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Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.

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ClinicalTrials.gov Identifier: NCT02921724
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Drug accountability comparison [ Time Frame: 3 years ]
    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.
  • Toxicity reporting comparison [ Time Frame: 3 years ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02921724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • System acceptability: HADS questionaire [ Time Frame: 3 years ]
    HADS questionaire will be analyzed using the Wilcoxon rank-sum test
  • System acceptability: FACT-B questionaire [ Time Frame: 3 years ]
    FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
  • System usability: system usability scale (SUS) questionaire [ Time Frame: 3 years ]
    system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
  • System acceptability by the Q-pre questionaire [ Time Frame: 3 years ]
    System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
  • System acceptability by the Q-post questionaire [ Time Frame: 3 years ]
    System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
  • System acceptability by semi-structured interviews [ Time Frame: 3 years ]
    System acceptability by semi-structured interviews using content and template qualitative sociological analysis
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • System acceptability: HADS questionaire [ Time Frame: 3 years ]
    HADS questionaire will be analyzed using the Wilcoxon rank-sum test
  • System acceptability: FACT-B questionaire [ Time Frame: 3 years ]
    FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
  • System usability: system usability scale (SUS) questionaire [ Time Frame: 3 years ]
    system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
  • System acceptability by the Q-pre questionaire [ Time Frame: 3 years ]
    System acceptability by the Q-pre questionaire using content and template qualitative socialogical analysis
  • System acceptability by the Q-post questionaire [ Time Frame: 3 years ]
    System acceptability by the Q-post questionaire using content and template qualitative socialogical analysis
  • System acceptability by semi-structered interviews [ Time Frame: 3 years ]
    System acceptability by semi-structered interviews using content and template qualitative socialogical analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
Official Title  ICMJE Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Cancer
  • Oral Drug Administration
Intervention  ICMJE Device: TreC-Onco

TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention:

  1. Mobile diary app. This is an Android app (for Android version 2.2 and higher) that allows patients to record parameters related to their health state (e.g. medications; blood pressure, weight, fever; side-effects or other symptoms) through a mobile device. Data are stored in a central database and are made available in real time to health professionals through a web dashboard on the TreC server or through a tablet app.
  2. Web dashboard. Through this, oncologists can check patient data, monitoring their side-effects and adherence to prescriptions. The Dashboard is optimized for the Firefox browser in version 7 or higher.
Study Arms  ICMJE Experimental: 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.
Intervention: Device: TreC-Onco
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alessandro Passardi, MD +39 0543 739238 alessandro.passardi@irst.emr.it
Contact: Oriana Nanni, PhD +390543739100 oriana.nanni@irst.emr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921724
Other Study ID Numbers  ICMJE IRST100.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor  ICMJE Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators  ICMJE Kessler Foundation
Investigators  ICMJE
Study Chair: Alessandro Passardi, MD IRST IRCCS, Meldola (FC)
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP