跳至主要内容
临床试验/NCT01915121
NCT01915121已完成不适用

An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society

Icahn School of Medicine at Mount Sinai3 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
3
主要终点
Decisional Self-Efficacy Scale

研究概览

简要总结

The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer.

Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.

详细描述

The goals of the study are: 1) to further enhance the design and application of the ETE intervention, and 2) to provide data on the efficacy of the refined ETE intervention in a randomized-controlled study (RCT). To achieve these 2 goals, the study is divided in to 2 phases.

PHASE 1: To enhance and refine the design and application of the preliminary ETE intervention:

Aim 1-a: To explore knowledge, beliefs, values and expectations about treatment options, treatment decision making, and quality of life (QOL) among patients with BL Ca.

To achieve Aim 1-a of Phase 1, as a first step, 2 focus groups (FG; N = 10 each) of invasive BL Ca patients will be conducted to a) examine knowledge, beliefs, values, expectations, and affective responses about treatment options and treatment decision making, b) record difficulties and problems in post-surgical health care (e.g., using stoma appliances and catheters), and c) explore concerns patients have as they live with the impact of treatment. The ETE intervention will be refined based on FG results.

Aim 1-b: To explore patients' acceptability of the refined ETE intervention. To achieve Aim 1-b of Phase 1, additional 2 FG (FG; N = 10 each) of BL Ca survivors will be conducted to solicit input about the design and acceptability of the refined ETE intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • treatment of invasive Bladder Cancer a with cystectomy and one of the three major urinary diversion methods
  • English speaking
  • between the ages of 18 and 85
  • able and willing to provide informed consent
  • may have received neoadjuvant or adjuvant chemotherapy, radiation therapy, and immunotherapy (BCG)

排除标准

  • metastatic disease or cancer recurrence
  • presence of other primary cancers
  • no access to a telephone
  • Phase 2 (randomized-controlled-study)
  • Additional Exclusion Criteria:
  • treatment decision is made and /beginning/completion of treatment.

研究组 & 干预措施

Education Intervention

Active Comparator

In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.

干预措施: Education Intervention (Behavioral)

Nutrition Intervention

Placebo Comparator

In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery

干预措施: Nutrition Intervention (Behavioral)

结局指标

主要结局

Decisional Self-Efficacy Scale

时间窗: 6 month follow up

The intervention is designed to enhance treatment decision making.

Treatment-related Values

时间窗: 6 month follow up

The intervention is designed to enhance treatment decision making.

Decisional Regret Scale

时间窗: 6 month follow up

The intervention is designed to enhance treatment decision making.

次要结局

  • post-surgical self-care(6 month follow up)
  • CES-D scale Illness Perception Questionnaire (IPQ)(6 month follow up)
  • Cancer worries scale(6 month follow up)
  • quality of life(6 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验