Survivorship Care Planning for At Risk Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of BCS accessing a SCP from their oncology provider
研究概览
简要总结
This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet.
SECONDARY OBJECTIVES:
I. Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP.
II. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
- •Reside in Southern California
- •BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
- •BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
排除标准
- 未提供
研究组 & 干预措施
Arm I (SCP-BCS template booklet and counseling)
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
干预措施: questionnaire administration (Other)
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
干预措施: educational intervention (Other)
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
干预措施: standard follow-up care (Procedure)
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
干预措施: quality-of-life assessment (Procedure)
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
干预措施: questionnaire administration (Other)
Arm I (SCP-BCS template booklet and counseling)
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
干预措施: educational intervention (Other)
Arm I (SCP-BCS template booklet and counseling)
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
干预措施: counseling intervention (Other)
Arm I (SCP-BCS template booklet and counseling)
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Proportion of BCS accessing a SCP from their oncology provider
时间窗: At 6 months
Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).
次要结局
- Proportion of BCS accessing a SCP from their oncology provider(At 12 months)
- Adherence to SCP guidelines(At 12 months)