The Attitudes, Communication, Treatment and Support Intervention to Reduce Breast Cancer Treatment Disparity

NCT ID: NCT01184066

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACTS Intervention

The intervention arm are the women who received the ACTS Intervention. It is a 45 minute intervention provided by a breast cancer survivor. The intervention includes a discussion of the patient's attitudes towards chemotherapy, communication strategies with providers, the recommended treatment in accordance with tumor size and tumor characteristics

Group Type: EXPERIMENTAL

ACTS Intervention

Intervention Type: BEHAVIORAL

ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime intensive 45 minute intervention delivered by a black breast cancer survivor and utilizing video, graphics, teaching tools, and supportive testimony to encourage chemotherapy adherence.

Usual Care

This group receives care as usual.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual Care will consist of standard therapy education by a registered nurse in the treatment center. Education and support from clinicians are offered as needed throughout the course of cancer treatment at all participating medical oncology clinics.

Interventions

ACTS Intervention

ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime intensive 45 minute intervention delivered by a black breast cancer survivor and utilizing video, graphics, teaching tools, and supportive testimony to encourage chemotherapy adherence.

Intervention Type: BEHAVIORAL

Usual Care

Usual Care will consist of standard therapy education by a registered nurse in the treatment center. Education and support from clinicians are offered as needed throughout the course of cancer treatment at all participating medical oncology clinics.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West Penn Allegheny Health System

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Margaret Quinn Rosenzweig

PhD, FNP-C, AOCNP,FAAN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Q Rosenzweig, PhD,FNP-C

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

RSGT-09-150-01 CPHPS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

706367

Identifier Type: -

Identifier Source: org_study_id