Patients will receive a reminder letter signed by their family physician which indicates which cancer screening tests they are overdue for and encourages them to book an appointment for screening.

Patients will receive a phone call from a member of the practice staff. The call will inform them about which cancer screening tests they are overdue for and will encourage them to book an appointment for screening.

Letter

Phone call

Aisha Lofters, MD PhD CCFP

Tara Kiran, MD MSc CCFP

This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.

Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial

Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Randomized Clinical Trial

Unity Health Toronto

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

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

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.

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.

Picture Option Grid

Marie-Ann Durand, MSc, PhD

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.

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.

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.

Data analysts will be blinded to the clinician randomization.

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.

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

Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata

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, 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, 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).

Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery)

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.

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.

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.

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.

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.

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.

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

Washington University School of Medicine

Montefiore Medical Center

NYU Langone Health

Patient-Centered Outcomes Research Institute

Dartmouth-Hitchcock Medical Center

Principal Investigator

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.

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.

Arm 1: 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.

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.

Arm 2: Picture Option Grid

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

Arm 3: Usual Care

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

622 participants consented to take part but 6 participants withdrew consent immediately before or during baseline, leaving 616 participant with baseline information.

Marie-Anne Durand

Immediately before the index surgical consultation visit

Immediately after the index surgical consultation visit

One week post-surgery

Change in Decision Quality: Knowledge Subscale

Change in Decision Quality: Decison Process Subscale

Only participants who remained in the trial through when they had their surgery were analyzed for this outcome in order to assess the match between treatment intent and treatment received.

Change in Decision Quality: Concordance Subscale

The number of participants analyzed for treatment choice was different from other outcome measures as it is based on the number of participants for whom treatment choice data was available.

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

12 weeks post-surgery

Change in Quality of Life

immediately after the index surgical consultation visit

1 week post-surgery

Anxiety

Shared Decision-making (Self-reported)

Shared Decision-making (Observed)

1 year post-surgery

Decision Regret

Integration of Health Care Delivery

Patients

All trial surgeons

Intervention surgeons

Patients in this group received either the Option Grid or Picture Option Grid as a part of their care. Only patients in the intervention arms were interviewed for this outcome measure.

Patients in Intervention Arms

This group included all surgeons who participated in the trial. All surgeons were interviewed for this outcome measure.

Surgeons Involved in the Trial

The results are reported in two groups: patients and all surgeons. The data collection method used was semi-structured interview (using a purposive sampling technique). This was a qualitative exploration of the data. We did not interview all participants but only purposively selected 42 participants in the intervention arms. Some results in this section only apply to patients (e.g., helped with decision) and some only apply to surgeons (e.g., would recommend to other health professionals).

Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination

T1 Consultation

T2 Post-consultation

T3 1 Week After Surgery

T4 12 Weeks After Surgery

T5 1 Year After Surgery

Eligible patients will be matched to complete questionnaires in their specified preferred language. Questionnaire patient responses will also be in the patient's identified preferred language, and will be translated into English for study analysis by UHN Interpretation and Translation Services. The questionnaire will comprise of sections in multiple choice and free-text format, administered in an outpatient setting. Question domains will encompass patient demographics, comprehension of diagnosis and treatment, clinical trials, palliative care and overall experiences in the clinic from the perspective of a CALD oncology patient, including identification of any barriers to optimal care.

Interpreters will be screened by investigators and approached for their willingness to complete the questionnaires. The questionnaire will comprise of several sections in rating scale and free-text format. Questionnaires will be delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care.

Cancer Care Professionals will be screened by investigators and approached for their willingness to complete the questionnaires. The questionnaire will comprise of several sections in rating scale and free-text format. Questionnaires will be delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care.

Questionnaires will be given to patients, interpreters and cancer car professionals with aims of delineating the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies

Questionnaire

Crystal Wang

Stephanie L'Heureux

Purpose of this study to delineate the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with cultural and linguistic diversity backgrounds, in addition to highlighting any barriers to optimal patient care through questionnaires.

Approximately 45% of Toronto residents have a mother tongue other than English, and over a quarter of people speak a language other than English most often at home, with over 180 different languages and dialects spoken throughout the Greater Toronto Area. Additionally, based on the census data from 2016 there also appears to be an unbalanced distribution between minority background and socioeconomic status, with lower income neighborhoods being primarily occupied by visible minority populations, which has been associated with lower socioeconomic status and poorer health literacy, and potentially correlates with healthcare service utilization overall and worse clinical outcomes.

Although linguistically diverse patients in predominantly Caucasian societies is a common phenomenon, it is relatively poorly studied across the globe, although some reports have demonstrated a tendency towards longer inpatient lengths of stay and higher readmission rates. In particular, one retrospective cohort study at two hospital affiliated with the University of Toronto, Canada, found that in over 9000 patients who presented to the emergency room or were admitted, culturally and linguistically diverse (CALD) patients had higher rates of re-presentations and readmissions if their underlying pathology was a chronic condition (chronic airways disease or cardiac failure) due to the complex care pathways involved upon discharge. This is highly relevant to the oncology patient, as consultations are time-restricted and management algorithms are highly complex and involve multiple parallel communication pathways, which carries a higher risk of misinterpretation when coupled with a background where English is not the patient's primary spoken language.

The use of a professional interpreter in medical consultations, defined by the Ontario Council on Community Interpreting (OCCI) as a "fluently bilingual individual with appropriate training and experience who is able to interpret with consistency and accuracy and who adheres to the Standards of Practice and Ethical Principles," has been shown to reduce significantly medical communication errors as compared with ad-hoc family members, improve duration of hospitalization, reduce readmission rates and improve patient satisfaction.

Caring for patients who come from CALD backgrounds poses a unique set of challenges not only from the perspective of the patient, but also for the treating physicians and team of health professionals, including those employed by interpretation services.

The iCALD-2 protocol aims to investigate barriers affecting CALD patient care using a questionnaire approach. Collectively with the iCALD retrospective study, this protocol looks to establish a baseline from which interventional studies surrounding CALD patients and interpretive services can be launched in the future, with a view to potential expansion across other tumour site clinics .

Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies

Examining the Impact of Culturally and Linguistically Diverse Backgrounds on Patient Care and Experiences in Women With Gynecologic Malignancies (iCALD-2): A Questionnaire Study

•Eligible patients will be matched to complete questionnaires in their specified preferred language. Question domains will encompass patient demographics, comprehension of diagnosis and treatment, clinical trials, palliative care and overall experiences in the clinic from the perspective of a CALD oncology patient, including identification of any barriers to optimal care.

Questionnaires will be anonymous and delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care.

Frequencies and proportions for the answers of multiple-choice questions in Oncology clinic experiences, Clinical trials and Palliative care clinic sections of Patient Questionnaire will be calculated and reported.

Patients answer specific questions about physical, emotional and practical challenges that impact with their ability to engage in their cancer care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial	NCT02457143	Early Detection... Cancer Socioeconomic S...	Letter Phone call	21 Years - 74 Years	Unity Health Toronto
What Matters Most: Choosing the Right Breast Cancer Surgery for You	NCT03136367	Breast Cancer	Option Grid Picture Option ...	18 Years -	Dartmouth-Hitchcock Medical Center
Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies	NCT05971303	Gynecologic Can...	Questionnaire	18 Years -	University Health Network, Toronto
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial	NCT02457143	Early Detection... Cancer Socioeconomic S...	Letter Phone call	21 Years - 74 Years	Unity Health Toronto

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