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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 : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Washington University School of Medicine
Montefiore Medical Center
New York University School of Medicine
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Marie-Anne Durand, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Option Grid Other: Picture Option Grid Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 622 participants
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
Official Title: Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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

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.
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?

No Intervention: Arm 3: Usual Care



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Treatment choice [ Time Frame: 1 week post-surgery ]
    Treatment choice, or which surgical or treatment option the patient chose

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136367


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Bellevue Hospital Center
New York, New York, United States, 10016
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Washington University School of Medicine
Montefiore Medical Center
New York University School of Medicine
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Marie-Ann Durand, MSc, PhD Dartmouth-Hitchcock Medical Center

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie-Anne Durand, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03136367     History of Changes
Other Study ID Numbers: D17063
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie-Anne Durand, Dartmouth-Hitchcock Medical Center:
encounter decision aids
shared decision making
socioeconomic status
disparities
decision quality

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases