An Educational Intervention for Patients With Bladder Cancer

Completed · Not applicable

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01915121

Run by

Icahn School of Medicine at Mount Sinai

People needed

43

Starts

2013-09-01

Expected to finish

2017-06-30

Last updated by the study team

2017-08-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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