Clinical trial NCT01915121: An Educational Intervention for Patients With Bladder Cancer
Official title: An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Intervention
Education
Randomized Controlled Trials
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Decisional Regret Scale
timeFrame: Baseline
measure: Decisional Regret Scale
timeFrame: 1 month follow up
measure: Decisional Regret Scale
timeFrame: 3 month follow up
measure: Decisional Regret Scale
timeFrame: 6 month follow up
measure: Decisional Self-Efficacy Scale
timeFrame: Baseline
measure: Decisional Self-Efficacy Scale
timeFrame: 1 month follow up
measure: Decisional Self-Efficacy Scale
timeFrame: 3 month follow up
measure: Decisional Self-Efficacy Scale
timeFrame: 6 month follow up
measure: Treatment-related Values
timeFrame: Baseline
measure: Treatment-related Values
timeFrame: 1 month follow up
measure: Treatment-related Values
timeFrame: 3 month follow up
measure: Treatment-related Values
timeFrame: 6 month follow up
measure: Decisional Regret Scale
timeFrame: Baseline
measure: Decisional Regret Scale
timeFrame: 1 month follow up
measure: Decisional Regret Scale
timeFrame: 3 month follow up
measure: Decisional Regret Scale
timeFrame: 6 month follow up
Secondary outcomes:
measure: quality of life
timeFrame: Baseline
measure: quality of life
timeFrame: 1 month follow up
measure: quality of life
timeFrame: 3 month follow up
measure: quality of life
timeFrame: 6 month follow up
measure: post-surgical self-care
timeFrame: Baseline
measure: post-surgical self-care
timeFrame: 1 month follow up
measure: post-surgical self-care
timeFrame: 3 month follow up
measure: post-surgical self-care
timeFrame: 6 month follow up
measure: CES-D scale Illness Perception Questionnaire (IPQ)
timeFrame: Baseline
measure: CES-D scale Illness Perception Questionnaire (IPQ)
timeFrame: 1 month follow up
measure: CES-D scale Illness Perception Questionnaire (IPQ)
timeFrame: 3 month follow up
measure: CES-D scale Illness Perception Questionnaire (IPQ)
timeFrame: 6 month follow up
measure: Cancer worries scale
timeFrame: Baseline
measure: Cancer worries scale
timeFrame: 1 month follow up
measure: Cancer worries scale
timeFrame: 3 month follow up
measure: Cancer worries scale
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: The Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nihal E Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References: