Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of participants who engage in at least 8 out of the 12 serious game sessions
研究概览
简要总结
Self-advocacy, defined as the ability of a patient to get her needs and priorities met in the face of a challenge, is an essential skill but not all women with advanced cancer are able to do it. We want to instruct women with advanced cancer who have low self-advocacy to self-advocate for their health and well-being. We will test a new "serious game" or video program that teaches self-advocacy skills through interactive, situation-based activities. The goal of the Strong Together serious game is to engage participants in challenges commonly experienced by women with advanced cancer, offer them choices to self-advocate or not, and directly show them the health and social benefits of self-advocating and the negative consequences of not self-advocating. Through engaging in the Strong Together program, participants vicariously learn the essential skills of self-advocacy, understand the downstream effects of using or not using these skills, and learn distinct behaviors that they can then use to address their own challenges.
详细描述
Background: When faced with the challenges of advanced cancer, women must advocate (or stand up) for their needs and priorities. However, there are no interventions to promote self-advocacy among female patients with advanced cancer. Preliminary work has developed a theoretically-based, psychometrically-strong measure of self-advocacy (the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale) and demonstrated correlations with symptom burden and healthcare utilization. Serious games offer a novel mechanism by which to deliver interactive, engaging health education that links users' choices to consequences so that users learn a desired skill. The fully-automated Strong Together self-advocacy serious game may allow women with advanced cancer to learn self-advocacy skills and therefore improve their health outcomes.
Objective/Hypothesis: The purpose of this pilot randomized controlled trial (RCT) is to evaluate the feasibility, acceptably, and preliminary efficacy of the Strong Together serious game.
Specific Aims:
Specific Aim 1: To evaluate the feasibility and acceptability of the 3-month Strong Together intervention.
- Benchmark 1: At least 75% of participants will engage in at least 8 out of the 12 serious game sessions.
- Benchmark 2: At least 80% of participants will find the intervention acceptable based on ratings of perceived satisfaction and ease of use, as well as feedback from qualitative exit interviews.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Stage III or IV gynecological or Stage IV breast cancer within the past 3 months being treated with non-curative intent
- •Have at least a 6-month life expectancy (as determined by their oncologist)
- •Eastern Cooperative Oncology Group performance score of 0 to 2 (per health record or oncologist)
- •Able to read and write in English
排除标准
- •On hospice at the time of recruitment
- •Impaired cognition (per health record)
- •Other active, unstable mental health disorder
结局指标
主要结局
Number of participants who engage in at least 8 out of the 12 serious game sessions
时间窗: 3 months
We will calculate the number of participants in the intervention group who complete two-thirds (66.7%) of the intervention sessions as a measure of intervention feasibility. We will accept that we achieved adequate feasibility if at least 75% of participants engage in at least eight out of the twelve serious game sessions.
Number of participants who find the intervention acceptable based on ratings of the Post Study System Usability Questionnaire and qualitative interviews.
时间窗: 3 months
We will accept that we achieved adequate acceptability if at least 80% of participants find the intervention acceptable based on the Post Study System Usability Questionnaire scores and if no issues are raised during the qualitative interviews and feedback that cannot be revised prior to the future trial.
次要结局
- Change in symptom burden as assessed by the MD Anderson Symptom Inventory scale.(Baseline, 3 months, and 6 months)
- Change in quality of life as assessed by the Functional Assessment of Cancer Therapy-General scale.(Baseline, 3 months, and 6 months)
- Change in patient self-advocacy as assessed by the Female Self-Advocacy in Cancer Survivorship Scale.(Baseline, 3 months, and 6 months)
- Change in healthcare utilization as assessed by participants' number of hospital admissions, emergency room visits, and primary care visits in the past three months.(Baseline, 3 months, and 6 months)
研究者
Teresa Thomas, PhD, RN
Assistant Professor
University of Pittsburgh