Long-term Effects of Cancer TreatmentCUMACA-MNCT05322460
Web-based Intervention for Long-term Breast Cancer Survivors
A study testing CUMACA-M Program in people with Long-term Effects of Cancer Treatment and Long-term Effects Secondary to Cancer Therapy in Adults, run by Cristina García-Vivar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Long-term Effects of Cancer Treatment, Long-term Effects Secondary to Cancer Therapy in Adults
- What is being tested?
- CUMACA-M Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Public University of Navarre
Pamplona, 31008
About this study
Official title: A Web-based Tailored Intervention to Improve the Quality of Life of Long-term Breast Cancer Survivors. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Long-term Effects of Cancer Treatment, Long-term Effects Secondary to Cancer Therapy in Adults
- Being tested
- CUMACA-M Program
- Keywords
- Cancer survivors, Long-Term Cancer Survivors, Long Term Cancer Survivors, Survivorship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUMACA-M ProgramOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CUMACA-M Program |
| Control group | No intervention | Usual care in the nursing consultation in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
Client Satisfaction Questionnaire (CSQ-8)
The satisfaction with the CUMACA-M Program will be measured using the Spanish version of the Client Satisfaction Questionnaire (CSQ-8) (Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In Maruish M (Ed). 2004). This scale is structured into 8 items with has five response options (from very dissatisfied to very satisfied).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Dec 2023
- Primary completion30 Sep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Long-term Effects of Cancer TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristina García-Vivar
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Cristina García-Vivar, Fundacion Miguel Servet
- Investigators
- Cristina Garcia Vivar, PhD, Principal investigator, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322460
- Sponsor's protocol ID
- UPNA-CUMACA-B2022
- Acronym
- CUMACA-M
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pimentel-Parra GA, Escalada-Hernandez P, San Martin-Rodriguez L, Garcia-Vivar C, Soto-Ruiz N. Effectiveness of an eHealth intervention to improve quality of life in long-term breast cancer survivors: a 9-month randomized controlled trial. J Natl Cancer Inst. 2026 Sep 16:djag328. doi: 10.1093/jnci/djag328. Online ahead of print.
PubMed 42747290Pimentel-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 Jun 1;118(6):1025-1031. doi: 10.1093/jnci/djag020.
PubMed 41581214
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Tailored Intervention to Improve the Quality of Life of Long-term Breast Cancer Survivors. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05322460
- Acronym / sponsor ID
- CUMACA-M / UPNA-CUMACA-B2022
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Cristina García-VivarUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: CUMACA-M ProgramThe 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 |
| Control group | No intervention | –Usual care in the nursing consultation in primary care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUMACA-M ProgramThe 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 | Intervention group |
Primary outcome
Quality of life Cancer Survivor (QOL-CS)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42747290Pimentel-Parra GA, Escalada-Hernandez P, San Martin-Rodriguez L, Garcia-Vivar C, Soto-Ruiz N. Effectiveness of an eHealth intervention to improve quality of life in long-term breast cancer survivors: a 9-month randomized controlled trial. J Natl Cancer Inst. 2026 Sep 16:djag328. doi: 10.1093/jnci/djag328. Online ahead of print.
- Derived from this study: PubMed 41581214Pimentel-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 Jun 1;118(6):1025-1031. doi: 10.1093/jnci/djag020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Garcia Vivar, PhD principal investigator
Universidad Pública de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CUMACA-M Program in people with Long-term Effects of Cancer Treatment and Long-term Effects Secondary to Cancer Therapy in Adults, run by Cristina García-Vivar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina García-Vivar, PhD (+34948166150, cristina.garciavivar@unavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life Cancer Survivor (QOL-CS) (time frame: Changes from baseline, 3-months, 6 months, and 9 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.