Clinical trial NCT01184066: The Attitudes, Communication, Treatment and Support Intervention to Reduce Breast Cancer Treatment Disparity
Official title: The ACTS Intervention to Reduce Breast Cancer Treatment Disparity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Chemotherapy
Patient Adherence
African Americans
Cancer Survivor
Decision Making
Communication
Quality of Life
Social Support
Patient Education
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: West Penn Allegheny Health System
First posted: 2010-08-18
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale. The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community.

Detailed description: The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in white American women, an alarming disparity that cannot be explained by stage of disease at presentation. Nonadherence to breast cancer treatment and treatment delays from diagnosis to initiation of treatment may be among the reasons for worse breast cancer outcomes in black women. This recognition is critical because it suggests that breast cancer survival disparity can be decreased through clinical interventions that increase adherence to chemotherapy. The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale. The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community. This study is a randomized controlled trial that will test the efficacy of the ACTS Intervention vs. Usual Care on the primary outcomes of adherence to recommended breast cancer chemotherapy.

Eligibility criteria: Inclusion Criteria:

* African American, as determined by patient self report on their demographic form completed at first medical oncology visit
* Female
* Age 18 or older
* Diagnosed with invasive breast cancer
* Recommended (prescribed) chemotherapy by participating medical oncologists

Exclusion Criteria:

* Impaired cognition, as determined by a score of less than 22 on the Mini Mental Status Exam
* An inability to understand English

Primary outcomes:
measure: Adherence to recommended breast cancer chemotherapy at the treatment midpoint.
timeFrame: Midpoint of the recommented chemotherapy treatment regimen.
measure: Adherence to recommended breast cancer chemotherapy at the treatment endpoint.
timeFrame: Endpoint of the recommented chemotherapy treatment regimen.
Secondary outcomes:
measure: Social Support ISEL-12
timeFrame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
measure: Symptom Incidence
timeFrame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
measure: Symptom Distress
timeFrame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
measure: Communication of Symptoms. The Symptom Severity and Symptoms Reporting Checklist
timeFrame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
measure: Quality of Life-FACT Functional Assessment of Cancer Therapy
timeFrame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: West Penn Allegheny Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Margaret Q Rosenzweig, PhD,FNP-C
role: PRINCIPAL_INVESTIGATOR
References: