Breast Cancer Clinical Trial
Official title:
Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
NCT number | NCT03136367 |
Other study ID # | D17063 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 18, 2017 |
Est. completion date | May 31, 2019 |
Verified date | December 2020 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 571 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
United States | Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Bellevue Hospital Center | New York | New York |
United States | NYU Langone Medical Center | New York | New York |
United States | Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Montefiore Medical Center, NYU Langone Health, Patient-Centered Outcomes Research Institute, Washington University School of Medicine |
United States,
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. — View Citation
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. Erratum in: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. eCollection 2015 Jan-Mar. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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®): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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) | 1 week post-surgery | |
Secondary | 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. | Immediately before the index surgical consultation visit and at 12 weeks post-surgery | |
Secondary | 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. | 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 | |
Secondary | 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. | Immediately after the index surgical consultation visit | |
Secondary | 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. | During the index surgical consultation visit | |
Secondary | 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. | At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery | |
Secondary | 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. | Immediately before the index surgical consultation visit and at 12 weeks post-surgery | |
Secondary | 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 | 12 weeks post-surgery (patients) or after trial participation ended (surgeons) |
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