An Educational Intervention for Patients With Bladder Cancer
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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The Bronx、New York、アメリカ、10468
- James J. Peters VA Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Education Intervention
In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.
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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.
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プラセボコンパレーター:Nutrition Intervention
In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Decisional Regret Scale
時間枠:Baseline
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The intervention is designed to enhance treatment decision making.
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Baseline
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Decisional Regret Scale
時間枠:1 month follow up
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The intervention is designed to enhance treatment decision making.
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1 month follow up
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Decisional Regret Scale
時間枠:3 month follow up
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The intervention is designed to enhance treatment decision making.
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3 month follow up
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Decisional Regret Scale
時間枠:6 month follow up
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The intervention is designed to enhance treatment decision making.
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6 month follow up
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Decisional Self-Efficacy Scale
時間枠:Baseline
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The intervention is designed to enhance treatment decision making.
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Baseline
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Decisional Self-Efficacy Scale
時間枠:1 month follow up
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The intervention is designed to enhance treatment decision making.
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1 month follow up
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Decisional Self-Efficacy Scale
時間枠:3 month follow up
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The intervention is designed to enhance treatment decision making.
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3 month follow up
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Decisional Self-Efficacy Scale
時間枠:6 month follow up
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The intervention is designed to enhance treatment decision making.
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6 month follow up
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Treatment-related Values
時間枠:Baseline
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The intervention is designed to enhance treatment decision making.
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Baseline
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Treatment-related Values
時間枠:1 month follow up
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The intervention is designed to enhance treatment decision making.
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1 month follow up
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Treatment-related Values
時間枠:3 month follow up
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The intervention is designed to enhance treatment decision making.
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3 month follow up
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Treatment-related Values
時間枠:6 month follow up
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The intervention is designed to enhance treatment decision making.
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6 month follow up
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Decisional Regret Scale
時間枠:Baseline
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
Baseline
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Decisional Regret Scale
時間枠:1 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
1 month follow up
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Decisional Regret Scale
時間枠:3 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
3 month follow up
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Decisional Regret Scale
時間枠:6 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
6 month follow up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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quality of life
時間枠:Baseline
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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Baseline
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quality of life
時間枠:1 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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1 month follow up
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quality of life
時間枠:3 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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3 month follow up
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quality of life
時間枠:6 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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6 month follow up
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post-surgical self-care
時間枠:Baseline
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FACT-BL Ca additional concern
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Baseline
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post-surgical self-care
時間枠:1 month follow up
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FACT-BL Ca additional concern
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1 month follow up
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post-surgical self-care
時間枠:3 month follow up
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FACT-BL Ca additional concern
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3 month follow up
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post-surgical self-care
時間枠:6 month follow up
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FACT-BL Ca additional concern
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6 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
時間枠:Baseline
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Baseline
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CES-D scale Illness Perception Questionnaire (IPQ)
時間枠:1 month follow up
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1 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
時間枠:3 month follow up
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3 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
時間枠:6 month follow up
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6 month follow up
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Cancer worries scale
時間枠:Baseline
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Baseline
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Cancer worries scale
時間枠:1 month follow up
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1 month follow up
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Cancer worries scale
時間枠:3 month follow up
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3 month follow up
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Cancer worries scale
時間枠:6 month follow up
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6 month follow up
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協力者と研究者
捜査官
- 主任研究者:Nihal E Mohamed, PhD、Icahn School of Medicine at Mount Sinai
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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