Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01915121
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2013-07-30
Brief Title:
An Educational Intervention for Patients With Bladder Cancer
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 eg 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
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 ie 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 eg 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 eg 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 eg treatment type age
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 eg 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 eg treatment type age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None