Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 2
- 主要终点
- REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography harms
研究概览
简要总结
All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates.
详细描述
All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will also be asked to report on whether they talked about mammography screening and the content of the DA with their provider. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates. Time 1 will be an online survey that addresses Aim 1, assessing participants' evaluations of mammography evidence conveyed in the DA. Time 2 will include repeated measures from Time 1 and additionally assess the following: 1. Whether screening was discussed with the provider. 2. If screening was not discussed, why not (e.g. did not want to, no time, other pressing issues, etc.). 3. If screening was discussed, (a) what content from the DA was discussed (i.e. benefits, false positives, overdiagnosis), (b) overall satisfaction with the discussion, (c) whether the provider offered a screening recommendation, (d) open-ended qualitative response eliciting how the discussion went. 4. Whether discussed the BCS-DA with anyone else (e.g., friends or family). 5. Patient activation. 6. Preferred role in decision-making. 7. Perceived barriers to screening. Finally, participants' information environment will be assessed using questions from Pearlman et al. (1997), 8. information seeking (e.g. to what extent the participant valued opinions from the provider, friends, and family), 9. information sharing and communication (e.g. screening attitudes of friends and family), and 10. perception of self as disseminator of mammography-related information. Time 3 will repeat the summary of mammography evidence and measures from Time 2. At Time 4 the team will assess whether screening was received up to one year after study enrollment using the participants' self reports and electronic medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 39 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who identify as female at birth
- •Ages 39-49 years old (inclusive) at the time of consent
- •English literacy
- •Internet access
- •No prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ
- •No known BCRA1/2 gene mutation
排除标准
- •Individuals who identify other than female at birth
- •Individuals who are currently pregnant
- •Individuals < 39 years old or 50 years old and > at the time of consent
- •Lack English literacy
- •Lack of internet access
- •Prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ
- •Known BCRA1/2 gene mutation
- •Decisionally Challenged Individuals
- •Prisoners or those on alternative sentencing or probation
研究组 & 干预措施
Cohort-1
Individuals who identify as female at birth age 39-49 without a prior breast cancer diagnosis (including DCIS or LCIS) or known BCRA1/2 gene mutations.
干预措施: REDS survey (Behavioral)
结局指标
主要结局
REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography harms
时间窗: 12 months
Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography harms (over diagnosis and false positive results). This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1. Reactions to over diagnosis and false positives will be assessed separately.
Screening intentions question
时间窗: 12 months
This is a single item question in which participants will indicated their intentions to initiate regular screening with mammograms, using a 4 category response: 1. screen now, 2. wait until they are older but before age 50, 3. wait until age 50, or 4. do not intend to screen in the future at any age
Number of participants who receive screening in the study period
时间窗: 12 months
We will use medical records to identify whether the participant has received screening in the 12-month study period
REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography benefits
时间窗: 12 months
Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography benefits. This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1.
Number of Participants Who Receive Screening in the Study Period
时间窗: 12 months
We will use medical records to identify whether the participant has received screening in the 12-month study period
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
时间窗: 12 months
Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography benefits. This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1. Higher scores indicate more reactance, self-exemption and disbelief.
Screening Intentions Question
时间窗: 12 months
This is a single item question in which participants will indicated their intentions to initiate regular screening with mammograms, using a 4 category response: 1. screen now, 2. wait until they are older but before age 50, 3. wait until age 50, or 4. do not intend to screen in the future at any age
次要结局
- Change in breast cancer screening knowledge from pre- to post-decision aid(12 months)
- Whether the participant had a conversation with their doctor about screening(12 months)
- Change in medical mistrust from pre- to post-decision aid(12 months)
- Perceptions of breast cancer risk(12 months)
- Emotional responses to the decision aid(12 months)
- Whether the participant plans to talk to their doctor about screening in an upcoming appointment(12 months)