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An Educational Intervention for Patients With Bladder Cancer

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ClinicalTrials.gov Identifier: NCT01915121
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Behavioral: Education Intervention Behavioral: Nutrition Intervention Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
Study Start Date : September 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Education Intervention
In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.
Behavioral: Education Intervention
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.

Placebo Comparator: Nutrition Intervention
In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
Behavioral: Nutrition Intervention
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915121


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Nihal E Mohamed, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01915121     History of Changes
Other Study ID Numbers: GCO 09-0479
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Bladder Cancer
Intervention
Education
Randomized Controlled Trials

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases