Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Group A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool.

Group B) a control group (n=80) who will receive standard care and information (oral and written).

The patients randomized to group A will receive verbal and written information regarding the digital information tool and how to use it, as well as verbal and written information about the study. They will also receive information about the different instruments and surveys they will be asked to answer at different occasions during the RT treatment period. The applied instruments for data collection will be administrated in person or by post at the baseline collection and by post (including pre-paid return envelope) on consecutive collections. Approximately 30 patients (in group A) will be asked to make regular notes in a notebook during the waiting period prior start of RT as well as during RT treatment period. Following completion of the RT treatment period individual in-depth and telephone interviews will take place with 10-12 patients that accept participation.

Digital information tool

maria brovall

This project uses participatory design combined with qualitative and quantitative methods to develop, explore and evaluate the usefulness of a digital information tool to prepare and support patients before, during and after RT as treatment for breast cancer.

The study is a prospective and longitudinal Randomised Control Trial (RCT) study with an Action Research (AR) participatory design approach, including mixed-method data collection, i.e., standardised instruments, interviews (face-to-face and telephone), diaries, observation, and time measurements. The timeline for the study is scheduled between autumn 2020 to spring 2022. The study will consist of two arms: A) an intervention group (n=80), who will receive standard care and information and the digital information tool; and B) a control group (n=80) who will receive standard care and information (verbal and written). Recruitment and randomisation will be completed at two hospitals in the South western part of Sweden.

As a pre-phase, a pilot study was performed for the development and testing of the digital information tool (Digi-Do), approved by the Regional Ethics Committee (Dnr 917-17) with 30 patients in total (15 women with breast cancer and 15 men with prostate cancer). According to the study's co-design, iterative methodology \[26-27 in manuscript\], changes have since been made to the digital information tool and a second version has now been developed for the full RCT. The present study has been approved by the Swedish Ethical Review Authority (Dnr 2020-00170). An ongoing systematic literature review will also guide the present study, and the project is registered in PROSPERO (PROSPERO;168073).

The digital information tool applied in this project is divided into two separate but coherent applications (apps) for mobile devices: one (VR-app) with a guided tour of the RT-department with a voice-over to describe 360 images to create a sense of actually having visited the department prior to start of RT, and one (information app) containing information obtained through the pre-treatment phase. If a VR-effect is not desirable, the patient can complete the simulated study-visit on their mobile phone or tablet as well as present the images in the browser of an integrated media player. Three areas of information are available in the information app: 1) Q\&As from the existing written information, presented both in writing and a recorded voice; 2) practical information, such as maps, public transportation options with relevant links to public transport, telephone numbers, and information about possibilities for staying at the patient hotel; and 3) three short animated films about cancer and physical activity during RT.

Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer

Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer to be Involved and Prepared Before, During, and After Start of Radiotherapy Treatment

The individual in-depth and/or telephone interviews will take place on two occasions (1-4 weeks and 6 months post-RT completion) and with at least ten of the patients who have accepted participation and have made regular notes. Questions will include topics such as their experiences of receiving the information through the digital information tool during the waiting time and treatment period, of using the digital information tool, to what extent the digital information has affected their involvement and preparedness for the radiation treatment, as well as their experiences during the time since the end of RT

The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress

The Swedish version of the General Self-efficacy (GSE) Scale. The GSE scale consists of 10 items rated on a fourpoint Likert scale (''not at all true'' to ''exactly true'').

The communicative and critical health literacy scale - Swedish version. The first three items include statements focusing on the capacity for collecting, extracting, and understanding relevant health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse).

The Swedish Functional Health Literacy scale scale comprises five items about persons' skills in reading and understanding health information. Each item is rated on a 4-point scale, ranging from 1 (never=better) to 4 (often=worse).

The The eHealth Literacy Questionnaire (eHLQ) is a psychometrically robust multidimensional tool designed to be used to understand and evaluate people's interaction with digital health services

Ten patients respectively from groups A and B will be consequently asked to participate in the time measurement and observational part of the study (n=20). All planned treatments for the first week of RT (n=5), and, additionally, one session in the last week of treatment, will be measured based on seven timepoints; patient enters door of RT room, patient lies on table, first image, first field beam on, last field beam on, patient leaves table, and patient leaves RT room. This will result in approximately 120 points of measurement. During each RT session, observations of questions asked by patients and staff will be documented in a protocol, including what subjects are addressed, who initiates the question, and whether, how, and to where the staff refers the patient for further information.

Jonkoping University

Associate Professor

Substance Related Disorders

Symptoms and General Pathology

Drug-Related Side Effects and Adverse Reactions

Nausea

Vomiting

Signs and Symptoms, Digestive

This intervention is a serious game which allows older adults under treatment for cancer to practice making self-care decisions for an avatar that is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with the research assistant about choices related to managing nausea and vomiting at home

The control group will receive standard education related to managing nausea and vomiting and will have the opportunity to participate in the intervention at the end of the study

Participants in the intervention group will be asked to play the serious game on an iPad at their first chemotherapy treatment visit. The control group will be able to play at time 6.

eSSET-CINV

Victoria Loerzel, PhD

Michael Owings

Deborah Anglade, PhD

Aurea Middleton, MSN

The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.

The goal of this study is to increase the use of preventative self-management behaviors for nausea and vomiting in older adults receiving chemotherapy to reduce negative outcomes and emergency or hospital admissions. Early reinforcement of standard education and re-framing any preconceived beliefs about the ability of nausea and vomiting to be managed will increase preventative self-management behaviors and improve patient outcomes. Participants will be in the study for 6 chemotherapy treatment cycles. This could be 12 to 24 weeks depending on if they receive treatment every 2, 3 or 4 weeks.

Participants will be randomly assigned to either an intervention or control group.

Serious Gaming for Chemotherapy-induced Nausea and Vomiting

Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial

any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)

The Symptom Management Checklist will measure the presence and severity of nausea and vomiting. Participants will be sent a text link every day for 6 days after chemotherapy or complete this data on a form at home. This starts right after time 1. Nausea will be reported on a 0-10 scale. Higher numbers equal more nausea.

The Symptom Management Checklist will measure self-management behaviors and preventive behaviors for CINV. Participants will be sent a text link every day for 6 days after chemotherapy or complete this data on a form at home. This starts right after Time 1.

The Symptom Representation Questionnaire Part 1 is a 24 item self-report measure that will be used to identify the presence and severity of common treatment-related side effects (0 to 10 scale). Higher numbers indicate more severe symptoms. This measure asks participants to think about their symptoms over the last week

The Symptom Representation Questionnaire Part 2 has 15 questions related to cognitive beliefs about nausea. Sub scales examine symptom cause, timeline, cure/control, and consequences. An agreement type Likert scale is used.

The EORTC-30 will measure quality of life at each treatment cycle. Higher scores mean better quality of life

Orlando Health, Inc.

University of Miami

National Institute of Nursing Research (NINR)

University of Central Florida

Patients in the intervention group will be part of a renewed care pathway supported by digital tools.

Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.

In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.

Health Professional Consortium

Holis Dashboard - Holis Patient App

Hans Wildiers, prof. dr.

Cindy Kenis, PhD

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals.

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals. The GerOnTe project consists of two identical trials in two different European geographical areas, FRONE in France and TWOBE in Belgium and the Netherlands. The goal of two identical trials is to take into account the role of health care contexts in the implementation, effectiveness and efficiency of the GerOnTe intervention. A stepped wedge randomized controlled trial, where the randomized clusters will be participating hospitals, will be conducted in eight academic and general hospitals in total with a follow-up at 3, 6, 9 and 12 months after study inclusion. Patients will be recruited in all participating hospitals in the period between the cancer diagnosis and the treatment decision.

stepped wedge randomized controlled trial (cross-over type)

Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.

Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study

Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS).

Three derived scores of the QLQ-C30 questionnaire are considered as primary endpoints:

* Normalized global health status score of the QLQ-C30 (version 3.0) (score 0-100),
* Normalized score of the physical functioning scale of the QLQ-C30 (version 3.0) (score 0-100),
* Normalized score of the emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100).

A high score for a functional scale represents a high / healthy level of functioning.

A high score for the global health status / QoL represents a high QoL.

HRQOL evaluation was performed using EORTC QLQ-C30 Global Health Status Scale (GHS) and Quality of Life Questionnaire Elderly Cander Patients 14 (EORTC QLQ-ELD14) Global Health Status Scale (GHS).

* Normalized scores of global health status, physical functioning scale and emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100).
* Normalized scores of the QLQ-C30 symptom scales/items (score 0-100).
* Scores of QLQ-ELD14 scales/items (score 0-100).

A high score for the global health status / QoL in QLQ-C30 represents a high QoL.

A high score for a symptom scale / item represents a high level of symptomatology / problems.

High scores in QLQ-ELD14 indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.

Survival as the length of time from the start of treatment and death from any cause.

Progression-free survival (PFS) defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first.

Dependence score measured by Activities of Daily Living (ADL). The ADL scale includes six items (bathing, dressing, toileting, transferring, continence and feeding), with a score for each item scores ranging from one (able to perform the activity) to four (unable to perform the activity) (range: 6-24).

Proportion of patients living at home (range: 0-100%). The higher the percentage, the more patients live at home.

Number of completed chair stands in 30 seconds measured by the Chair Stand Test. Participants stand up repeatedly from a chair for 30 seconds.

The overall level of fitness or frailty of the older patients will be assessed by the 9-point Clinical Frailty Scale (CFS) (score: 1-9).

The higher the score, the less fit or more frail the older person is.

The ECOG Performance Status Scale (ECOG-PS) describes a patient's level of functioning in terms of their ability to care for themself, daily and physical ability (score: 0-5).

The higher the score, the less active the older person is.

The weight of a person (in kilograms) measured with a scale.

Patient anxiety measured by the Hospital Anxiety and Depression Scale (HADS). The 14 questions can be answered by a 4-point Likert scale (0-3). The odd questions (1, 3, 5, 7, 9, 11, 13) refer to fear (score: 0-21).

The higher a person scores on this questionnaire, the more complaints of anxiety he/she experiences.

Proportion of patients institutionalised (see definition) (range: 0-100%). Definition: Institutionalisation means that a patient moves permanently to an institution among which are considered retirement houses.

Proportion of patients with at leas one unscheduled hospitalisation and number of unscheduled hospitalisations per patient (see definition) (range: 0-100%).

Definition: Unscheduled hospitalisation includes any hospitalisation which has not been previously planned because of an unscheduled event (severe adverse event, complication of treatment, decompensation of morbidity) whatever it is linked or not to the emergency room.

Life years gained (LYG) in the cost per life years gained (CEA) derived from a clinical metric (overall survival/progression-free survival).

Quality-adjusted life years (QALYs) in the cost per QALY gained (CUA) calculated using utility assessed through normalised scores of EQ-5D-5L questionnaire. It includes the 5-level questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 5-digit code for EQ-5D-5L, which reflects how good or bad a health state is according to the preferences of the general population of a country/region (score: 11111-55555 (or 99999 for missing data)).

Total amount resulting from all direct (medical or non-medical) and indirect costs related to disease and care, collected during the 12 months of patient follow-up.

Total burden of the caregiver in health, psychological well-being, finances, social life and relationship with the patient will be obtained using the Zarit Burden Interview (ZBI) by adding the scores across all 22 items. Each question is scored on a 5-point scale (score: 0-88).

The higher the score, the heavier the caregiver burden.

Patient experience of person-centred coordinated care measured through the Person-Centred Coordinated Care Experience Questionnaire (P3CEQ) - 11 items in 5 domains: information and communication processes, care planning, transitions, goals and outcomes and decision making.

Patient satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the 21-items mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Patient version).

Physician and health-professional satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the adjusted version designed for health care providers of the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Provider version), consisted of 18 items.

Number of connections to the Holis Patient App.

Frequency of connections to the Holis Patient App.

Duration of logins and activities with the Holis Patient App,

Number of web-based meetings with Advanced Practice Nurse by site.

Number of Advance Practice Nurse (APN) consultations by site (and by patient).

Number of Patient Reported Outcome Measures (PROM's) dashboards completed by patient (Holis Patient App).

Number of health professional meetings (Multidisciplinary Tumour Boards (MTB) or other morbidities treatment decision) involving complete dashboards analysis by site.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer	NCT04394325	Breast Cancer	Digital informa...	18 Years -	Jonkoping University
Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer	NCT04394325	Breast Cancer	Digital informa...	18 Years -	Jonkoping University
Serious Gaming for Chemotherapy-induced Nausea and Vomiting	NCT05838638	Neoplasms Chemotherapy-in...	eSSET-CINV	60 Years -	University of Central Florida
Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.	NCT05423808	Geriatrics Medical Oncolog... Critical Pathwa... Digital Technol...	Health Professi... Holis Dashboard...	70 Years -	Universitaire Ziekenhuizen KU Leuven

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