Skip to main content
OpenTrials
Completed

NCT Number: NCT01915121

An Educational Intervention for Patients With Bladder Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education Intervention

Behavioral

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.

Nutrition Intervention

Behavioral

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.

Primary outcomes

  1. Decisional Regret Scale

    Time frame: Baseline

    The intervention is designed to enhance treatment decision making.

  2. Decisional Regret Scale

    Time frame: 1 month follow up

    The intervention is designed to enhance treatment decision making.

  3. Decisional Regret Scale

    Time frame: 3 month follow up

    The intervention is designed to enhance treatment decision making.

  4. Decisional Regret Scale

    Time frame: 6 month follow up

    The intervention is designed to enhance treatment decision making.

  5. Decisional Self-Efficacy Scale

    Time frame: Baseline

    The intervention is designed to enhance treatment decision making.

  6. Decisional Self-Efficacy Scale

    Time frame: 1 month follow up

    The intervention is designed to enhance treatment decision making.

  7. Decisional Self-Efficacy Scale

    Time frame: 3 month follow up

    The intervention is designed to enhance treatment decision making.

  8. Decisional Self-Efficacy Scale

    Time frame: 6 month follow up

    The intervention is designed to enhance treatment decision making.

  9. Treatment-related Values

    Time frame: Baseline

    The intervention is designed to enhance treatment decision making.

  10. Treatment-related Values

    Time frame: 1 month follow up

    The intervention is designed to enhance treatment decision making.

  11. Treatment-related Values

    Time frame: 3 month follow up

    The intervention is designed to enhance treatment decision making.

  12. Treatment-related Values

    Time frame: 6 month follow up

    The intervention is designed to enhance treatment decision making.

  13. Decisional Regret Scale

    Time frame: Baseline

    Bladder Cancer knowledge Scale

    The intervention is designed to enhance treatment decision making.

  14. Decisional Regret Scale

    Time frame: 1 month follow up

    Bladder Cancer knowledge Scale

    The intervention is designed to enhance treatment decision making.

  15. Decisional Regret Scale

    Time frame: 3 month follow up

    Bladder Cancer knowledge Scale

    The intervention is designed to enhance treatment decision making.

  16. Decisional Regret Scale

    Time frame: 6 month follow up

    Bladder Cancer knowledge Scale

    The intervention is designed to enhance treatment decision making.

Secondary outcomes

  1. quality of life

    Time frame: Baseline

    FACT-BL, Emotional, physical, function, and social Wellbeing Subscales

  2. quality of life

    Time frame: 1 month follow up

    FACT-BL, Emotional, physical, function, and social Wellbeing Subscales

  3. quality of life

    Time frame: 3 month follow up

    FACT-BL, Emotional, physical, function, and social Wellbeing Subscales

  4. quality of life

    Time frame: 6 month follow up

    FACT-BL, Emotional, physical, function, and social Wellbeing Subscales

  5. post-surgical self-care

    Time frame: Baseline

    FACT-BL Ca additional concern

  6. post-surgical self-care

    Time frame: 1 month follow up

    FACT-BL Ca additional concern

  7. post-surgical self-care

    Time frame: 3 month follow up

    FACT-BL Ca additional concern

  8. post-surgical self-care

    Time frame: 6 month follow up

    FACT-BL Ca additional concern

  9. CES-D scale Illness Perception Questionnaire (IPQ)

    Time frame: Baseline

  10. CES-D scale Illness Perception Questionnaire (IPQ)

    Time frame: 1 month follow up

  11. CES-D scale Illness Perception Questionnaire (IPQ)

    Time frame: 3 month follow up

  12. CES-D scale Illness Perception Questionnaire (IPQ)

    Time frame: 6 month follow up

  13. Cancer worries scale

    Time frame: Baseline

  14. Cancer worries scale

    Time frame: 1 month follow up

  15. Cancer worries scale

    Time frame: 3 month follow up

  16. Cancer worries scale

    Time frame: 6 month follow up

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2013
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.