index surgical consultation visit, during the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgery ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • Health literacy [ Time Frame: Immediately before the index surgical consultation visit ]
    Health literacy measured using Chew's 1-item health literacy screening (Chew et al., 2008)
  • Treatment choice [ Time Frame: 1 week post-surgery ]
    Treatment choice, or which surgical or treatment option the patient chose
  • Quality of life [ Time Frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery ]
    Quality of life reported by the patient measured using the validated 6-item EQ-5D-5L measure (Herdman et al., 2011; Pickard et al., 2007)
  • Knowledge [ Time Frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, and at 1 week post-surgery ]
    Knowledge of surgical options, measured using the validated 5-item knowledge sub-scale on the Decision Quality Worksheet (Sepucha et al., 2012)
  • 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 ]
    Patient-reported anxiety, measured using the validated 8-item PROMIS anxiety short form (Pilkonis et al, 2011)
  • Shared decision-making (self-reported) [ Time Frame: Immediately after the index surgical consultation visit ]
    Self-reported shared decision-making about breast cancer surgical options measured using the validated 3-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013)
  • Shared decision-making (observed) [ Time Frame: During the index surgical consultation visit ]
    Shared decision-making observed during the surgical consultation, measured using the validated observer-rated OPTION5 (Barr et al., 2015)
  • Decision regret [ Time Frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery ]
    Patient-reported feelings of decision regret, measured using the validated 5-item decision regret scale (Brehaut et al., 2003)
  • Integration of health care delivery [ Time Frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery ]
    Patient-reported measure of integration of healthcare delivery, measured using IntegRATE (Elwyn et al., 2015)
  • Financial toxicity [ Time Frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery ]
    Patient-reported measure of financial toxicity, or financial distress, as a result of their cancer diagnosis, measured by 4 items from COST (de Souza et al., 2014; de Souza et al., 2017) and self-reported out-of-pocket expenses incurred as a result of the patient's cancer diagnosis
  • Intervention's pattern of use [ Time Frame: Immediately after the index surgical consultation visit and at 1 week post surgery ]
    Determination of how the Option Grid and Picture Option Grid have been used in the surgical consultation and between the surgical consultation and surgery occurring, measured by taking pictures of the interventions immediately after the surgical consultation and asking participants to indicate how many times they (or their caregivers, family members, or relatives) have used the intervention post-surgical consultation
  • Exploration of strategies that promote the interventions' sustained use and dissemination [ Time Frame: Immediately before the index surgical consultation visit, during the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgery ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE What Matters Most: Choosing the Right Breast Cancer Surgery for You
Official Title  ICMJE Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:
Data analysts will be blinded to the clinician randomization.
Primary Purpose: Health Services Research
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Other: Option Grid
    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.
    Other Names:
    • Option Grid for Breast Cancer Surgery
    • Breast cancer: surgical options
  • Other: Picture Option Grid
    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 Name: Early-stage breast cancer: What's right for me?
Study Arms  ICMJE
  • Experimental: Arm 1: Option Grid
    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.
    Intervention: Other: Option Grid
  • Experimental: Arm 2: Picture Option Grid
    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.
    Intervention: Other: Picture Option Grid
  • No Intervention: Arm 3: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
622
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2017)
1100
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: 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.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136367
Other Study ID Numbers  ICMJE D17063
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie-Anne Durand, Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE
  • Washington University School of Medicine
  • Montefiore Medical Center
  • NYU Langone Health
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Marie-Ann Durand, MSc, PhD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP