Clinical trial NCT05401643: Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors
Official title: Evaluación Del Impacto de Una intervención Multidimensional, Con Herramientas TIC, en la Calidad de Vida de Las Pacientes Supervivientes al cáncer de Mama
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Quality of Life
Survivorship
Keywords: Digital Health
mHealth
Quality of Life
Patient Support
eHealth
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Fundacion iSYS, internet, salud y sociedad
First posted: 2022-06-02
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a prospective, longitudinal, randomized 1:1 trial, with two arms: a control group and an intervention group. The intervention will be 12 months long for each participant. There will be a total of 150 participants. Half (75) will comprise the control group and half (75 more) the intervention group. Only the intervention group will have access to the Xemio mobile app.
Primary purpose: SUPPORTIVE_CARE

Brief summary: mACMA is a pilot study that is developed for breast cancer survivors of the Hospital Clinic of Barcelona. The objective of this study is to evaluate the progress in quality of life through the introduction of a mobile phone App that allows for symptom tracking, physical activity tracking and a calendar of patient-oriented events organized by patient organizations. This study is a two-arm randomized clinical trial.

This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 875351.


Eligibility criteria: Inclusion Criteria:

* Previous diagnostic of breast cancer
* Free of disease at the time of randomization
* Signed consent form
* Possession of a smartphone and ability to use smartphone applications
* Patients belonging to the ACMA group o being treated at Hospital Clínic
* Without diagnosis of neurodegenerative disorders that prevent participation in the study

Exclusion Criteria:

* Acute process of cancer at the moment of recruitment
* Active treatment for cancer (chemotherapy, radiotherapy)
* Comorbidities such as heart failure NYHA class 4, COPD,...
* Inability to give informed consent

Primary outcomes:
measure: Change in Quality of Life of cancer patients
timeFrame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
measure: Change in Quality of Life specific to breast cancer patients
timeFrame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
Secondary outcomes:
measure: Change in Anxiety and Depression
timeFrame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
measure: Change in Loneliness
timeFrame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
measure: Steps
timeFrame: Continuous (12 months)
measure: Change in Weight
timeFrame: Baseline and t= 12 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and t= 12 months
measure: Change in Fat mass percentage
timeFrame: Baseline and t= 12 months
measure: Change in muscle mass percentage
timeFrame: Baseline and t= 12 months
measure: Change in Social Determinants of Health
timeFrame: Baseline and t= 12 months
measure: Symptoms reported with the Xemio mobile application
timeFrame: Continuous (12 months)
measure: Use of the Xemio mobile application
timeFrame: Continuous (12 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Imma Grau, PhD
role: PRINCIPAL_INVESTIGATOR
References: