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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05401643
Recruitment Status : Recruiting
First Posted : June 2, 2022
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
Fundacion iSYS
Information provided by (Responsible Party):
Imma Grau, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE May 23, 2022
First Posted Date  ICMJE June 2, 2022
Last Update Posted Date June 7, 2022
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Breast Cancer
  • Breast Neoplasms
  • Quality of Life
  • Survivorship
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2022)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Imma Grau, PhD +34 692241233 igrau@clinic.cat
Contact: Clara Amat, MS amat@clinic.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05401643
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Fundacion Clinic per a la Recerca Biomédica
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fundacion iSYS
Investigators  ICMJE
Principal Investigator: Imma Grau, PhD Hospital Clinic of Barcelona
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP