Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04741503

Enrollment

1277

Registered

2021-02-05

Start date

2021-04-19

Completion date

2021-08-30

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Screening, Mammography, Oncology, Preventative Medicine

Keywords

Health Literacy, Health Disparities, Shared Decision Making

Brief summary

The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.

Interventions

OTHERBreast Cancer Screening Decision Support Tool

-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.

OTHERNational Cancer Institute Breast Cancer Screening PDQ

-Provides current information about breast cancer screening and is meant to inform and help patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

* Latina, Black, or non-Latina White women * Between the ages of 40-49 years * Can write, read, and understand English

Exclusion criteria

-Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following: * Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ\[LCIS\]) * Self-reported personal history of atypical hyperplasia * Self-reported first degree family member with history of breast cancer (e.g., mother, sister) * Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene * Self-reported prior thoracic or chest wall radiation therapy

Design outcomes

Primary

Measure	Time frame	Description
Change in Total Knowledge Score of Screening Mammography Guidelines	In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)	* The total knowledge score will be collected by the Breast Cancer and Breast Cancer Screening Mammography knowledge questions. * This questionnaire was modified from an existing breast cancer screening knowledge from Hersch et al. This questionnaire covers mammography, screening benefits and downsides, and guidelines. * Six of the knowledge questions were scored as correct (1) or incorrect/unsure (0). The percentage of correct scores was calculated per participant pre-intervention and post-intervention (range, 0-100). A higher score indicates higher knowledge.
Feelings of Being Fully Informed and Clear About the Importance of the Components for Making Informed Decisions as Measured by the Decisional Conflict Scale (DCS), Values Clarity Subscale	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-The 3-item Values Clarity Subscale (questions 4-6) uses a 5-point response format, ranging from 0 (yes) to 4 (no) to assess feelings of clarity about personal values for benefits and risks/side effects. Items are summed and scores are calculated on a range of 0 (feels extremely clear about personal values for benefits/risks) to 100 (feels extremely unclear about personal values). A higher score indicates less clarity on personal values.
Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-The 5-Point Decision Self-Efficacy Scale will be modified for breast cancer screening and will measure self-confidence or belief in one's decision-making abilities, including shared decision-making. Questions ask participants how confident they are in a variety of health related skills. This 11-item scale has five response options from not at all confident (0) to extremely confident (4). Items are summed and scores are calculated on a range of 0-100. A higher score indicates higher decisional self-efficacy.
Preparation for Decision Making Scale as Measured by PrepDM	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-The Preparation for Decision Making Scale (PrepDM) assesses a patient's perception of how useful a decision aid or educational materials are in making a screening or treatment decision. The 10-item scale uses a 5-point Likert response format, ranging from 0 (not at all) to 4 (a great deal). Items are summed and scores are calculated on a range of 0-100. Higher scores indicate higher perceived levels of preparation for decision making.

Secondary

Measure	Time frame	Description
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the usefulness of the tool for decision-making. The questionnaire asks the participant if they would find this decision tool useful when making decision for when to start screening mammography (yes, no, prefer not to answer).
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the helpfulness for decision making of the breast cancer screening decision support tool's questions. The questionnaire asks the participant if the questions in the tool made decision making easier or more difficult or if they prefer not to answer.
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures including questions eliciting ratings of the information presented in the tool. Each question will ask the participant to rate the information in the tool they viewed as poor, fair, good, or excellent to show what they thought about the way the information was presented.
Intention to Screen	In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-This is the participants' intention to undergo breast cancer screening within the upcoming year. The questionnaire asks the participant how likely they are to have a screening mammography this upcoming year. Response options include: leaning toward screening (definitely will be tested or probably will be tested), leaning away from screening (probably won't be tested or definitely won't be tested), unsure, and prefer not to answer.
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool for decision making. The questionnaire asks the participant if the tool provided enough information to help a woman decide when to start breast cancer screening mammography (yes, no, prefer not to answer).
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the length of tool. The questionnaire asks the participant to rate the length of the tool they viewed as too long, too short, just right, or prefer not to answer.
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool. The questionnaire asks the participant to rate the amount of information as too much information, too little information, just right, or prefer not to answer.
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)	-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the balance of the tool's balance. The questionnaire asks the participant to rate the tool as slanted towards screening, slanted towards NOT screening, balanced, or prefer not to answer

Countries

United States

Participant flow

Pre-assignment details

1277 participants consented to participate in the study. 767 participants were removed prior to randomization as they failed to meet screening criteria. 186 participants were removed prior to randomization as overquotas (i.e., having already met the targeted goals for race/ethnicity) were removed.

Participants by arm

Arm	Count
Breast Cancer Screening Decision Support Tool -After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.	160
Standard Breast Cancer Screening Education -After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.	164
Total	324

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Initial Enrollment	Failed to meet screening criteria	0	0	767
Initial Enrollment	Overquotas removed	0	0	186
Met Protocol Criteria for Data Inclusion	Removed from study for not meeting protocol criteria for free responses to knowledge questions	23	17	0

Baseline characteristics

Characteristic	Breast Cancer Screening Decision Support Tool	Standard Breast Cancer Screening Education	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	160 Participants	164 Participants	324 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants	52 Participants	98 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants	111 Participants	225 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	1 Participants	5 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Black or African American	51 Participants	61 Participants	112 Participants
Race (NIH/OMB) More than one race	13 Participants	12 Participants	25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants	17 Participants	27 Participants
Race (NIH/OMB) White	81 Participants	72 Participants	153 Participants
Region of Enrollment United States	160 participants	164 participants	324 participants
Sex: Female, Male Female	160 Participants	164 Participants	324 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 137	0 / 147
other Total, other adverse events	0 / 137	0 / 147
serious Total, serious adverse events	0 / 137	0 / 147

Outcome results

Primary

Change in Total Knowledge Score of Screening Mammography Guidelines

* The total knowledge score will be collected by the Breast Cancer and Breast Cancer Screening Mammography knowledge questions. * This questionnaire was modified from an existing breast cancer screening knowledge from Hersch et al. This questionnaire covers mammography, screening benefits and downsides, and guidelines. * Six of the knowledge questions were scored as correct (1) or incorrect/unsure (0). The percentage of correct scores was calculated per participant pre-intervention and post-intervention (range, 0-100). A higher score indicates higher knowledge.

Time frame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)

Arm	Measure	Group	Value (MEAN)	Dispersion
Breast Cancer Screening Decision Support Tool	Change in Total Knowledge Score of Screening Mammography Guidelines	Pre-questionnaire	51.0 score on a scale	Standard Deviation 26.1
Breast Cancer Screening Decision Support Tool	Change in Total Knowledge Score of Screening Mammography Guidelines	Post-questionnaire	56.2 score on a scale	Standard Deviation 28.6
Standard Breast Cancer Screening Education	Change in Total Knowledge Score of Screening Mammography Guidelines	Post-questionnaire	54.6 score on a scale	Standard Deviation 29.3
Standard Breast Cancer Screening Education	Change in Total Knowledge Score of Screening Mammography Guidelines	Pre-questionnaire	47.0 score on a scale	Standard Deviation 26.4

Primary

Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale

-The 5-Point Decision Self-Efficacy Scale will be modified for breast cancer screening and will measure self-confidence or belief in one's decision-making abilities, including shared decision-making. Questions ask participants how confident they are in a variety of health related skills. This 11-item scale has five response options from not at all confident (0) to extremely confident (4). Items are summed and scores are calculated on a range of 0-100. A higher score indicates higher decisional self-efficacy.