Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05322460 |
| Other study ID # |
UPNA-CUMACA-B2022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
April 2022 |
| Source |
Fundacion Miguel Servet |
| Contact |
Cristina García-Vivar, PhD |
| Phone |
+34948166150 |
| Email |
cristina.garciavivar[@]unavarra.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
