Trial Outcomes & Findings for Culturally Aware AET Non-Initiation Intervention (NCT NCT05465408)
NCT ID: NCT05465408
Last Updated: 2026-02-24
Results Overview
Feasibility will be demonstrated by enrollment (\>50% of eligible and approached patients will enroll), retention (\>70% of enrolled participants will complete the two intervention sessions) and attendance (≥70% of participants completing at least one session).
COMPLETED
NA
35 participants
Up to 3 months
2026-02-24
Participant Flow
From July 2022 to August 2024, study staff invited patients with early-stage, HR+ breast cancer to participate in the INITATE intervention. This study was conducted at the Massachusetts General Hospital (MGH) Cancer Center, three MGH community affiliates, and the Dana-Farber Cancer Institute. Study staff identified potentially eligible patients through EHR review from the participating site's breast oncology clinics. Study staff then approached potentially eligible patients via telephone.
Participant milestones
| Measure |
Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Experimental: Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Culturally Aware AET Non-Initiation Intervention
Baseline characteristics by cohort
| Measure |
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
n=35 Participants
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Age, Continuous
|
55.8 Years
STANDARD_DEVIATION 12.0 • n=58 Participants
|
|
Sex/Gender, Customized
Gender · Woman
|
35 Participants
n=58 Participants
|
|
Sex/Gender, Customized
Gender · Man
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Race · White or of European background
|
24 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Race · Asian, Asian American or of Asian background
|
5 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Race · Black, African American or of African background
|
4 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Race · Option not listed
|
2 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino/a/x
|
5 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino/a/x
|
29 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not reported
|
1 Participants
n=58 Participants
|
|
Number of Participants who Initiated their Hormonal Therapy
|
4 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Seventy-seven patients were eligible and approached for this study. Fourty-three of the 77 remaining patients (55.8%) consented to the study and completed the baseline measures. Six patients were lost to follow-up, and two patients withdrew their consent after completing the baseline questionnaire but before enrollment. Study staff ultimately enrolled 35 of 77 patients (45.5%) in the study. Thirty-five participants were offered the intervention.
Feasibility will be demonstrated by enrollment (\>50% of eligible and approached patients will enroll), retention (\>70% of enrolled participants will complete the two intervention sessions) and attendance (≥70% of participants completing at least one session).
Outcome measures
| Measure |
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
n=77 Participants
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Program Feasibility
Enrollment Feasibility · Feasibility
|
35 Participants
|
|
Program Feasibility
Retention Feasibility · Feasibility
|
28 Participants
|
|
Program Feasibility
Attendance Feasibility · Feasibility
|
29 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Three patients withdrew before completing all study procedures. Patient-reported reasons for study withdrawal included that they were no longer interested, felt overwhelmed by residual treatment-related side effects, and/or were busy with clinical visits. Five participants were lost to follow-up. Twenty-seven of the 35 enrolled participants completed the CSQ.
Acceptability will be demonstrated by \>75% of participants reporting average satisfaction scores greater than the mid-point of the Client Satisfaction Questionnaire. The total score range is 3-12, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
n=27 Participants
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Program Acceptability
|
25 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Three patients withdrew before completing all study procedures. Patient-reported reasons for study withdrawal included that they were no longer interested, felt overwhelmed by residual treatment-related side effects, and/or were busy with clinical visits. Five participants were lost to follow-up.
Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.
Outcome measures
| Measure |
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
n=27 Participants
Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.
|
|---|---|
|
Adjuvant Endocrine Therapy (AET) Initiation
1-Month Post-Baseline · Initiated AET
|
23 Participants
|
|
Adjuvant Endocrine Therapy (AET) Initiation
1-Month Post-Baseline · Did not initiate AET
|
4 Participants
|
|
Adjuvant Endocrine Therapy (AET) Initiation
3-Months Post-Baseline · Initiated AET
|
24 Participants
|
|
Adjuvant Endocrine Therapy (AET) Initiation
3-Months Post-Baseline · Did not initiate AET
|
3 Participants
|
Adverse Events
Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place