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The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

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ClinicalTrials.gov Identifier: NCT01184066
Recruitment Status : Unknown
Verified March 2011 by University of Pittsburgh.
Recruitment status was:  Recruiting
First Posted : August 18, 2010
Last Update Posted : March 9, 2011
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by:
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: ACTS Intervention Behavioral: Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ACTS Intervention to Reduce Breast Cancer Treatment Disparity
Study Start Date : January 2010
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Adherence to recommended breast cancer chemotherapy [ Time Frame: midpoint (6 or 12 weeks) and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]

Secondary Outcome Measures :
  1. Social Support [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]
  2. Symptom Incidence [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]
  3. Symptom Distress [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]
  4. Communication of Symptoms [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]
  5. Quality of Life [ Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184066


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

Locations
United States, Pennsylvania
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         
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         
Sponsors and Collaborators
University of Pittsburgh
West Penn Allegheny Health System
Investigators
Principal Investigator: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP University of Pittsburgh

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 ( Other Grant/Funding Number: American Cancer Society )
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases