Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT05401643|
Recruitment Status : Recruiting
First Posted : June 2, 2022
Last Update Posted : June 7, 2022
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Steps [ Time Frame: Continuous (12 months) ]Number of steps taken daily by study participants
- Change in Weight [ Time Frame: Baseline and t= 12 months ]Weight (kg) measured with a bioimpedance scale
- Change in Body Mass Index (BMI) [ Time Frame: Baseline and t= 12 months ]BMI (kg/m^2) measured with a bioimpedance scale
- Change in Fat mass percentage [ Time Frame: Baseline and t= 12 months ]Fat mass percentage measured with a bioimpedance scale
- Change in muscle mass percentage [ Time Frame: Baseline and t= 12 months ]Muscle mass percentage measured with a bioimpedance scale
- 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
- Symptoms reported with the Xemio mobile application [ Time Frame: Continuous (12 months) ]
- Use of the Xemio mobile application [ Time Frame: Continuous (12 months) ]Time that the Xemio mobile application is open in minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05401643
|Contact: Imma Grau, PhD||+34 email@example.com|
|Contact: Clara Amat, MSfirstname.lastname@example.org|
|Barcelona, Catalonia, Spain, 08036|
|Contact: Imma Grau, PhD|
|Principal Investigator:||Imma Grau, PhD||Hospital Clinic of Barcelona|