Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change from preoperative in VAS General Anxiety at post-operative
研究概览
简要总结
This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.
详细描述
The main research questions focus on whether the toolkit provides short-term benefits on symptoms associated with surgery (i.e., pain, anxiety, nausea) and whether it impacts emotional distress and other symptoms (i.e., pain, fatigue, sleep disturbance, global health, quality of life) at a two-week post-operative time point. This study will be conducted at San Antonio Military Medical Center (SAMMC) in active duty, veteran, and military dependent women newly diagnosed with breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option. One to two weeks prior to surgery, women diagnosed with breast cancer at SAMMC Oncology Department will be invited to participate in this study. Those who meet criteria and agree to participate will be enrolled on-study and randomly assigned to either the surgical toolkit group or standard care group. During the pre-operative period, women in the intervention group will be asked to read through the manual, listen to each of the 8 audiofiles at least once but as many times as desired, and to wear the acupressure wristbands during surgery. Women randomized to the standard care group will not receive an intervention prior to surgery but will receive the toolkit at study completion. The rationale for providing women in the standard care group with the toolkit at their post-operative visit is that the skills of breathing, meditation, and guided imagery might be potentially beneficial for them to use during their subsequent treatment or a future surgery. Additionally, qualitative interviews will be conducted in a cohort of women from the intervention group, at a two-week post-operative time point to assess their impressions and satisfaction with the toolkit; questions will focus on whether the individual used each of the toolkit's components, frequency of use, how she would rate the product's attributes (e.g., ease of use, clarity of instructions, quality rating, helpfulness), and perceptions about the helpfulness and usefulness of learned mind-body skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •18+ years of age
- •Women treated at SAMMC Oncology clinic or CRDAMC Oncology clinic for newly-diagnosed breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option
排除标准
- •Women receiving chemotherapy, radiation or hormone therapy as first line treatment for breast cancer (i.e., any of these treatment options prior to surgery)
- •Severe hearing-impairment (i.e., that would interfere with ability to hear the toolkit audiofiles)
结局指标
主要结局
Change from preoperative in VAS General Anxiety at post-operative
时间窗: Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Anxiety is rated by the patient on a scale of 0 to 10, 0 being "not at all anxious" and 10 being "extremely anxious." This instrument will take up to 1 minute to complete.
次要结局
- Change from pre-operative DVPRS at post-operative(Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery))
- Change from preoperative VAS Nausea at post- operative(Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery))
- Change from baseline (PROMIS-57) Fatigue to pre-operative and follow-up 2 weeks post-operative(Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative)
- Change from baseline (PROMIS-57) Sleep Disturbance to pre-operative and follow-up 2 weeks post-operative(Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative)
