An Educational Intervention for Patients With Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      PHASE 2: Aim 2. To assess the efficacy of the ETE intervention in small RCT To achieve Aim 2
      of Phase 2, a two-group RCT (standard care (SC) plus time and attention control condition, N
      = 62 patients; SC plus ETE intervention N = 62 patients) will be conducted to examine the
      efficacy of the ETE intervention. Phase 2 will provide a) a test of the efficacy of the
      refined ETE intervention for reducing decisional conflict and regret, and improving QOL and
      post-treatment stoma and pouch care controlling for potential clinical and socio-demographic
      covariates (e.g., treatment type, age).
    

Intervention name(s): Education Intervention; Nutrition Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.; 1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bladder Cancer; Intervention; Education; Randomized Controlled Trials