Clinical trial NCT05322460: Web-based Intervention for Long-term Breast Cancer Survivors
Official title: A Web-based Tailored Intervention to Improve the Quality of Life of Long-term Breast Cancer Survivors. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2022-04-11
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Hypothesis: A web-based tailored intervention, based on the prevention and management of physical and psychosocial late effects due to cancer treatment and aimed at improving the coexistence of long-term breast cancer, will be more effective in improving quality of life and self-efficacy for the management of late sequelae from Primary Care, than conventional care offered in Primary Care. Aim: To design, implement and evaluate the effectiveness of a web-based tailored intervention, based on artificial intelligence, to improve the quality of life of long-term survivors of breast cancer and self-efficacy for the management of late sequelae from Primary Healthcare. Methodology: Randomized controlled trial (following the Medical Research Council methodological framework). Phase I. Design of a personalized digital intervention based on the results of a review of the available evidence on the needs of long-term survivors (LS-BC) of breast cancer and agreed with a panel of experts. It will be designed in web/mobile application format. The use of algorithms will allow the personalization of the contents according to the needs. Phase II. Piloting: Pre-experimental design pretest-postest with one group, by means of a convenience sampling with LS-BC women, who meet the selection criteria. The collection of sociodemographic and clinical data, as well as the variables under study; quality of life (QOL-BC), self-efficacy in the management of cancer sequelae (Self-Efficacy for Managing Chronic Disease). The participants will use a web application and will test the usability and functionality. Phase III. Implementation of the intervention: Randomized controlled trial. Random sampling of LS-BC and random assignment to the intervention group (CUMACA-M program) or control group (standard care). A protocol will be designed that allows the collection of data and variables (Phase II) and satisfaction with the intervention (CSQ-8), at pre-intervention, and at 3, 6 and 9 months.

Eligibility criteria: 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 outcomes:
measure: Quality of life Cancer Survivor (QOL-CS)
timeFrame: Changes from baseline, 3-months, 6 months, and 9 month
measure: Self-Efficacy for Managing Chronic Disease
timeFrame: Changes from baseline, 3-months, 6 months, and 9 month
measure: Sociodemographic data of LS-BC
timeFrame: Baseline
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
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