Web-based Intervention for Long-term Breast Cancer Survivors

NCT05322460 | Recruiting

• 1 other identifier: UPNA-CUMACA-B2022
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long-term Effects of Cancer Treatment; Long-term Effects Secondary to Cancer Therapy in Adults

Keywords

Cancer survivors; Long-Term Cancer Survivors; Long Term Cancer Survivors; Survivorship

Outcome Measures

Primary Outcomes (3)

• Quality of life Cancer Survivor (QOL-CS)

  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.

  Changes from baseline, 3-months, 6 months, and 9 month

• Self-Efficacy for Managing Chronic Disease

  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

  Changes from baseline, 3-months, 6 months, and 9 month

• Sociodemographic data of LS-BC

  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.

  Baseline

Secondary Outcomes (1)

• Client Satisfaction Questionnaire (CSQ-8)

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: CUMACA-M Program

Control group

NO INTERVENTION

Usual care in the nursing consultation in primary care

Interventions

CUMACA-M Program OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cristina García-Vivar: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Public University of Navarre

Pamplona, 31008, Spain

RECRUITING

Related Publications (1)

• Pimentel-Parra GA, Soto-Ruiz N, Escalada-Hernandez P, San Martin-Rodriguez L, Garcia-Vivar C. EHealth intervention for quality of life in long-term breast cancer survivors: Randomized controlled trial. J Natl Cancer Inst. 2026 Jan 24:djag020. doi: 10.1093/jnci/djag020. Online ahead of print.

  PMID: 41581214 DERIVED

Study Officials

• Cristina Garcia Vivar, PhD

  Universidad Pública de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina García-Vivar, PhD

CONTACT

+34948166150; cristina.garciavivar@unavarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 11, 2022
• Study Start: December 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: November 1, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)