The Personal Patient Profile Decision Support for Patients With Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Program Evaluation Scale
研究概览
简要总结
There is a pressing need to develop a personalized, value-based decisional tool for bladder cancer patients undergoing radical cystectomy (bladder removal) and urinary diversion to help them with communication with the physicians, shared decision making, and preparation for disease-management and follow-up care. The proposed intervention, the Personal Patient Profile - Bladder Cancer (P3-BC), will be the first intervention to address these issues. Results of this pilot randomized feasibility study will provide evidence of the feasibility and acceptability of the P3-BC and will guide further refinement of the tool for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.
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
- •Patients: cystectomy for MIBC and NMIBC;
- •at least 18 years;
- •able to communicate in English; and
- •competent to give consent.
排除标准
- •- Existence of other cancers or ongoing cancer treatment.
研究组 & 干预措施
Usual Care
Intervention (P3-BC) Usual Care
intervention + usual care group. In addition to receiving usual care, patients will have access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.
干预措施: P3BC (Behavioral)
结局指标
主要结局
Program Evaluation Scale
时间窗: 3 month followup
Investigator-designed 12-items instrument to evaluate participants' opinions and acceptance of study procedures and their satisfaction with the decisional aid. Responses for each item range from strongly agree (1) to strongly disagree (4), with higher scores indicating greater dissatisfaction with the intervention. Full scale ranges from 12-48 with higher scores indicating greater dissatisfaction with the intervention.
Acceptability E-scale
时间窗: 3 month followup
Acceptability will be assessed with the six-item Acceptability E-scale. The acceptability is defined as 80% acceptable ratings (using mean score of more than 18 on the scale). Using well-established feasibility criteria to assess: 1) monthly screening rate, 2) monthly enrollment rate, 3) proportion of eligible patients screened who are actually recruited, 4) proportion and demographic and clinical characteristics of patients who decline to participate and reasons for refusal, 5) retention/drop-out rates, and 6) duration and completion rate of study assessments. The AES uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Full score from 0 - 30, with higher score indicating higher overall acceptability
Percent of Participants Who Agree Using the Acceptability Scale
时间窗: 1 month Follow-up
Percentage of participants who agreed with the statements taken from the Survey-based Acceptability Measure Acceptability is assessed with the 13-item web-based scale in addition to items designed by the research team for the 1-month follow-up to evaluate acceptability. The acceptability is defined as 80% acceptable ratings. Using well-established feasibility criteria to assess: 1) retention/drop-out rates, and 2) duration and completion rate of study assessments. The scale uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know.
Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale
时间窗: 1 month followup
A 1-month follow-up questionnaire included 11 additional items assessing participants' perceptions of study procedures, acceptance of the intervention, and satisfaction with the decision aid. Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know).
Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale
时间窗: 1 month follow-up
Investigator-designed 12-items instrument to evaluate intervention participants' opinions and acceptance of study procedures and their satisfaction with the decisional aid. Responses for each item range from strongly agree (1) to strongly disagree (4), with higher scores indicating greater dissatisfaction with the intervention. Original responses (1-5 visual analogue scale) were categorized as Low (scores 1-2), Neutral (score 3), or High (scores 4-5). with higher scores indicating greater dissatisfaction with the intervention.
次要结局
- The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)(3 months)
- Brief Symptom Index (BSI-18)(3 month)
- Decisional Conflict Scale(3 month)
- Bladder Cancer Knowledge Scale(3 months)
- Control Preferences Scale (CPS)(Baseline)
- Shared Decision Making Questionnaire (SDM-Q-9)(3 month)
- Self-Care Difficulty Scale(3 months)
- Shared Decision Making Questionnaire (SDM-Q-9)(1 month follow-up)
- Decisional Conflict Scale(3 months follow-up)
- Brief Symptom Index (BSI-18)(1 month follow-up and 3 month follow-up)
- Decisional Regret Scale(3 months follow-up)
- The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)(1 month follow-up)
- Bladder Cancer Knowledge Scale(3 months follow-up)
研究者
Nihal E Mohamed
Associate Professor
Icahn School of Medicine at Mount Sinai