Ireland
--:--IST
Recruiting Not applicable

Web-based Intervention for Long-term Breast Cancer Survivors

NCT05322460 · tracked via the Priya Life Science Spain tracker
Sponsor
Cristina García-Vivar
Phase
Not applicable
Started
2023-12-15
Last updated
2025-09-30

Condition(s) studied

Long-term Effects of Cancer TreatmentLong-term Effects Secondary to Cancer Therapy in Adults

Investigational drug(s) / intervention(s)

CUMACA-M Program

CUMACA-M Program: The CUMACA-M Program will focus on a web-based tailored intervention, using artificial intelligence, for Long-Term Survivors of Breast Cancer. It will be structured into modules related to the specific needs of LS-BS, including physical, psychological, and social needs

Study summary

The number of breast cancer survivors is growing. More cured women are becoming long-term survivors of breast cancer (LS-BC) at least 5 years after diagnosis and after treatment has been completed. Some of these LS-BC return to daily life without any problems; however, in many cases, they experience and have to deal with physical sequelae (chronic fatigue, pain, etc.) psychological sequelae (anxiety, depression, fear of recurrence, etc.) and social sequelae (altered interpersonal relationships, difficulty in returning to work, etc.). For many LS-BC, these health problems are not being met by health professionals. Thus there is a need to promote greater continuity and coordination between specialized oncology care and primary health care in order to enhance specific follow-up of these women in the community. However, the role of the primary health care team in the provision of care in the long-term cancer survival is not clearly defined and few actions have been aimed at improving care activities, standardizing procedures and protocols, developing documentation and registries and updating the training of health care professionals. Therefore, this study aim to design, implement, and evaluate a web based tailored intervention, using artificial intelligence, to improve the quality of life of long-term breast cancer survivors, and self-efficacy for the management of late sequelae from primary care.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * having been diagnosed with breast cancer * having completed active oncological treatments (chemotherapy and/or radiotherapy) in a period of time greater than five years, * be free of disease at the time of data collection * be a woman and over 18 years of age * have knowledge of Internet use. Exclusion Criteria: * Women with a diagnosis of cancer other than breast cancer * Recurrence of cancer or metastasis that causes a new treatment * Being in active treatment for recurrence or new cancer * Being a man

Primary outcome measure(s)

  • Quality of life Cancer Survivor (QOL-CS) — Changes from baseline, 3-months, 6 months, and 9 month
    The QOL-CS, Spanish version (Ferrell B, Hassey-Dow K, Grant M. Quality of Life Patient/Cancer Survivor Version (QOL-CS) \[Internet\]. Measurement Instrument Database for the Social Science. 2012). Scale specific for cancer survivor. Likert-type scale with 10 options (1 extremely poor and 10 excellent) with 41 items that measure the four domains of quality of life: physical, psychological, social and spiritual well-being.
  • Self-Efficacy for Managing Chronic Disease — Changes from baseline, 3-months, 6 months, and 9 month
    The Self-Efficacy for Managing Chronic Disease- 6-Item Scale (SEMCD-6) (Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014; 67(11): 1265-73). The scale is structured in 6 items related to symptom control, role performance, emotional state and communication with health professionals
  • Sociodemographic data of LS-BC — Baseline
    Sociodemographic data of the LS-BC (age, sex, marital status, educational level, employment status) will be collected by means of an ad hoc questionnaire at the beginning of the intervention.

Trial sites (1)

FacilityCityRegionStatus
Public University of Navarre Pamplona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05322460 on ClinicalTrials.gov ↗ ← All trials in Spain