Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain
Comparison of Cancer Pain Patients With or Without Mini Program
調査の概要
詳細な説明
Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.
To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:QiuLing Zhao
- 電話番号:5305 0591-83660063
- メール:qlzhao8@163.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients aged 18 years or older;
- Be able to read Chinese and use a mobile phone;
- Histologically or cytologically confirmed solid tumor;
- Diagnosed chronic cancer pain
- Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form.
Exclusion Criteria:
- Illiterate person;
- Incompetence;
- Inability to complete the pain assessment;
- Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study;
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: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 |
---|---|
実験的:a mini program trial group
Pharmacists conducted a standardized education session to teach the participants how to operate the mobile phone, use mini program, assess pain.
The participants in the trial group were asked to complete initial and final pain assessment questionnaires and Medication compliance on the mobile phones provided to them.
Participants were encouraged to use mini program as much as possible to record their pain status.
|
To design, construct, and test the mini program in patients managing cancer pain
他の名前:
|
偽コンパレータ:a control group
The control group received conventional pharmaceutical care.
Initial and final pain and Medication compliance data were collected.
Before the patient was discharged from the hospital, the clinical pharmacist conducted detailed medication education (including medication methods, prevention and treatment of adverse reactions, and precautions) and asked the patient to attempt to maintain a paper version of the pain diary.
|
conventional pharmaceutical care
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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 |
---|---|---|
Change in pain score
時間枠:Change from baseline at four weeks after discharge
|
Comparison of pain score of cancer pain patients with or without mini program.
Pain score will be assessed by using numeric rating scale (NRS).
An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."
|
Change from baseline at four weeks after discharge
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in medication adherence
時間枠:Change from baseline at four weeks after discharge
|
The investigators will measure the change in medication adherence via Morisky Scale.
Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.
|
Change from baseline at four weeks after discharge
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Incidence of adverse events
時間枠:Up to four weeks after discharge
|
Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0.
Number of subjects who experienced an adverse event in this study is presented.
|
Up to four weeks after discharge
|
Change in quality of life
時間枠:Change from baseline at four weeks after discharge
|
Comparison of quality of life of cancer pain patients with or without mini program.
Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D).
|
Change from baseline at four weeks after discharge
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
がんの痛みの臨床試験
-
Dexa Medica Group完了
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
mini programの臨床試験
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Universitaire Ziekenhuizen KU LeuvenCHU UCL Namurまだ募集していません
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Children's Health積極的、募集していない
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Brown UniversityHarvard University; West Virginia University; Canandaigua VA Medical Center; The Warren Alpert Foundation募集