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Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.

Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.

A newly developed 8-10 page decision aid pamphlet that discusses:1. Information on CRC; 2. Information about risk and benefits including the 10-year lag-time to benefitting from CRC screening; 3. Information to help patients evaluate CRC screening options (colonoscopy or stool testing); 4. Possible outcomes relevant to LE and health status. In addition, there will be a values clarification exercise

CRC decision aid pamphlet

The home safety information pamphlet is a 2-page fact sheet on home safety tips for older adults, and was designed by the AGS Health in Aging Foundation. It includes information in seven areas to help older adults stay safe in their homes. Areas include but are not limited to fall prevention and safety proofing homes. It has been used successfully in prior studies of DAs as a control intervention

Home Safety Pamphlet

Tamara Cadet, PhD, LICSW, MPH

Conduct a feasibility pilot RCT of a newly developed colorectal cancer screening (CRC) decision aid (DA) including 66 LHL adults 76-85 years recruited from community health centers. Hypotheses: Patients in the intervention group will be more likely to change their intentions to be screened with fewer patients with \<10 year LE and/or those with \>10 year LE and no risk factors intending to be screened and more with \>10 year LE and risk factors for CRC and/or those who have never been screened intending to be screened (primary outcome). The secondary outcomes are that the patients in the intervention group will have 1. increased knowledge of CRC screening options and the benefits and risks of these options; 2. increased SDM engagement; and 3. find the DA acceptable. Investigators also anticipate that at least 50% of eligible participants will choose to participate in the study.

Investigators will recruit and survey 66 adults (to reach a goal of 60 with complete data), 75-85 years with low health literacy LHL (30 per arm) over 24 months to learn the effects of the newly developed CRC DA pamphlet on older adult's screening intentions, knowledge of options and the benefits and harms, and SDM from community health centers. Investigators collect baseline data over the phone prior to the visit. Patients who are eligible and willing to participate will come to a regularly scheduled visit with their primary care physician (PCP) early to answer the pretest questions. Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule. The home safety information is 2 pages, and was designed by AGS Health in Aging Foundation. It has been used successfully in prior studies of DAs as a control intervention. Investigators chose this pamphlet for the control arm because it is written at \<7th grade reading level and reading about home safety should not affect screening decisions. Providing the control group the home safety pamphlet to read reduces response bias since it helps keep participants blinded to the intervention of interest and compensates for the time and attention required by the intervention group to read the DA. At the visit, participants will review the DA or the home safety pamphlet. The revised CRC DA pamphlet is expected to take 5-10 minutes to read as well as the home safety pamphlet. After completing the pre-survey questionnaire before the visit the patient will have their PCP visit. The post-test will be asked after the PCP visit in person or over the phone (depending on the participant's preference, access to a phone, and ability to stay after their appointment for enough time to complete the post-visit questionnaire). Investigators will conduct a chart review at 6 months to see if a CRC screening discussion occurred and the outcome (i.e., qualitative trends in use of CRC screening). Investigators will also call each patient at 6 months to ask about their CRC screening intentions.

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule.

Shared Decision-making and Colorectal Cancer Screening

Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy

There is not a plan to make individual participant data available to other researchers.

Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention

Number of participants who correctly answer 15 true/false knowledge questions developed the investigators, about the harms and benefits of CRC screening, Change from baseline to immediately after the intervention

Number of participants who answer the question that participants want to make a CRC screening decision with their physician, from 5 decision-making role questions developed the investigators

Number of participants who indicate the decision aid is the right length, from a likert-scale question

Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question

Number of participants who indicate the decision aid present information that is not slanted towards CRC screening or slanted away from CRC screening, from a likert-scale question

Number of participants who felt anxious after reading the decision aid, from a likert-scale question

Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question

Abramson Cancer Center at Penn Medicine

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Development and pilot testing of the decision aid (DA) has been described previously. In brief, the DA is written at a 6th grade reading level and includes information on 1) breast cancer risk factors for women \>75 years; 2) health/life expectancy; 3) likely outcomes if screened and not screened with mammography; 4) competing mortality risks; 5) breast cancer treatments; and 6) a values clarification exercise. The last page asks users their intentions of being screened on a 15-point validated scale and invites users to share this information with their clinician. PCPs whose patients are randomized to receive the DA will be sent a copy of the DA via email and a link to an optional training on using the DA (5 informational slides and a 3-minute video).

To reduce response bias and to compensate for the time and attention required by the intervention group to read the DA, patients in the control arm will be provided a two page pamphlet on home safety for older adults developed by the American Geriatrics Society (AGS) Foundation for Health in Aging. PCPs whose patients are randomized to the receive the home safety pamphlet, will be sent an email informing them that their patient will be coming in early to read health educational materials for older adults as part of a study. We otherwise do not plan any intervention for control group PCPs because we do not want to change their usual behavior. However, if PCPs in the control arm request a copy of the educational materials then we will email them a copy of the home safety pamphlet.

Mammography decision aid

Home safety pamphlet

Mara A Schonberg, MD, MPH

The aim of this study is to test whether an educational pamphlet on mammography designed for women aged 75 and older improves older women's decision-making around mammography screening. The investigators aim to show that the educational pamphlet improves older women's knowledge of the pros and cons or screening and leads to fewer women in poor health with short life expectancy being screened.

Women aged 75 and older are the fastest growing segment of the US population and breast cancer incidence increases with age. However, none of the randomized trials of mammography screening included women \>74 years and it is not known if mammography helps these women live longer. Increasingly, data suggest that women need around 10 year life expectancy to have a chance at a mortality benefit from being screened with mammography. Meanwhile, there are immediate harms to screening older women including: pain, anxiety, complications from tests after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (finding tumors that otherwise would never have caused symptoms in one's lifetime). Overdiagnosis is particularly concerning since some older women experience significant complications from breast cancer treatment. Guidelines state that there is insufficient evidence to recommend mammography screening for women aged 75 years or older and encourage clinicians to discuss the uncertainty about the balance of benefits and harms with older women. Yet, few older women are informed of potential harms of mammography before being screened, likely because explaining such uncertainty can be challenging and time consuming.

To improve older women's understanding of the benefits and risks of mammography screening, investigators previously developed and pilot tested a pamphlet decision aid (DA) on mammography screening for women aged 75+ years. The pilot pretest/posttest trial of 45 women 75+ years found that the DA resulted in older women being more knowledgeable about the benefits and risks of mammography, clearer in their values, and fewer intended to be screened, especially those with \<10 year life expectancy.

Investigators now propose a large cluster randomized controlled trial (RCT) of the DA, using primary care physician (PCP) as the unit of randomization, to definitively evaluate the DA's efficacy. The investigators aim to recruit 550 women 75-89 years from 100 PCPs who provide care at an academic primary care or geriatrics practice in Boston, three community practices in the Boston metro area, or at an academic internal medicine or family practice in North Carolina. Patient participants will either receive the DA (intervention arm) or an educational pamphlet on home safety for older adults (control arm). The investigators chose to use PCPs as the unit of randomization rather than individual patients because they anticipate that some patients will share the DA with their PCPs. Once PCPs are exposed to the DA for one patient they could change their approach to screening which could lead to contamination of the control group making it more difficult to show an effect of the DA.

Aims:

The investigators will examine and evaluate the impact of providing information on benefits and risks of mammography screening to women aged 75 and older on:

1. receipt of screening;
2. intentions of being screened;
3. knowledge of the pros and cons of being screened;
4. decisional conflict around screening;
5. preferred decision-making role around mammography (active vs. passive/shared with physician);
6. documented discussions by PCPs of the risks and benefits of mammography screening in participants' notes.

Trial of a Mammography Decision Aid for Women Aged 75 and Older

Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older

The investigators chose receipt of screening as the primary outcome since they anticipate that implementation of the DA will require that the DA impacts mammography use, especially for women with short life expectancy. The investigators will follow women for 15 months to guarantee at least two years of data since their last mammogram (the upper bound of the recommended screening interval). Research staff will review primary care notes, radiology records, and screening sheets (mammograms performed outside the medical system are manually entered on screening sheets). Research staff will contact patients or an alternate if follow-up is not complete in the medical records.

The investigators will use a validated 15-point scale to assess one's propensity to being screened. The investigators will categorize scores as 1-5 (yes), 6-10 (unsure), or 11-15 (no). The investigators will compare participants who respond with yes vs. those who are unsure or plan not to be screened.

11 questions (2 multiple choice and 9 true/false); 7 were adapted from other studies and 4 were developed based on the material in the decision aid. Correct answers will be summed.

The DCS is a validated 16 item scale to measure uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making (Cronbach's alpha=0.78 to 0.92);scores range 0-100 and lower scores indicate less conflict.

The Control Preferences Scale (CPS) is commonly used to assess patients' preferred involvement in decision-making. Research staff will categorize responses as active (patient made the final decision) versus passive too or shared with doctor.

The investigators will ask women in the intervention arm (DA group) this validated 10 item index to see if the DA prepared them to communicate with their clinician (Cronbach's alpha=0.92-0.96). For the control arm, the investigators will modify this index to ask participants how the pamphlet affects their thoughts around home safety.

The investigators will ask about length, clarity, and whether women found the materials anxiety invoking and/or whether they would recommend them to a friend. For the DA only, the investigators will ask if the material is balanced.

The investigators will examine whether the educational materials invoke anxiety using the short form of Spielberger State-Trait Anxiety Inventory.

The investigators will ask both groups their intentions to perform several home safety measures (e.g., check hot water setting) to keep participants blinded to whether they were randomized to the intervention of interest.

Research staff will review PCP notes up to 18 months after participation (in case patients choose to bring up screening at the next visit rather than the index visit) to see if PCPs documented a discussion on mammography. The investigators will categorize a woman as having received a balanced screening discussion if a note includes either: a) discussion of a limitation of screening or b) that mammography was discussed AND whether or not the patient chose to continue screening. To ensure the validity of coding of whether screening discussions occurred, at least 3 investigators will read the de-identified paragraphs of participants' records and code whether they think a balanced discussion occurred. Discrepancies will be adjudicated by consensus between investigators.

Research staff will review PCP notes up to 18 months after participation (in case patients choose to bring up screening at the next visit rather than the index visit) to see if PCPs documented a discussion on home safety (e.g., fall prevention tips). The investigators plan to assess both screening and home safety to keep chart abstractors blinded to the outcome of interest. To ensure the validity of coding of whether home safety discussions occurred, at least 3 investigators will read the de-identified paragraphs of participants' records and code whether they think a discussion occurred. Discrepancies will be adjudicated by consensus between investigators.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Shared Decision-making and Colorectal Cancer Screening	NCT04748380	Colorectal Canc...	CRC decision ai... Home Safety Pam...	75 Years - 85 Years	Abramson Cancer Center at Penn Medicine
Shared Decision-making and Colorectal Cancer Screening	NCT04748380	Colorectal Canc...	CRC decision ai... Home Safety Pam...	75 Years - 85 Years	Abramson Cancer Center at Penn Medicine
Trial of a Mammography Decision Aid for Women Aged 75 and Older	NCT02198690	Breast Cancer S...	Mammography dec... Home safety pam...	75 Years - 89 Years	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for home safety pamphlet