The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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