Clinical trial NCT05838417: Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
Official title: Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: No known BCRA 1/2 gene mutation
Mammogram
Breast Cancer Screening
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-01
Enrollment: 700
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography benefits
timeFrame: 12 months
measure: REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography harms
timeFrame: 12 months
measure: Screening intentions question
timeFrame: 12 months
measure: Number of participants who receive screening in the study period
timeFrame: 12 months
Secondary outcomes:
measure: Change in breast cancer screening knowledge from pre- to post-decision aid
timeFrame: 12 months
measure: Whether the participant had a conversation with their doctor about screening
timeFrame: 12 months
measure: Change in medical mistrust from pre- to post-decision aid
timeFrame: 12 months
measure: Perceptions of breast cancer risk
timeFrame: 12 months
measure: Emotional responses to the decision aid
timeFrame: 12 months
measure: Whether the participant plans to talk to their doctor about screening in an upcoming appointment
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Colorado, Denver
name: Laura Scherer
role: PRINCIPAL_INVESTIGATOR
References: