Teleconference Group: Breast Cancer in African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Social connection
研究概览
简要总结
African American women with breast cancer have decreased quality of life (and mood when compared to European American. Research has not examined the effectiveness of therapeutic group for African American women with breast cancer even though positive effects are well established for Caucasians. The aims of the randomized clinical trial are to determine the effectiveness of TG by teleconference for African American women with breast cancer and what factors may impact on the intervention. The primary hypothesis is that participants in the intervention group will have significantly greater cancer knowledge, less fear, less isolation, better social connection, better mood, and better QOL when compared to a control group receiving usual psychosocial care. Two hundred forty African American women with breast cancer will be recruited. Intervention participants attend eight weekly 90 minute sessions by teleconference and two follow-up boosters. Each culturally appropriate session contains the story, information and group processes of connection, commonality and catharsis. Information focuses on increasing self care and stress management knowledge while countering myths and taboos. Story capitalizes on African American oral traditions by discussing coping parables. Group processes provide an alternative source of social support and opportunities to express feelings. Control group subjects receive standard psychosocial care (the use of any support programs or services locally or nationally. Testing will occur at baseline, after 10 group sessions and 16 weeks post baseline. The study findings are expected to inform about the effectiveness of therapeutic groups in African American women with breast cancer and lay the groundwork for exploring if reducing disparities in psychosocial care have a health benefit.
详细描述
A. Specific Aims Aim One The major aim of the proposed study is to compare the effects of a TG by conference call for AAWBC with usual psychosocial care. We hypothesize that AAWBC who receive the TG by teleconference will have significantly greater cancer knowledge, less fear, less isolation, better social connection, better mood, and better QOL than a control group receiving usual psychosocial care.
Aim One A: Substantiate intervention integrity (purity, dosage, specificity and interventionist competency) of first 14 waves of study.
Aim One B: Establish reliability and validity of measures (Profile of Mood States and Functional Assessment of Cancer Therapy - Breast Cancer Version, Social Support Questionnaire) Aim Two To have a strong intervention, it is essential to identify the processes of change that lead to beneficial outcomes.29, 30 Therefore, the second aim of the proposed study is to identify the mediators of the intervention that predict successful treatment outcomes.
Aim Three Since it is particularly important to identify AA women's characteristics and sociocultural factors which may affect their responses to the intervention,30, 31 the third aim of the study is to identify the effects of demographic, health and socio-cultural variables as moderators of treatment effects on social connection, and QOL.
Aim Three A: Examine baseline moderators and concept of social connection to establish associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American women
- •age 21 or older
- •diagnosed with invasive/infiltrating ductal carcinoma
- •reside in South Carolina or the borders of North Carolina or Georgia
排除标准
- •Non-english speaking
- •diagnosed with metastatic disease at diagnosis
- •have a major cognitive impairment
- •have a current diagnosis of psychosis
- •are undergoing concurrent treatment for another form of cancer (except basal cell or squamous cell of skin)
- •Participation in another behavioral trial
研究组 & 干预措施
Usual Psychosocial Care
Participants are free to use any psychosocial care available to cancer patients. No restrictions to participation in other groups or services.
Therapeutic Group by teleconference
ten 90 minute group sessions by teleconference. Lead by social workers. Sessions focus on information, story sharing and coping.
干预措施: Therapeutic Group by Teleconference (Behavioral)
结局指标
主要结局
Social connection
时间窗: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks
Measured using the social well-being scale from the FACT-B
次要结局
- Fatalism(Participants are assessed at time one (baseline/pretest) and followed for 16 weeks)
研究者
Sue Heiney
Research Professor
University of South Carolina
