Breast Cancer Female NOSEDU-INT-BCNCT07367074
Effect of an Educational Intervention in Women With Breast Cancer (EDU-INT-BC)
A study testing Therapeutic Education Program for Women With Breast Cancer in people with Breast Cancer Female NOS, run by Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco at 1 site in Morocco.
Trial summary
This study aims to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with Mohammed VI University Hospital Center in Marrakech. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female NOS
- What is being tested?
- Therapeutic Education Program for Women With Breast Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMorocco
- Study dates
- 26 Jan 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older.
- Diagnosed with breast cancer.
- Receiving oral anticancer treatment.
- Willing to participate in the study.
- Able to attend the educational sessions.
- Having access to a mobile phone (smartphone).
Who cannot join
- Women with communication disorders.
- Women with severe psychiatric disorders that will interfere with participation in the educational intervention.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Medical Oncology Department, Ibn Tofail Hospital, Mohammed VI University Hospital Center
Marrakesh, Marrakesh-Safi
About this study
Official title: Effect of an Educational Intervention on Sexual Function and Therapeutic Adherence in Women With Breast Cancer
This study aims to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with Mohammed VI University Hospital Center in Marrakech.
Participants will receive a structured therapeutic education program focusing on breast cancer, available treatments and their potential side effects, as well as treatment adherence and its prognostic significance. Educational sessions will be complemented by patient follow-up to reinforce key messages and support adherence.
The study will assess changes in sexual function and therapeutic adherence before and after the educational intervention.
Read the detailed description
This is an interventional study without a control group aiming to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with the Mohammed VI University Hospital Center (CHU) in Marrakech.
Methodology: Participants will be recruited among women aged over 18 years, diagnosed with breast cancer, receiving oral anticancer treatment, and willing to participate in the study. Sociodemographic and clinical data will be collected through interviews with the participants and by reviewing their medical records.
Intervention: The therapeutic education program will consist of two sessions conducted by a midwife experienced in breast and cervical cancer screening, enrolled in the final semester of the Master's program in Advanced Practice in Oncology and Palliative Care at ISPITS Marrakech. The sessions will address topics such as breast cancer, available treatments and their role, treatment-related effects on sexual function, as well as the importance of therapeutic adherence and behavioral coping strategies. In addition, participants will benefit from supportive follow-up through a moderated WhatsApp group designed to reinforce educational messages, facilitate experience sharing among participants, and provide ongoing support throughout the intervention period.
Evaluations: Outcomes will be assessed using validated questionnaires to evaluate sexual function and therapeutic adherence. The questionnaires will be administered before the intervention and two months after the educational intervention in order to assess changes in sexual function and therapeutic adherence among participants.
Ethical Considerations: The study will comply with all ethical principles, including obtaining informed consent and ensuring the participants' right to withdraw from the study at any time. The intervention has already received approval from the ethics committee and will also be approved by a research professor and a permanent faculty member trained in therapeutic education at ISPITS, as well as by a medical oncology professor at Mohammed VI University Hospital Center in Marrakech, prior to its implementation.
Data Analysis: Data will be analyzed using SPSS software. For variables not following a normal distribution, non-parametric statistical tests will be applied.
- Conditions
- Breast Cancer Female NOS
- Being tested
- Therapeutic Education Program for Women With Breast Cancer
- Keywords
- Breast cancer, Educational intervention, Sexual function, Therapeutic adherence
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education Program for Women With Breast CancerBehavioural
This intervention will consist of a structured therapeutic education program designed for women with breast cancer. The program will focus on disease-related information, treatment modalities and their associated side effects, sexual function, and strategies to improve therapeutic adherence. The intervention will include two face-to-face educational sessions, each lasting two hours, delivered by a midwife enrolled in the final semester of a Master's program in Advanced Practices in Oncology and Palliative Care, followed by supportive follow-up through a WhatsApp group that enables participants to share experiences, receive educational reinforcement, and discuss concerns related to treatment and sexual health. The educational content will be adapted to participants' needs and health literacy levels. Outcomes related to sexual function and treatment adherence will be assessed before the intervention and two months after its implementation.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Arm | Experimental | Participants assigned to this arm will receive a structured educational intervention focusing on breast cancer, treatment-related side effects, sexual health, and therapeutic adherence. The intervention consists of two educational sessions of two hours each, followed by follow-up support via WhatsApp. Outcomes will be assessed before the intervention and two months after its implementation. Receives: Behavioral: Therapeutic Education Program for Women With Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function Score (FSFI)
Sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated questionnaire with a total score ranging from 2 to 36, where higher scores indicate better sexual function.
The primary outcome will be the change in the total FSFI score between baseline and two months after the educational intervention.
Measured: Baseline and 2 months after the intervention
Secondary outcomes (1)
Change in Therapeutic Adherence Score (ARMS-12)
Therapeutic adherence will be assessed using the Adherence to Refills and Medications Scale (ARMS-12), a validated questionnaire with a total score ranging from 12 to 48, where lower scores indicate better medication adherence.
The secondary outcome will be the change in the total ARMS-12 score between baseline and two months after the educational intervention.
Measured: Baseline and 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start26 Jan 2026
- Primary completion24 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Female NOSStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group interventional study with a pre-post design, in which all participants receive the same educational intervention.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAAMARI Safa, Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367074
- Sponsor's protocol ID
- ISPITS-PAOSP-EDU-INT-BC-2025
- Acronym
- EDU-INT-BC
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Intervention on Sexual Function and Therapeutic Adherence in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07367074
- Acronym / sponsor ID
- EDU-INT-BC / ISPITS-PAOSP-EDU-INT-BC-2025
- Conditions
- Breast Cancer Female NOS
- Keywords
- Breast cancer, Educational intervention, Sexual function, Therapeutic adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituts Supérieurs des Professions Infirmières et Techniques de Santé, MoroccoUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 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.
This study aims to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with Mohammed VI University Hospital Center in Marrakech.
Participants will receive a structured therapeutic education program focusing on breast cancer, available treatments and their potential side effects, as well as treatment adherence and its prognostic significance. Educational sessions will be complemented by patient follow-up to reinforce key messages and support adherence.
The study will assess changes in sexual function and therapeutic adherence before and after the educational intervention.
Detailed description
This is an interventional study without a control group aiming to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with the Mohammed VI University Hospital Center (CHU) in Marrakech.
Methodology: Participants will be recruited among women aged over 18 years, diagnosed with breast cancer, receiving oral anticancer treatment, and willing to participate in the study. Sociodemographic and clinical data will be collected through interviews with the participants and by reviewing their medical records.
Intervention: The therapeutic education program will consist of two sessions conducted by a midwife experienced in breast and cervical cancer screening, enrolled in the final semester of the Master's program in Advanced Practice in Oncology and Palliative Care at ISPITS Marrakech. The sessions will address topics such as breast cancer, available treatments and their role, treatment-related effects on sexual function, as well as the importance of therapeutic adherence and behavioral coping strategies. In addition, participants will benefit from supportive follow-up through a moderated WhatsApp group designed to reinforce educational messages, facilitate experience sharing among participants, and provide ongoing support throughout the intervention period.
Evaluations: Outcomes will be assessed using validated questionnaires to evaluate sexual function and therapeutic adherence. The questionnaires will be administered before the intervention and two months after the educational intervention in order to assess changes in sexual function and therapeutic adherence among participants.
Ethical Considerations: The study will comply with all ethical principles, including obtaining informed consent and ensuring the participants' right to withdraw from the study at any time. The intervention has already received approval from the ethics committee and will also be approved by a research professor and a permanent faculty member trained in therapeutic education at ISPITS, as well as by a medical oncology professor at Mohammed VI University Hospital Center in Marrakech, prior to its implementation.
Data Analysis: Data will be analyzed using SPSS software. For variables not following a normal distribution, non-parametric statistical tests will be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group interventional study with a pre-post design, in which all participants receive the same educational intervention.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Arm | Experimental | Behavioral: Therapeutic Education Program for Women With Breast CancerParticipants assigned to this arm will receive a structured educational intervention focusing on breast cancer, treatment-related side effects, sexual health, and therapeutic adherence. The intervention consists of two educational sessions of two hours each, followed by follow-up support via WhatsApp. Outcomes will be assessed before the intervention and two months after its implementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 years and older.
- Diagnosed with breast cancer.
- Receiving oral anticancer treatment.
- Willing to participate in the study.
- Able to attend the educational sessions.
Key exclusion criteria (2 listed)
- Women with communication disorders.
- Women with severe psychiatric disorders that will interfere with participation in the educational intervention.
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 |
|---|---|---|
| Therapeutic Education Program for Women With Breast CancerThis intervention will consist of a structured therapeutic education program designed for women with breast cancer. The program will focus on disease-related information, treatment modalities and their associated side effects, sexual function, and strategies to improve therapeutic adherence. The intervention will include two face-to-face educational sessions, each lasting two hours, delivered by a midwife enrolled in the final semester of a Master's program in Advanced Practices in Oncology and Palliative Care, followed by supportive follow-up through a WhatsApp group that enables participants to share experiences, receive educational reinforcement, and discuss concerns related to treatment and sexual health. The educational content will be adapted to participants' needs and health literacy levels. Outcomes related to sexual function and treatment adherence will be assessed before the intervention and two months after its implementation. | Behavioural | Educational Intervention Arm |
Primary outcome
Change in Sexual Function Score (FSFI)
Time frame: Baseline and 2 months after the intervention
Sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated questionnaire with a total score ranging from 2 to 36, where higher scores indicate better sexual function. The primary outcome will be the change in the total FSFI score between baseline and two months after the educational intervention.
1 secondary outcome
Change in Therapeutic Adherence Score (ARMS-12)
Time frame: Baseline and 2 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- 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. This study is not recruiting at the moment.
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 Therapeutic Education Program for Women With Breast Cancer in people with Breast Cancer Female NOS, run by Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco at 1 site in Morocco.
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 6 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: finished, as of the sponsor's last update on 10 Jun 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 Morocco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Sexual Function Score (FSFI) (time frame: Baseline and 2 months after the intervention). 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 10 Jun 2026.