Trial record 1 of 1 for:    The ACTS Intervention to Reduce Breast Cancer Treatment Disparities
Previous Study | Return to List | Next Study

The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

This study is currently recruiting participants.
Verified March 2011 by University of Pittsburgh
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

August 11, 2010
March 8, 2011
January 2010
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01184066 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The ACTS Intervention to Reduce Breast Cancer Treatment Disparity
The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • 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.
  • Experimental: ACTS Intervention
    Intervention: Behavioral: ACTS Intervention
  • Active Comparator: Usual Care
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP 412-383-8839 mros@pitt.edu
United States
 
NCT01184066
706367, RSGT-09-150-01 CPHPS
Yes
Margaret Quinn Rosenzweig, University of Pittsburgh School of Nursing
University of Pittsburgh
West Penn Allegheny Health System
Principal Investigator: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP University of Pittsburgh
University of Pittsburgh
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP