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

• ClinicalTrials.gov Identifier: NCT05401643
• Recruitment Status: Recruiting
• First Posted: June 2, 2022
• Last Update Posted: June 7, 2022
• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Collaborator: Fundacion iSYS
• Information provided by (Responsible Party): Imma Grau, Hospital Clinic of Barcelona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Breast Neoplasms; Quality of Life; Survivorship	Other: Xemio mobile application	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: mHealth intervention; 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; 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.
No Intervention: Control; No application installed. Outcome measures collected every 3 months.

Outcome Measures

Primary Outcome Measures :

1. Change in Quality of Life of cancer patients [ Time Frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) ]
   European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100.
2. Change in Quality of Life specific to breast cancer patients [ Time Frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) ]
   European Organisation for Research and Treatment of Cancer Breast 23 (EORTC BR-23). Measured as 0-100.

Secondary Outcome Measures :

1. Change in Anxiety and Depression [ Time Frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) ]
   Hospital Anxiety and Depression Scale (HADS). Measured as 0-21, 0 being the best and 21 being the worst.
2. Change in Loneliness [ Time Frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) ]
   Three-Item Loneliness Scale. Measured as 0-9, 0 being the best, 9 being the worst.
3. Steps [ Time Frame: Continuous (12 months) ]
   Number of steps taken daily by study participants
4. Change in Weight [ Time Frame: Baseline and t= 12 months ]
   Weight (kg) measured with a bioimpedance scale
5. Change in Body Mass Index (BMI) [ Time Frame: Baseline and t= 12 months ]
   BMI (kg/m^2) measured with a bioimpedance scale
6. Change in Fat mass percentage [ Time Frame: Baseline and t= 12 months ]
   Fat mass percentage measured with a bioimpedance scale
7. Change in muscle mass percentage [ Time Frame: Baseline and t= 12 months ]
   Muscle mass percentage measured with a bioimpedance scale
8. Change in Social Determinants of Health [ Time Frame: Baseline and t= 12 months ]
   Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status
9. Symptoms reported with the Xemio mobile application [ Time Frame: Continuous (12 months) ]
10. Use of the Xemio mobile application [ Time Frame: Continuous (12 months) ]
    Time that the Xemio mobile application is open in minutes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Imma Grau, PhD; +34 692241233; igrau@clinic.cat

Contact: Clara Amat, MS; amat@clinic.cat

Locations

Spain

Hospital Clínic; Recruiting

Barcelona, Catalonia, Spain, 08036

Contact: Imma Grau, PhD

Sponsors and Collaborators

Fundacion Clinic per a la Recerca Biomédica

Fundacion iSYS

Investigators

• Principal Investigator: Imma Grau, PhD; Hospital Clinic of Barcelona

More Information

• Responsible Party: Imma Grau, Principal Investigator, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT05401643
• Other Study ID Numbers: HCB/2020/0971
• First Posted: June 2, 2022
• Last Update Posted: June 7, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data will not shared as it is stated in the approved informed consent and protocol approved by the institution's Ethics Committee. Some of the data collected in this study contains clinical information, hence it is sensible information that needs to remain private.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imma Grau, Hospital Clinic of Barcelona:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases