Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

At the baseline visit, each patient assigned to arm A will be provided with the electronic diary (installed on a smart phone or tablet), the oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the electronic diary, and the user manual will also be given. This app allows patients to record parameters related to their health state (e.g. medications, blood pressure, weight, fever, side effects or other symptoms) and through the "alarm" function, it reminds the patient to take the tablets, indicating the exact dosage. In addition, the patient can also indicate the dose reduction or the omission.

Patients assigned to arm B will be provided with a paper diary, oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the paper diary.

TreC-Onco

Paper diary

Patrizia Serra, Dr

Oriana Nanni, PhD

Orazio Caffo, MD

Alessandro Passardi, MD

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

A total of 124 patients will be considered.

Patients will be randomized 1:1 to one of the following interventions:

A. electronic diary B. paper diary The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

The secondary objectives of the study are:

1. describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription),
2. describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire
3. description of the costs related to therapeutic non-adherence. A total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached.

Eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): A. electronic diary B. paper diary The electronic diary consist of an Android app (for Android version 2.2 and later) for mobile devices, which acts as a diary for the patient.

Adherence will be assessed at each treatment cycle by counting the remaining tablets. For patients with disease progression within six treatment cycles, the assessment of adherence and therefore the count of the remaining tablets will end on the date of progression.

Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology

Data available for sharing: Individual participant data that underlie the results reported in the pubblication, after deindentification (text, tables, figures and appendices

To assess the effectiveness of the electronic diary in improving adherence to oral therapy.

Adherence will be assessed at each treatment cycle by counting the remaining tablets, and tested using Fisher's exact test. The number of pills counted by the system will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit.

to describe the reasons for non-adherence to treatment in each group (e.g. forgetfulness, side effects, misunderstanding of the prescription) through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

describe the patient's compliance with the different strategies (paper diary or electronic) through a short questionnaire. Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

description of the costs associated with the lack of therapeutic adherence, both in terms of costs for drugs and overall health costs (hospitalizations, health services, access to the Emergency Department) (IRST center only). Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Immune System Diseases

Hypersensitivity

Robert Friedman, MD

The purpose of this study is to develop a tool that can more accurately assess the intensity and kind of physical activity that a person performs. The experimental tool, which will use a mobile computing device as a way of automatically identifying when a certain activity is being performed and at what intensity, will be tested against a self reported paper diary of activities performed on a day to day basis. It is hoped that this study will increase understanding of the health benefits of certain types of physical activity performed in the home.

Engaging in regular physical activity that requires a moderate to vigorous effort is related to good health and a reduced risk of a multitude of diseases. Currently physical activity and health promotion research is limited by self- report data that is confounded by participants' ability to accurately remember and record their physical activity. A potentially new method of accurately assessing moderate-intensity physical activity is called context sensitive- ecological momentary assessment (CS-EMA). Mobile computing devices (personal computing devices, PDAs) that automatically identify when a specific type of physical activity (e.g., moderate-intensity physical activity) is being performed has the potential to provide valuable objective data for naturalistic, experimental, and clinical intervention research purposes, and has the potential for educational, recreational, and clinical applications. The goal of this exploratory study is to assess the accuracy of two methods of collecting data on moderate-intensity physical activity. The study will compare the use of a paper diary to collect self-reported data on moderate-intensity physical activities performed throughout the day to self-reported data collected using ecological momentary assessment methods which are facilitated by a PDA that cues the participant to record when specific intensity levels of physical activity are achieved. This study will also develop algorithms that will automatically identify specific types of physical activities being performed. The data collected from the heart rate monitor, motion sensor, and information requested directly from the participant via the PDA interface will be used to train pattern recognition systems to classify the intensity and type of physical activity being performed by the participant. This study will contribute to research on context- awareness and human activity recognition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology	NCT04826458	Cancer Solid Tumor Hematologic Mal... Oral Drug Admin...	TreC-Onco Paper diary	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
The Development and Testing of an Electronic Tool to Measure Physical Activity in Domestic Settings	NCT00207181	Cancer		18 Years -	Boston Medical Center
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology	NCT04826458	Cancer Solid Tumor Hematologic Mal... Oral Drug Admin...	TreC-Onco Paper diary	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for paper diary

Every month we try and update this database with for paper diary cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for paper diary

Every month we try and update this database with for paper diary cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for paper diary cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.