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The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.
This is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not started their adjuvant endocrine therapy (AET) to initiate the medication.
The research study procedures include:
This research study involves two individual sessions with a nurse practitioner, which will take place via videoconferencing, in person, or by telephone. Participants will also complete three brief questionnaire packets over the 12-week study period.
It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample with patients from racial and/or ethnic minority groups to ensure the generalizability of the study findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention | Behavioral | One-to-One virtual (videoconference) behavioral intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Program Feasibility | 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). | Up to 3 months |
| Program Acceptability | 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. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant Endocrine Therapy (AET) Initiation | Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Jacobs, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41172636 | Derived | Post KE, Dunderdale L, Datta S, Gutierrez N, Varella L, Horick N, Traeger L, Greer JA, Moy B, Temel JS, Jacobs JM. Development and refinement of a nurse-led, culturally sensitive intervention for adjuvant endocrine therapy initiation among patients with breast cancer. Eur J Oncol Nurs. 2025 Dec;79:103010. doi: 10.1016/j.ejon.2025.103010. Epub 2025 Oct 15. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2024 |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute at St Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
| Emerson Hospital/MGH Cancer Center | Concord | Massachusetts | 01742 | United States |
| Mass General at North Shore Cancer Center | Danvers | Massachusetts | 01923 | United States |
| Dana-Farber Brigham Cancer Center - Foxborough | Foxborough | Massachusetts | 02035 | United States |
| Dana-Farber Cancer Institute - Merrimack Valley | Methuen | Massachusetts | 01844 | United States |
| Dana-Farber Brigham Cancer Center at Milford Regional Medical Center | Milford | Massachusetts | 01757 | United States |
| Mass General at Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Dana-Farber Brigham Cancer Center with South Shore Hospital | Weymouth | Massachusetts | 02190 | United States |
| Dana-Farber/New Hampshire Onoclogy-Hematology | Londonderry | New Hampshire | 03053 | United States |
| COMPLETED |
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| NOT COMPLETED |
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No participants were excluded from analyses at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of participants at the time of enrollment. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex/Gender, Customized | Participants self-reported their gender at the time of enrollment. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants self-reported their race at the time of enrollment. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants self-reported their ethnicity at the time of enrollment. | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants who Initiated their Hormonal Therapy | Participants were asked to respond to this one item instrument: "At different times throughout your participation this study, you may or may not be taking/have started taking your hormonal therapy. At this time, are you currently taking your hormonal therapy (e.g., Tamoxifen, Anastrozole/Arimidex, Exemestane/Aromasin, Letrozole/Femara)?" Patients self-reported if they initiated their endocrine therapy. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Program Feasibility | 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). | 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. | Posted | Count of Participants | Participants | Up to 3 months |
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| Primary | Program Acceptability | 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. | 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. | Posted | Number | Participants | Up to 3 months |
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| Secondary | Adjuvant Endocrine Therapy (AET) Initiation | Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire. | 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. | Posted | Count of Participants | Participants | Up to 3 months |
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Adverse event data was collected from enrollment until end of follow-up, up to 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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As a single-arm pilot study, we lacked a comparator group to assess INITIATE in comparison to the standard of care or an attention-matched control. The sample size was modest, which limited our ability to evaluate clinically meaningful differences in psychosocial outcomes over the study period. Further, participants mostly had Stage 1 breast cancer, and the study was conducted at an academic medical center; thus, the findings may not be generalizable to all patients with breast cancer.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Jacobs | The Massachusetts General Hospital | 617-643-1777 | jjacobs@mgh.harvard.edu |
| Dec 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010349 | Patient Compliance |
| D000074822 | Treatment Adherence and Compliance |
| D016312 | Treatment Refusal |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000338 | beta-Aminoethyl Isothiourea |
| ID | Term |
|---|---|
| D013890 | Thiourea |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
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| Black, African American or of African background |
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| Option not listed |
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| Not reported |
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| Attendance Feasibility |
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