Breast Carcinoma, Breast Ductal Carcinoma in Situ
Conditions
Brief summary
This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.
Detailed description
PRIMARY OBJECTIVE: I. Implement a patient navigation program in the Roswell Park Breast Clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (DCIS) (n=126). SECONDARY OBJECTIVE: I. Systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or DCIS to supportive services and culturally appropriate resources.
Interventions
BEHAVIORALPatient Navigation
Receive patient navigation
OTHERQuestionnaire
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years of age * Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS) * Currently identify their gender as woman or female * Was assigned female sex at birth (AFAB) \- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool * Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention
Exclusion criteria
* Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS) * Participants who have had a previous diagnosis of any cancer * Participants who were assigned male sex or intersex at birth * Unwilling or unable to follow protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Up to 2 years | Enrollment rate Will be defined as the number of patients enrolled divided by the number of patients approached. The enrollment rate will be estimated with a 90% credible region obtained by Jeffrey's prior method. |
| Reasons for refusal | Up to 2 years | Reported reasons of refusal will be summarized using frequencies and relative frequencies |
| Retention Rate | Up to 2 years | The number of patients that complete patient navigation divided by the number of patients enrolled |
| Reasons for discontinuation | Up to 2 years | Will be summarized using frequencies and relative frequencies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) | Up to 2 years | the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life |
| Social Determinates of health | Up to 2 years | An 11 question survey . A score of 11 or more when the numerical values for answers to questions 7-10 are added shows that the person might not be safe. |
| Barriers to care | Up to 2 years | Patient navigators will meet with participants to discuss barriers to care. Results will be summarized |
| Use of supportive services | Up to 2 years | Will be summarized using frequencies and relative frequencies |
| Patient Satisfaction survey | up to 2 years | Will be summarized (by time as appropriate) using frequencies and relative frequencies |
Countries
United States
Contacts
CONTACTKathryn Glaser
PRINCIPAL_INVESTIGATORKathryn Glaser
Roswell Park Comprehensive Cancer Center
Outcome results
None listed