Home-Based Supportive Care Program for NMIBC Patients Receiving Intravesical Perfusion: Construction and Preliminary Application (NMIBC-HSC)
Construction and Preliminary Application of Home-Based Supportive Care Program for Patients With Non-Muscle Invasive Bladder Cancer Undergoing Intravesical Perfusion Therapy
調査の概要
状態
詳細な説明
（1)Identification of Supportive Care Needs for Patients Receiving Postoperative Intravesical Chemotherapy for Non-Muscle-Invasive Bladder Cancer (Qualitative Study): Employing a descriptive qualitative research approach based on the Supportive Care Needs Framework, semi-structured in-depth interviews were conducted with patients undergoing postoperative intravesical chemotherapy for non-muscle-invasive bladder cancer (NMIBC). This systematically explored the authentic care needs of patients across multiple dimensions including physiological, psychological, social, emotional, spiritual, informational, and practical aspects, providing precise evidence for subsequent scheme development.
(2) Summary of Best Evidence for Supportive Care of NMIBC Patients Undergoing Postoperative Intravesical Chemotherapy (Evidence-Based Research): Centered on the core needs identified through qualitative research, an evidence-based nursing research methodology was utilized. Systematic retrieval of domestic and international databases, guideline websites, and evidence-based resource libraries was performed. The retrieved clinical guidelines, expert consensus statements, systematic reviews, randomized controlled trials, and quasi-experimental studies underwent rigorous quality assessment and evidence extraction to formulate a comprehensive summary of best supportive care evidence for this population.
(3) Development of a Supportive Care Scheme for NMIBC Patients Undergoing Postoperative Intravesical Chemotherapy (Delphi Method): Integrating patient needs derived from qualitative research with best evidence from evidence-based research, a draft supportive care scheme was formulated. The Delphi expert consultation method was employed, inviting experts from urology medicine, nursing, and rehabilitation fields to participate in two rounds of consultations. Through calculation of expert positive coefficient, authority coefficient, and Kendall's harmony coefficient, items were screened and revised, ultimately constructing a scientific, systematic, and operable supportive care scheme.
(4) Evaluation of the Feasibility of the Supportive Care Scheme: Following scheme formulation, feasibility evaluation was conducted using NMIBC patients receiving postoperative intravesical chemotherapy attending the outpatient department of a tertiary hospital in Nanjing. Participants were divided into an intervention group (receiving the newly developed supportive care scheme) and a control group (receiving routine outpatient care). During the study, patient recruitment and retention rates, intervention implementation processes, and compliance were observed and recorded. Post-intervention, acceptability of the scheme and perceived implementation burden by both patients and staff were collected to evaluate its feasibility in clinical practice.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chunhua Zheng, Bachelor
- 電話番号：+8613584042177
- メール：303618002@qq.com
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210001
- Nanjing First Hospital
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Patients pathologically diagnosed with NMIBC, who have undergone TURBT and are receiving intravesical perfusion therapy; Aged 18 years old or above; Clear consciousness with basic literacy and communication skills; Expected survival time ≥ 6 months; Voluntary participation with signed informed consent.
Exclusion Criteria:
Patients complicated with severe cardiovascular and cerebrovascular diseases, hepatic or renal dysfunction, or mental disorders; Patients combined with other malignant tumors; Patients with a history of severe allergic reactions or contraindications to intravesical perfusion therapy.
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：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Supportive care program
Establishing a Dedicated Nursing Team: The team consists of one urology specialty nurse (team leader), one attending physician, one rehabilitation therapist, one dietitian, one psychological counselor, and the researchers of this study.
All members received uniform protocol training prior to intervention to ensure homogeneity in intervention delivery.
This comprehensive supportive care program is implemented for patients undergoing post-operative intravesical therapy for non-muscle-invasive bladder cancer, encompassing physiological/practical support, informational support, psychological/emotional support, and social/spiritual support, with the aim of enhancing treatment adherence and quality of life.
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Establishing a Dedicated Nursing Team: The team consists of one urology specialty nurse (team leader), one attending physician, one rehabilitation therapist, one dietitian, one psychological counselor, and the researchers of this study.
All members received uniform protocol training prior to intervention to ensure homogeneity in intervention delivery.
This comprehensive supportive care program is implemented for patients undergoing post-operative intravesical therapy for non-muscle-invasive bladder cancer, encompassing physiological/practical support, informational support, psychological/emotional support, and social/spiritual support, with the aim of enhancing treatment adherence and quality of life.
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アクティブコンパレータ：Implementing routine urology outpatient infusion nursing
Includes: routine medical history inquiry and verification prior to infusion; monitoring of the patient's vital signs and clinical condition changes during infusion; routine verbal instructions on post-infusion precautions (such as increased water intake and frequent urination) after infusion; distribution of standard outpatient paper educational materials; and simple telephone follow-up in accordance with departmental routine procedures.
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Includes: Routine medical history inquiry and verification before infusion; Monitoring of the patient's vital signs and changes in condition during infusion; Routine verbal instructions on precautions after infusion (such as drinking plenty of water and urinating frequently); Distribution of routine outpatient paper educational leaflets; Conducting simple telephone follow-ups in accordance with the department's routine procedures.
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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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Clinical Treatment Adherence
時間枠：6 months after intervention
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Treatment adherence will be evaluated by infusion completion rate,calculated as (actual number of infusions received / total planned infusions prescribed) × 100%.
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6 months after intervention
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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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Bladder-cancer-specific quality of life
時間枠：Baseline、3 months、6 months after intervention
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This outcome will evaluate bladder-cancer-specific quality of life using the validated Chinese version of the EORTC-QLQ-NMIBC24 scale.
Higher scores correspond to greater symptom burden and worse quality-of-life status.
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Baseline、3 months、6 months after intervention
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Recruitment rate and infoermed consent rate
時間枠：Baseline
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Calculate the proportion of eligible patients who sign informed consent and formally enroll into the study among all screened eligible subjects.
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Baseline
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Patient Satisfaction and Acceptance
時間枠：3months after intervention
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A self-designed questionnaire with 5 items using 5-point Likert scale is adopted to score patients'satisfaction and acceptance of the supportive care program
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3months after intervention
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Satisfaction of supportive care needs
時間枠：Baseline, 3 months after intervention, 6 months after intervention
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The Short-Form Supportive Care Needs Survey (SCNS-SF34) is administered at three time points to evaluate changes in patients' supportive care needs between two groups.
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Baseline, 3 months after intervention, 6 months after intervention
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KY20260723-09
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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