跳至主要内容
临床试验/NCT01184066
NCT01184066已完成不适用

The ACTS Intervention to Reduce Breast Cancer Treatment Disparity

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
4
主要终点
Adherence to recommended breast cancer chemotherapy at the treatment midpoint.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

There was no masking. This intervention was open.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • African American, as determined by patient self report on their demographic form completed at first medical oncology visit
  • Age 18 or older
  • Diagnosed with invasive breast cancer
  • Recommended (prescribed) chemotherapy by participating medical oncologists

排除标准

  • Impaired cognition, as determined by a score of less than 22 on the Mini Mental Status Exam
  • An inability to understand English

研究组 & 干预措施

ACTS Intervention

Experimental

The intervention arm are the women who received the ACTS Intervention. It is a 45 minute intervention provided by a breast cancer survivor. The intervention includes a discussion of the patient's attitudes towards chemotherapy, communication strategies with providers, the recommended treatment in accordance with tumor size and tumor characteristics

干预措施: ACTS Intervention (Behavioral)

Usual Care

Active Comparator

This group receives care as usual.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Adherence to recommended breast cancer chemotherapy at the treatment midpoint.

时间窗: Midpoint of the recommented chemotherapy treatment regimen.

Midpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment midpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.

Adherence to recommended breast cancer chemotherapy at the treatment endpoint.

时间窗: Endpoint of the recommented chemotherapy treatment regimen.

Endpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment endpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.

次要结局

  • Social Support ISEL-12(baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen)
  • Symptom Incidence(baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen)
  • Symptom Distress(baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen)
  • Communication of Symptoms. The Symptom Severity and Symptoms Reporting Checklist(baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen)
  • Quality of Life-FACT Functional Assessment of Cancer Therapy(baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Quinn Rosenzweig

PhD, FNP-C, AOCNP,FAAN

University of Pittsburgh

研究点 (4)

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