The ACTS Intervention to Reduce Breast Cancer Treatment Disparity
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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 |
- 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 ]
- 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 |
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| Contact: Margaret Q Rosenzweig, PhD, FNP-BC, AOCNP | 412-383-8839 | mros@pitt.edu |
| 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 | |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013