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

NCT01184066 | Completed DMC

• 2 other identifiers: 706367RSGT-09-150-01 CPHPS
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Chemotherapy; Patient Adherence; African Americans; Cancer Survivor; Decision Making; Communication; Quality of Life; Social Support; Patient Education

Outcome Measures

Primary Outcomes (2)

• Adherence to recommended breast cancer chemotherapy at the treatment midpoint.

  Midpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment midpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.

  Midpoint of the recommented chemotherapy treatment regimen.

• Adherence to recommended breast cancer chemotherapy at the treatment endpoint.

  Endpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment endpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.

  Endpoint of the recommented chemotherapy treatment regimen.

Secondary Outcomes (5)

• Social Support ISEL-12

  baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

• Symptom Incidence

  baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

• Symptom Distress

  baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

• Communication of Symptoms. The Symptom Severity and Symptoms Reporting Checklist

  baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

• Quality of Life-FACT Functional Assessment of Cancer Therapy

  baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

Study Arms (2)

ACTS Intervention

EXPERIMENTAL

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

Behavioral: ACTS Intervention

Usual Care

ACTIVE COMPARATOR

This group receives care as usual.

Behavioral: Usual Care

Interventions

ACTS Intervention 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.

ACTS Intervention

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• West Penn Allegheny Health System: collaborator

Study Sites (2)

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance; Communication

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Margaret Q Rosenzweig, PhD,FNP-C

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There was no masking. This intervention was open.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, FNP-C, AOCNP,FAAN

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 18, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)