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

• ClinicalTrials.gov Identifier: NCT05401643
• Recruitment Status: Completed
• First Posted: June 2, 2022
• Last Update Posted: February 28, 2024
• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Collaborator: Fundacion iSYS, internet, salud y sociedad
• Information provided by (Responsible Party): Imma Grau, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: May 23, 2022
• First Posted Date: June 2, 2022
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2022)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 3, 2022)

• 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

Original Secondary Outcome Measures (submitted: May 27, 2022)

• 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) ]
  Physical activity monitoring
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Survivorship

Intervention

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.

Study Arms

• 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.
  Intervention: Other: Xemio mobile application
• No Intervention: Control
  No application installed. Outcome measures collected every 3 months.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 23, 2024): 110
• Original Estimated Enrollment (submitted: May 27, 2022): 150
• Actual Study Completion Date: June 30, 2023
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05401643
• Other Study ID Numbers: HCB/2020/0971
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

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.

• Current Responsible Party: Imma Grau, Hospital Clinic of Barcelona
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Original Study Sponsor: Same as current
• Collaborators: Fundacion iSYS, internet, salud y sociedad

Investigators

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

• PRS Account: Fundacion Clinic per a la Recerca Biomédica
• Verification Date: February 2024