Breast Cancer, Survivorship, Treatment Adherence, Treatment Compliance, Treatment Refusal
Conditions
Keywords
Breast Cancer, Survivors, Hormone Therapy, Treatment Refusal, Treatment Compliance, Treatment Adherence
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 started their 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, 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.
Interventions
BEHAVIORALCulturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention
One-to-One virtual (videoconference) behavioral intervention.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Age 21 or older * Diagnosis of early-stage (Stage I-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 another cancer (i.e., advanced-stage cancer) * Participating in a clinical trial involving AET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Feasibility | Up to 3 months | 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 | Up to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Adjuvant Endocrine Therapy (AET) Initiation | Up to 3 months | Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJamie M Jacobs, PhD
Massachusetts General Hospital
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.8 Years STANDARD_DEVIATION 12 |
| Number of Participants who Initiated their Hormonal Therapy | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino/a/x | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino/a/x | 29 Participants |
| Race/Ethnicity, Customized Ethnicity Not reported | 1 Participants |
| Race/Ethnicity, Customized Race Asian, Asian American or of Asian background | 5 Participants |
| Race/Ethnicity, Customized Race Black, African American or of African background | 4 Participants |
| Race/Ethnicity, Customized Race Option not listed | 2 Participants |
| Race/Ethnicity, Customized Race White or of European background | 24 Participants |
| Sex/Gender, Customized Gender Man | 0 Participants |
| Sex/Gender, Customized Gender Woman | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
None listed