Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
This is a prospective testing-validation, interventional, non-pharmacological study on a new app for oral anticancer therapy management.
A total of 80 patients will be considered: 20 evaluable patients in the training step; 60 patients in the validation step. In the training step will be considered evaluable the patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment performed and questionnaires self-administered.
Patients will be visited every 6 weeks. In the training step, patients will remain under observation for a minimum of 6 weeks, until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients enrolled in the validation step will remain under observation until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24 weeks.
The objective of this study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, improving adherence, preventing complications at home, toxicities, improper treatment reductions or interruptions, emergency accesses and to assess the system usability and acceptability by patients and health professionals, integration in the hospital workflow, monitoring over time patient perceived levels of quality of care, quality of life, social support, anxiety, and self-care capability.
調査の概要
詳細な説明
This is a prospective, interventional, non pharmacological study for testing-validation of a new app for optimising home management of oral therapies for cancer treatment.
All patients will be treated according to the local clinical practice. Enrolment period: 8 (training step) + 12 (validation step) months. Total duration of the study: 36 months. This is a multicenter study. Objective of the study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, and to assess the system usability and acceptability by patients and health professionals.
Eligible patients must meet the following criteria:
- adult 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed);
- sufficient ability to manage mobile devices after basic training course held at baseline;
- clear understanding of the Italian language;
- written informed consent.
Health professionals and patients define the items of the system through participatory design techniques (e.g. focus group sessions, joint review).
To define whether the system is capable of monitoring patient adherence, the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable. A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient at the clinical visit. The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 or more toxicity data reported by the patient at the time of the visit is recorded in the app.
To investigate system usability and acceptability, Functional Assessment of Cancer Therapy-General (FACT-G) and Hospital Anxiety and Depression Scale (HADS) questionnaires will be used. Scores will be subdivided into different subscales and analyzed using the Wilcoxon rank-sum test. Two new questionnaires have been developed and will be used to evaluate patient expectations of the system, and system acceptability + patient-doctor communication. An internationally validated questionnaire translated into Italian on system usability (SUS) will be also administered at the end of observation. Conversational interviews will be audio-recorded, transcribed and analyzed.
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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Bergamo、イタリア、24127
- Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
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Meldola (FC)、イタリア、47014
- Irst-Irccs
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Trento、イタリア、38123
- Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento
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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
Inclusion Criteria:
- ECOG-Performance Status (PS) less or equal to 1;
- life expectancy > 12 weeks;
- candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed);
- clear understanding of the Italian language;
- subjects who are, in the opinion of the Investigator, able to understand this study, to cooperate with the study procedures and able to manage mobile devices after basic training course held at baseline;
- written informed consent
Exclusion Criteria:
- Patients receiving also intravenous anticancer 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:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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:Cancer patients undergoing oral therapy
At the time of therapy prescription, patients candidate for oral therapy with capecitabine or sunitinib will be provided with informations on the side-effects of therapy and on the use and functions of the mobile diary app TreC-Onco.
Patients are required to manually insert data into the mobile diary app at least once a day.
Patients will be visited every 6 weeks.
During the visit, the clinician will compare adherence and toxicity data entered into the mobile diary app with those directly reported by the patient and by drug accountability.
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TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention:
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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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Drug accountability comparison
時間枠:3 years
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the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit.
A difference in the number of pills within +/- 10% will be considered acceptable.
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3 years
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Toxicity reporting comparison
時間枠:3 years
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A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient/detected by the doctor at the clinical visit.
The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 toxicity data reported by the patient at the time of the visit is recorded in the app.
A comparison will be made between the adverse event start time reported by the system and the time of data-entry by the patient into the system.
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3 years
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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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System acceptability: HADS questionaire
時間枠:3 years
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HADS questionaire will be analyzed using the Wilcoxon rank-sum test
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3 years
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System acceptability: FACT-B questionaire
時間枠:3 years
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FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
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3 years
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System usability: system usability scale (SUS) questionaire
時間枠:3 years
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system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
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3 years
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System acceptability by the Q-pre questionaire
時間枠:3 years
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System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
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3 years
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System acceptability by the Q-post questionaire
時間枠:3 years
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System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
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3 years
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System acceptability by semi-structured interviews
時間枠:3 years
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System acceptability by semi-structured interviews using content and template qualitative sociological analysis
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3 years
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協力者と研究者
捜査官
- スタディチェア:Alessandro Passardi, MD、IRST IRCCS, Meldola (FC)
出版物と役立つリンク
一般刊行物
- Passardi A, Foca F, Caffo O, Tondini CA, Zambelli A, Vespignani R, Bartolini G, Sullo FG, Andreis D, Dianti M, Eccher C, Piras EM, Forti S. A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial. J Med Internet Res. 2022 Jan 26;24(1):e27349. doi: 10.2196/27349.
- Passardi A, Rizzo M, Maines F, Tondini C, Zambelli A, Vespignani R, Andreis D, Massa I, Dianti M, Forti S, Piras EM, Eccher C. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study. BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617.
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。
癌の臨床試験
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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
TreC-Oncoの臨床試験
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Istituto Scientifico Romagnolo per lo Studio e...募集
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Azienda Provinciale per i Servizi Sanitari, Provincia...Ministero della Salute, Italy; Fondazione Bruno Kessler; Provincia Autonoma di Trento; TrentinoS...募集
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Centre Hospitalier Universitaire de Saint EtienneInstitut de Cancérologie de la Loire; Centre Antoine Lacassagne終了しました
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A2 Biotherapeutics Inc.Tempus AI募集癌 | 結腸直腸腫瘍 | 大腸がん | 膵臓の新生物 | 膵臓癌 | NSCLC | 固形腫瘍 | 非小細胞肺がん | 大腸がん転移性 | 膵臓がん | 結腸直腸腺癌 | 固形腫瘍、成人 | CRC | NSCLC、再発 | 非小細胞肺がんの再発 | 非小細胞扁平上皮肺がんアメリカ