Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Measurement of the change in Hope Enhancement
研究概览
简要总结
The study will access whether breast cancer patients and oncologists can become more hopeful after participating in a "hope enhancement workshop." Several validated tools, Adult Hope Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI)" and other quality of life parameter surveys, will be administered at specified intervals.
详细描述
The aim of the proposed research is to study the impact of hope interventions on the coping behavior of women with advanced breast cancer and physicians who provide care to patients with cancer.
It is the investigator's contention, that improved hopefulness among cancer patients can be manifest in improved Quality of Life (QOL). The challenge is to find specific interventions that can optimize hopefulness and thereby direct individuals to adopt behavior styles that contribute to a positive effect on QOL.
Two separate single-day interventions and hope applications will be developed for patients and oncologists, respectively. What will be common for each workshop is that there will be an experienced counselor designated as "coordinator" who will be in charge of implementing the program and monitoring group dynamics. The interventions will be structured with the program advancing from the identification of goals to the development of directions reasonable pathways for achieving the delineated goals. In addition to goal-directed exercises, the workshop will employ narrative techniques which utilize literary triggers as a springboard for reflective writing.
The smartphone-based application will prompt study participants on a daily basis to engage in additional, short activities designed to augment hopefulness, assess progress in achieving goals, and identifying challenges. In addition, the application will allow sustained interaction of workshop participants through social media exchange.
Course materials will be sent to study participants one week prior to the conduct of the workshop.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Inclusion Criteria (patient component of study)
- •Diagnosis of invasive breast cancer that is Stage IV.
- •Female, 18 years of age or older.
- •Able to proficiently speak, read, write English.
- •ECOG performance status between 0 and
- •Subjects must have a smartphone with at least "3rd generation" mobile technology, and willingness to download and utilize specialized application
- •Expected to continue cancer care at the institution where cancer was begun for the duration of the study.
- •Inclusion Criteria (physician component of study)
- •Board certification or board eligibility in any of the 3 oncologic disciplines:
- •Medical Oncology
- •Surgical Oncology
- •Radiation Oncology
- •Able to proficiently speak, read, write English.
- •Subjects must have a smartphone with at least "3rd generation" mobile technology, and willingness to download and utilize specialized application
- •NB: There will not be active recruitment of physicians who are subordinate to the respective investigators. In the event that such a physician desires to enroll on the study, formal application will be made to the institutional ethics committees to verify that coercion has not taken place.
排除标准
- •Exclusion Criteria (applies to both patients and physicians)
- •Participant actively undergoing psychotherapy for depression.
- •Documented history of Alzheimer's disease or other forms of dementia.
- •Participants practicing mindfulness meditation for an average of more than 1 hour/week.
研究组 & 干预措施
Breast Cancer patient
Patients with Stage IV breast cancer will be taught to build hope by defining attainable goals for themselves in a Hope Enhancement Workshop.
干预措施: Hope Enhancement Workshop (Behavioral)
Oncologists
Oncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop.
干预措施: Hope Enhancement Workshop (Behavioral)
结局指标
主要结局
Measurement of the change in Hope Enhancement
时间窗: The primary measurement will be carried out prior to and 3 months following the workshop
Enhancement of hopefulness as measured by Adult Hope Scale
Measurement of the change in Hopefulness
时间窗: The primary measurement will be carried out prior to and 3 months following the workshop
Enhancement of hopefulness as measured by Herth Hope Index.
Measurement of the change in Quality of Life and Emotional Stress Anxiety
时间窗: The primary measurement will be carried out prior to and 3 months following the workshop
The study will measure QOL and emotional stress anxiety prior to and 3 months following the intervention. Towards these ends, we will use the Patient-Reported Outcomes Measurement Information System (PROMIS) scale (10-point version).
Measurement of the change in Quality of Life and Well Being
时间窗: The primary measurement will be carried out prior to and 3 months following the workshop
The study will measure QOL and well-being prior to and 3 months following the intervention. Towards these ends, we will use the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) scale.
次要结局
- Measurement of the change in burnout among oncologists(The measurement will be carried out prior to and 3 months following the workshop.)