Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study

Trial Title: Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study

NCT ID: NCT05838417

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
No known BCRA 1/2 gene mutation
Mammogram
Breast Cancer Screening

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: REDS survey
Description: R - Reactance, E - self-Exemption, D - Disbelief, S - Source derogation
Arm group label: Cohort-1

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.

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Identify as female at birth

Minimum age: 39 Years

Maximum age: 49 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Colorado Hospital

Address:
City: Aurora
Zip: 80045
Country: United States

Status: Recruiting

Contact:
Last name: Tamar Parmet

Phone: 610-209-0652
Email: tamar.parmet@cuanschutz.edu

Investigator:
Last name: Laura Scherer
Email: Principal Investigator

Facility:
Name: University of Pennsylvania

Address:
City: Philadelphia
Zip: 19104
Country: United States

Status: Recruiting

Contact:
Last name: Jemimah Frempong

Investigator:
Last name: Marilyn Schapira, MD
Email: Principal Investigator

Start date: November 22, 2022

Completion date: January 2026

Lead sponsor:
Agency: University of Colorado, Denver
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Colorado, Denver

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05838417