Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in Wellness
研究概览
简要总结
Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.
详细描述
Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer within last three years
- •Able to communicate in English or with the help of an interpreter.
- •Access to a device with internet connection
排除标准
- •Breast cancer patients who are considered for hospice or expected survival of less than six months.
- •Presence of active suicidal ideations.
- •Presence of active psychosis.
- •Presence of dementia
研究组 & 干预措施
Distressed
Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model.
干预措施: Standard of Care Distressed in study Arm Distressed (Behavioral)
Distressed
Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model.
干预措施: Team Based Care (Behavioral)
Non-Distressed
Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness.
干预措施: Psycho-Education (Behavioral)
Non-Distressed
Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness.
干预措施: Standard of Care Non-Distressed (Behavioral)
结局指标
主要结局
Change in Wellness
时间窗: baseline, 6 months
Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.
次要结局
- Improvement in depression compared to baseline(one year)
- Improvement in anxiety compared to baseline(One Year)
研究者
Shehzad K. Niazi
Prinicpal Investigator
Mayo Clinic