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Culturally Aware AET Non-Initiation Intervention

Primary Purpose

Breast Cancer, Survivorship, Treatment Compliance

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
Age 21 or older
Diagnosis of early-stage (Stage 0-IIIB), hormone receptor-positive breast cancer
Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future and reports hesitations to start AET as determined by a score of >/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)"
Ability to read and respond in English or Spanish
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report

Exclusion Criteria:

Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
Cognitive impairment that prohibits participation in the study
Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
Participating in a clinical trial involving AET

Sites / Locations

Massachusetts General Hospital Cancer Center
Emerson Hospital/MGH Cancer Center
Mass General at North Shore Cancer Center
Mass General at Newton Wellesley Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05465408

First Posted

July 15, 2022

Last Updated

July 25, 2022

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05465408

Brief Title

Culturally Aware AET Non-Initiation Intervention

Official Title

Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2022 (Anticipated)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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 begun taking adjuvant endocrine therapy (AET) to initiate the medication. The research study procedures include: screening for eligibility two individual study intervention sessions study assessment follow-up questionnaires This research study involves two individual sessions with a nurse practitioner which will take place via videoconferencing sessions either in-person or via telephone. Participants will also complete three brief questionnaire packets over the 12-week course of the study. It is expected that about 30 people will take part in this research study. The investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Survivorship, Treatment Compliance, Treatment Adherence, Treatment Refusal

Keywords

Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Intervention Description

One-to-One virtual (videoconference) behavioral intervention.

Primary Outcome Measure Information:

Title

Program Feasibility

Description

Time Frame

Up to 3 months/12 weeks

Title

Program Acceptability

Description

Time Frame

Up to 3 months/12 weeks

Secondary Outcome Measure Information:

Title

Adjuvant endocrine therapy (AET) Initiation

Description

Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.

Time Frame

Baseline (within 1-week of consent), 1-month, and 3-months post-baseline

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Age 21 or older Diagnosis of early-stage (Stage 0-IIIB), hormone receptor-positive breast cancer Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future and reports hesitations to start AET as determined by a score of >/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)" Ability to read and respond in English or Spanish Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report Exclusion Criteria: Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year Cognitive impairment that prohibits participation in the study Undergoing primary treatment for other cancer (i.e., advanced stage cancer) Participating in a clinical trial involving AET

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jamie M Jacobs, PhD

Phone

617-643-1777

jjacobs@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

Facility Name

Emerson Hospital/MGH Cancer Center

City

Concord

State/Province

Massachusetts

ZIP/Postal Code

01742

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

Facility Name

Mass General at North Shore Cancer Center

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

Facility Name

Mass General at Newton Wellesley Hospital

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02462

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, Phd

First Name & Middle Initial & Last Name & Degree

Jamie M Jacobs, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Culturally Aware AET Non-Initiation Intervention

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