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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Renal Cell Carcinoma

Interviews with 2 oncologists and 10 patients

Interviews with 15 patients

Hélène HOARAU, PhD

The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

At the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. The prognosis remains dark in spite of the advent of the targeted therapies from 2007. Actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\].

These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? In May 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the Teaching Hospital of Bordeaux, the therapeutic educational Federation, the Coordination Cancer Centre (3C), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients \[current approval\].

This program, built on the model of the TE in France, becomes here an object of research: MODAP (action-research).

From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research

From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

Quantitative data analysis of questionnaires about the health program satisfaction Participation rate to the program stages Attendance to the program stages Management of therapeutic plan : number of rendez-vous changed by the patient or healers

Management of therapeutic plan : number of rendez-vous change by the patient or healers, number of therapeutic education procedures stages versus the number realized, number of calls by nurses

University Hospital, Bordeaux

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Initial consultation with a trio oncologist / pharmacist / nurse; weekly telephone follow-up with a nurse between each treatment and follow-up visit with the oncologist at each renewal of treatment.

Initial consultation with the oncologist and follow-up visit with the oncologist

Initial consultation with a trio oncologist / pharmacist / nurse

managment of oral therapy

Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many side effects and patients are reluctant to report them because they are afraid that their treatment will be changed. But when these side effects are poorly managed, they can reduce adherence to treatment.

The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of oral anticancer treatments decreases the rate and duration of side effects.

The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy.

This randomized study is realized in patients with kidney or breast cancer.

Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many adverse effects (nausea, vomiting, digestive disorders, skin and mucous ...) that can significantly impact the quality of life. Patients are reluctant to report side effects because they are afraid that their treatment will be changed. But if these side effects are poorly managed, they can reduce adherence to treatment. The majority of devices are evaluated post-treatment and none relates to the treatment administration period.

The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of treatments decreases the rate and duration of digestive, cutaneous and mucosal side effects.

The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy (Xeloda® or Sutent®).

Optimizing the Management of Patients With Oral Therapy

Optimizing the Management of Patients With Oral Therapy: a Randomized Trial Evaluating the Impact of Management on the Occurrence of Side Effects

Side effects evaluated: digestive, cutaneous and mucosal grade 3 and 4

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
From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research	NCT02896790	Health Services...	Interviews with... Interviews with...	18 Years -	University Hospital, Bordeaux
Optimizing the Management of Patients With Oral Therapy	NCT03623490	Kidney Cancer Breast Cancer	managment of or...	18 Years -	Centre Georges Francois Leclerc
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 oral therapy

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