Colon CancerNCT07347158
Effectiveness of Health Education as a Nursing Intervention in Improving Quality of Life and Reducing Symptoms of Anxiety and Depression in Ostomy Patients Following Digestive Surgery: A Quasi-Experimental Study.
A study testing Health Education in people with Colon Cancer and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
The proposed project is a prospective quasi-experimental study to be conducted at the Ostomy Clinic of the University Hospital Complex of Santiago de Compostela. The primary objective is to evaluate the effectiveness of health education as a nursing intervention in reducing anxiety and depression and improving the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Colitis Ulcerative
- What is being tested?
- Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2026to 31 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Patients with digestive ostomies, either permanent or temporary ostomies lasting more than 6 months, attending ostomy consultations.
- Volunteers with permanent digestive ostomies from the Santiago and Barbanza healthcare area.
- Patients who agree to participate in the study.
Who cannot join
- Terminal patients
- Patients with cognitive impairments
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
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15703
About this study
The proposed project is a prospective quasi-experimental study to be conducted at the Ostomy Clinic of the University Hospital Complex of Santiago de Compostela. The primary objective is to evaluate the effectiveness of health education as a nursing intervention in reducing anxiety and depression and improving the quality of life of ostomy patients following digestive surgery. The study will focus on adult patients who have undergone an elimination ostomy, excluding terminal patients and those with cognitive impairments.
The study involves clinical follow-up of patients from hospital admission to several months after completing the health education program. Validated scales will be used to measure quality of life, anxiety, and depression. The intervention will consist of health education workshops and continuous follow-up by specialized nursing staff.
- Conditions
- Colon Cancer, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Colitis Ulcerative
- Being tested
- Health Education
- Keywords
- ostomy, quality of life, anxiety, depression, Nursing care, Health education, stoma care
- Medical subject headings
- Colonic Neoplasms, Colitis, Ulcerative, Anxiety Disorders, Depression, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationOther
Session 1 (60 minutes) Patient Knowledge Assessment: Review understanding of ostomy care, including nutrition, device management, and early identification of stoma/skin complications.
Feedback and Support: Address gaps in knowledge based on ostomy consultations. Skills Workshop: Build confidence and self-efficacy in daily care, reducing anxiety about complications.
Session 2 (60 minutes) Mental Health and Quality of Life: Explain the link between ostomy and mental health; identify and manage anxiety/depression symptoms; promote healthy habits and social integration.
Mindfulness and Stress Management: Teach breathing and relaxation techniques to manage stress and improve body acceptance.
Guided Visualization: Focus on acceptance and confidence building. Action Plan: Summarize techniques and encourage regular practice. Session 3 Healthy Habits: Nutrition, exercise, rest, and stress management. Social Integration: Communication, participation, and support networks. Closing: Summary, resou
| Study group | Role | What they receive |
|---|---|---|
| Health education by virtual and smart-glasses | Experimental | Health education (emotional care, mindfulness, jacobson, quality of life, social, sexual, ...). Method: psicosocial/holistic Receives: Other: Health Education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Beck Depression Inventory
Measured: Baseline and at 3 months
36-Item Short Form Health Survey
36-Item Short Form Health Survey
Measured: Baseline and at 3 months
Beck anxiety inventory
Beck anxiety inventory
Measured: Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start4 Mar 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomás Mendoza Caamaño, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347158
- Sponsor's protocol ID
- 2024-389
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Education as a Nursing Intervention in Improving Quality of Life and Reducing Symptoms of Anxiety and Depression in Ostomy Patients Following Digestive Surgery: A Quasi-Experimental Study.
- ClinicalTrials.gov ID
- NCT07347158
- Acronym / sponsor ID
- 2024-389
- Conditions
- Colon Cancer, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Colitis Ulcerative
- Keywords
- ostomy, quality of life, anxiety, depression, Nursing care, Health education, stoma care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 4 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (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 proposed project is a prospective quasi-experimental study to be conducted at the Ostomy Clinic of the University Hospital Complex of Santiago de Compostela. The primary objective is to evaluate the effectiveness of health education as a nursing intervention in reducing anxiety and depression and improving the quality of life of ostomy patients following digestive surgery. The study will focus on adult patients who have undergone an elimination ostomy, excluding terminal patients and those with cognitive impairments.
The study involves clinical follow-up of patients from hospital admission to several months after completing the health education program. Validated scales will be used to measure quality of life, anxiety, and depression. The intervention will consist of health education workshops and continuous follow-up by specialized nursing staff.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education by virtual and smart-glasses | Experimental | Other: Health EducationHealth education (emotional care, mindfulness, jacobson, quality of life, social, sexual, ...). Method: psicosocial/holistic |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- Patients with digestive ostomies, either permanent or temporary ostomies lasting more than 6 months, attending ostomy consultations.
- Volunteers with permanent digestive ostomies from the Santiago and Barbanza healthcare area.
- Patients who agree to participate in the study.
Key exclusion criteria (2 listed)
- Terminal patients
- Patients with cognitive impairments
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 |
|---|---|---|
| Health EducationSession 1 (60 minutes) Patient Knowledge Assessment: Review understanding of ostomy care, including nutrition, device management, and early identification of stoma/skin complications. Feedback and Support: Address gaps in knowledge based on ostomy consultations. Skills Workshop: Build confidence and self-efficacy in daily care, reducing anxiety about complications. Session 2 (60 minutes) Mental Health and Quality of Life: Explain the link between ostomy and mental health; identify and manage anxiety/depression symptoms; promote healthy habits and social integration. Mindfulness and Stress Management: Teach breathing and relaxation techniques to manage stress and improve body acceptance. Guided Visualization: Focus on acceptance and confidence building. Action Plan: Summarize techniques and encourage regular practice. Session 3 Healthy Habits: Nutrition, exercise, rest, and stress management. Social Integration: Communication, participation, and support networks. Closing: Summary, resou | Other | Health education by virtual and smart-glasses |
Primary outcome
Beck Depression Inventory
Time frame: Baseline and at 3 months
Beck Depression Inventory
36-Item Short Form Health Survey
Time frame: Baseline and at 3 months
36-Item Short Form Health Survey
Beck anxiety inventory
Time frame: Baseline and at 3 months
Beck anxiety inventory
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 16 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education in people with Colon Cancer and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Hospital Clinico Universitario de Santiago 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: Baseline and at 3 months). 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?
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 16 Jan 2026.