The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01184066
First received: August 11, 2010
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: ACTS Intervention
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Adherence to recommended breast cancer chemotherapy [ Time Frame: midpoint (6 or 12 weeks) and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Support [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]
  • Symptom Incidence [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]
  • Symptom Distress [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]
  • Communication of Symptoms [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: January 2010
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACTS Intervention Behavioral: 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.
Active Comparator: Usual Care 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184066

Contacts
Contact: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP 412-383-8839 mros@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Margaret Q Rosenzweig, PhD    412-383-8839    mros@pitt.edu   
Contact: Rebecca N Dick, MS    412-648-8748    rnd4@pitt.edu   
Principal Investigator: Margaret Q Rosenzweig, PhD         
West Penn Allegheny Health System Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Stephanie Kenney, CRA    412-359-4856    SKENNEY@wpahs.org   
Principal Investigator: Jane Raymond, MD         
Principal Investigator: Helen Analo, MD         
Sponsors and Collaborators
University of Pittsburgh
West Penn Allegheny Health System
Investigators
Principal Investigator: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP University of Pittsburgh
  More Information

No publications provided

Responsible Party: Margaret Quinn Rosenzweig, University of Pittsburgh School of Nursing
ClinicalTrials.gov Identifier: NCT01184066     History of Changes
Other Study ID Numbers: 706367, RSGT-09-150-01 CPHPS
Study First Received: August 11, 2010
Last Updated: March 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Chemotherapy
Patient Adherence
African Americans
Cancer Survivor
Decision Making
Communication
Quality of Life
Social Support
Patient Education

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014