Decision Aid for Education and Support About Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Acceptability of Decision Aid
研究概览
简要总结
The goals of this clinical trial are to evaluate DECIDES, a web-based decision support application that provides education about cancer and cancer treatment and provides support to encourage adolescent and young adult (AYA) patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.
The main questions this study aims to answer are:
- Is DECIDES acceptable, usable, and feasible for AYA, caregivers, and oncology health care providers?
- Is DECIDES helpful for AYA, caregivers, and oncology health care providers that are making cancer treatment decisions together?
AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups: (1) Usual Care, (2) DECIDES, or (3) DECIDES+. Participants in 'Usual Care' will continue to have access to their oncology health care team for questions related to cancer and cancer treatment, as per usual standard of care. Participants in both 'DECIDES' and 'DECIDES+' groups will receive access to DECIDES, and those in 'DECIDES+' will receive additional live, coach-assisted support. After 8 weeks, AYA and caregivers will complete a follow-up questionnaire and those in the 'DECIDES' and 'DECIDES+' groups will complete a semi-structured qualitative interview. Oncology clinicians of participating AYA will be invited to participate in a semi-structured qualitative interview. Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES (with an informational handout vs. coach-assisted support) report more positive decision-making processes compared to those that receive standard of care.
详细描述
DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support application that has been designed to address health literacy and includes:
- Education on cancer and cancer treatments, including clinical trials
- An exercise to identify perceived barriers and benefits to treatment options
- An exercise to clarify personal goals for treatment that align with life goals
- Resources to support communication with the oncology health care team
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
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acceptability of Decision Aid
时间窗: 8 weeks post-randomization
This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach.
Usability of Decision Aid
时间窗: 8 weeks post-randomization
This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score \>80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and \<51 reflects letter grade "F" (adjective rating "awful").
次要结局
- Knowledge of Cancer Clinical Trials(8-weeks post randomization)
- Attitudes Toward Cancer Clinical Trials(8 weeks post-randomization)
- Uncertainty in Cancer Treatment Decision-Making Process(8 weeks post-randomization)
- Perceived Involvement in Shared Treatment Decision-Making Process(8 weeks post-randomization)
- Regret About Cancer Treatment Decision-Making Process(8 weeks post-randomization)
- Self-confidence in Cancer Treatment Decision-Making Abilities(8 weeks post-randomization)
- Perceptions of Physician Engagement in Decision-Making Process(8 weeks post-randomization)
- Satisfaction With Cancer Treatment Decision-Making Process(8 weeks post-randomization)