Clinical study to assess the outcomes of a patient-centred survivorship care plan enhanced with big data and artificial intelligence technologies

Not Applicable

Completed

• Conditions: Breast cancer and colorectal cancer survivors; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN97617326
• Lead Sponsor: niversity of Maribor

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34391413/ protocol (added 16/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-26
• Study Completion: 2022-12-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1. Age =18 and =75 years at the moment of recruitment
2. Stable clinical situation, with a life expectancy of more than 2 years according to researcher opinion
3. Ability to understand study instructions, fulfil follow-up visits and sign an informed consent
4. Enough technology literacy that enables the patient to manage with mobile terminals (smartphones, smartphone apps, tablets)
5. Good internet connection in his/her place of residence

Exclusion Criteria

1. Life expectancy, in the physician opinion's, of less than 1 year
2. Diagnosis of dementia or cognitive decline that makes him/her unable to understand study information and/or sign the informed consent
3. Unable for self-management due to dependence on another person for medication compliance, or measuring blood pressure and daily weigh
4. Lacking decision capacity in relation to diet or preparing meals
5. Current participation in another clinical study
6. Patient has no further follow-up possibilities with enrolling investigation during the planned study period (such as anticipated relocation)
7. Patients with major depression or psychiatric medication that hinders their daily activity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived self-efficacy measured using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) and Strengths Self-Efficacy Scale (SSES) measured prior to the intervention (during recruitment), twice during the intervention (July 2021 and June 2022) and a final measurement at the end of the intervention (December 2022)

Secondary Outcome Measures

Name	Time	Method
1. Patient activation measured using the Patient Activation Measure (PAM) measured prior to the intervention (during recruitment), twice during the intervention (July 2021 and June 2022) and a final measurement at the end of the intervention (December 2022)<br>2. User acceptance measured using System Usability Scale (SUS) measured three times in July 2021(or August), June 2022 and December 2022<br>3. User experience measured with User Experience Questionnaire (UEQ) measured three times in July 2021(or August), June 2022 and December 2022<br>4. Inattentive and careless responding measured with Attentive Responding Scale (ASR) and the Directed Questions Scale (DQS) delivered randomly, since the researchers need to classify those participants that might fall into the Inattentive group and indicate why they are inattentive and try to remotivate them