An Educational Intervention for Patients With Bladder Cancer
1 other identifier
interventional
43
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedAugust 4, 2017
August 1, 2017
3.8 years
July 30, 2013
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
6 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
Baseline
Treatment-related Values
The intervention is designed to enhance treatment decision making.
1 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
3 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
6 month follow up
Secondary Outcomes (16)
quality of life
Baseline
quality of life
1 month follow up
quality of life
3 month follow up
quality of life
6 month follow up
post-surgical self-care
Baseline
- +11 more secondary outcomes
Study Arms (2)
Education Intervention
ACTIVE COMPARATORIn this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.
Nutrition Intervention
PLACEBO COMPARATORIn this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
Interventions
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.
Eligibility Criteria
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)
- \- treatment decision is made and /beginning/completion of treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
James J. Peters VA Medical Center
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nihal E Mohamed, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 2, 2013
Study Start
September 1, 2013
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
August 4, 2017
Record last verified: 2017-08