Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors

NCT05401643 | Completed

• 1 other identifier: HCB/2020/0971
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Quality of Life; Survivorship

Keywords

Digital Health; mHealth; Quality of Life; Patient Support; eHealth

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life of cancer patients

  European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100.

  Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

• Change in Quality of Life specific to breast cancer patients

  European Organisation for Research and Treatment of Cancer Breast 23 (EORTC BR-23). Measured as 0-100.

  Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

Secondary Outcomes (10)

• Change in Anxiety and Depression

  Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

• Change in Loneliness

  Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

• Steps

  Continuous (12 months)

• Change in Weight

  Baseline and t= 12 months

• Change in Body Mass Index (BMI)

  Baseline and t= 12 months

Study Arms (2)

mHealth intervention

EXPERIMENTAL

Installation of the mHealth application Xemio in the participant's smartphones. Voluntary use of the application for 12 months. Outcome measures collected every 3 months.

Other: Xemio mobile application

Control

NO INTERVENTION

No application installed. Outcome measures collected every 3 months.

Interventions

Xemio mobile application OTHER

The study consists in a mHealth intervention provided through the Xemio mobile application for breast cancer survivors. This application is installed in the personal smartphones of the participants after they are randomized in the mHealth intervention group. The Xemio app components are symptom tracking, up-to-date calendar of events organized by patient's organizations, virtual talks with experts, articles regarding new information of the disease, physical activity tracking, and evidence-based information regarding symptoms, non-pharmacological treatments for side effects, and information about common drugs to treat breast cancer. The participants can freely use the Xemio mobile application for a total of 12 months. The control group does not have access to the Xemio application for the duration of the study but they are offered access to it at the completion of the intervention. The participants of both arms continued to receive the usual care from their oncology teams.

mHealth intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• Fundacion iSYS, internet, salud y sociedad: collaborator

Study Sites (1)

Hospital Clínic

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Imma Grau, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)