An Educational Intervention for Patients With Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 8/5/2017 |
| Start Date: | September 2013 |
| End Date: | June 30, 2017 |
An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
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.
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.
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, 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).
Phase 1 (Focus groups/ In-depth Interview)
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
We found this trial at
2
sites
Click here to add this to my saved trials
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials