A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRoswell Park Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Patient Navigation
BehavioralReceive patient navigation
Questionnaire
Other interventionAncillary studies
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: Health Services Research (Patient Navigation)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Enrollment rate
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.
Time frame
Up to 2 years2
Reasons for refusal
Reported reasons of refusal will be summarized using frequencies and relative frequencies
Time frame
Up to 2 years3
Retention Rate
The number of patients that complete patient navigation divided by the number of patients enrolled
Time frame
Up to 2 years4
Reasons for discontinuation
Will be summarized using frequencies and relative frequencies
Time frame
Up to 2 yearsSecondary outcomes
1
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life
Time frame
Up to 2 years2
Social Determinates of health
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.
Time frame
Up to 2 years3
Barriers to care
Patient navigators will meet with participants to discuss barriers to care. Results will be summarized
Time frame
Up to 2 years4
Use of supportive services
Will be summarized using frequencies and relative frequencies
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov