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Completed

NCT Number: NCT05401643

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases Survivorship

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

  • Fundacion iSYS, internet, salud y sociedad

Registry information

Official study title

Evaluación Del Impacto de Una intervención Multidimensional, Con Herramientas TIC, en la Calidad de Vida de Las Pacientes Supervivientes al cáncer de Mama

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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