Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07013422
The Effectiveness of Psychoeducational Intervention in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed With Breast Cancer
A study testing Psychoeducational support in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Sultan Qaboos Comprehensive Cancer Center at 1 site in Oman.
Trial summary
The goal of this clinical trial is to learn if psychoeducational intervention (tailored education, coping strategies, and guided disease disclosure) in a culturally appropriate format is beneficial in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed with Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Psychoeducational support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteOman
- Study dates
- 5 Dec 2022to 18 Apr 2024
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Diagnosed with Stage I-III breast cancer
- Receiving chemotherapy at SQCCCRC during the study period
Who cannot join
- Non-Omani nationality
- Stage IV disease
- Major psychiatric or cognitive disorders, based on medical records
Trial locations and contacts
1 site in 1 country.
Oman1 site
Sultan Qaboos Comprehensive Cancer Care and Research Centre (SQCCCRC), Muscat, Oman
Muscat
About this study
The goal of this clinical trial is to learn if psychoeducational intervention (tailored education, coping strategies, and guided disease disclosure) in a culturally appropriate format is beneficial in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed with Breast Cancer. Patients receiving the intervention will be compared to Women who received standard medical care with no added psychoeducational content.
Read the detailed description
Eligible participants were identified through the hospital's Health Information System (HIS).
Screening was conducted by the principal researcher in collaboration with a senior oncology nurse and was based on pre-established inclusion and exclusion criteria. This included reviewing the patients' diagnosis, cancer stage, psychiatric and cognitive status, and demographic characteristics.
Patients who met the criteria were approached during their chemotherapy sessions in private treatment rooms. An information sheet was provided, the purpose of the study was explained verbally in Arabic and written informed consent was obtained. Baseline assessments (Hospital Anxiety and Depression Scale (HADS) and Edmonton Symptom Assessment Scale (ESAS)) were administered immediately after consent during the same visit.
- Structure and Content of the Intervention:
- First session: duration 30-40 minutes Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation). 2nd session: 30-40 minutes Emotional preparation for mastectomy or reconstructive surgery and post-surgical care. 3rd session: 30-40 minutes Fertility, reproductive health, and strategies for managing fertility-related distress. 4th session : 30-40 minutes Managing psychological impact: stress, negative thoughts, and emotional burden. 5th session: 30-40 minutes Communication with children about the illness, including cultural and emotional aspects.
Delivery Technique of the Intervention:
The delivery of the psychoeducational intervention adhered to a structured yet adaptable approach, carefully aligned with the clinical routines of the daycare chemotherapy unit and the individual needs of each participant. At the beginning of each working day, the researcher accessed the hospital's Health Information System (HIS) to review the list of patients scheduled for chemotherapy. Participants in the intervention group were identified and matched against a pre-maintained tracking table documenting the session number and completion date for each participant. This system enabled the researcher to ascertain which individuals were due for a session and to plan the timing, accordingly, ensuring alignment with the patients' treatment schedules and physical conditions. Sessions were conducted individually in the private treatment rooms designated for chemotherapy administration. These rooms provided a quiet and comfortable environment conducive to privacy and uninterrupted engagement. The scheduling of each session was organized to avoid interference with medical care and to accommodate each participant's level of alertness and energy. Upon entering the room, the researcher greeted the participant with warmth and respect, briefly assessed their physical state, and began with an open-ended emotional and clinical check-in. This process involved inquiring about the participant's feelings since the last session, any emerging or worsening side effects, and whether they had reflected upon or applied any of the previously discussed topics. These follow-up conversations facilitated continuity between sessions and permitted the researcher to adapt the day's content based on the participant's current condition. The sessions were delivered verbally in Arabic, utilizing a conversational and empathetic tone. No printed handouts or written materials were provided to the participants. The researcher explained each topic using clear, accessible language, frequently pausing to check for understanding or emotional responses. Participants were encouraged to pose questions or share their thoughts, but were never pressured to engage if they preferred to remain silent.
The atmosphere was intentionally designed to be supportive, respectful, and emotionally safe.
Each session adhered to a thematic structure based on the intervention protocol, but the delivery remained flexible, contingent upon the participant's level of engagement and energy.
Some participants completed one session per week; others required longer intervals due to fatigue, low immunity, or interruptions in treatment. In certain cases, sessions were spaced up to three weeks apart. This flexibility allowed each participant to engage at her own pace without feeling overwhelmed. Subsequent to each session, the researcher documented the date, session number, approximate duration, and a brief summary of the participant's response. Observations regarding emotional readiness, questions raised, and any challenges encountered were also recorded. These records were reviewed during periodic supervision sessions with the consultant psychiatrist, who provided oversight and guidance for managing sensitive emotional content or complex patient reactions. If at any point the researcher noted that a participant was experiencing psychological distress beyond the intervention's scope-for instance, persistent sadness, anxiety, or observable signs of emotional dysregulation-the participant was promptly referred to a qualified psychiatrist or psychologist at the center for specialized support. All referrals were conducted discreetly, with full respect for the participant's privacy and comfort. This delivery technique facilitated the intervention's maintenance of both fidelity and flexibility-ensuring that core content was delivered consistently while adapting to the personal, emotional, and medical realities of each participant.
- Being tested
- Psychoeducational support
- Keywords
- Psychoeducational intervention, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational supportOther
Study Intervention: psychoeducational sessions, 5 sessions were given to the participants allocated to the intervention arm (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention: five individual psychoeducational sessions (60-90 minutes each) coverin | Experimental | Eligible participants allocated to this arm received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children. Below is a description of the topics that were discussed with the participants in each session:
1. First session: (Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation).
2. second session: (Emotional preparation for mastectomy or reconstructive surgery and post-surgical care.)
3. Third session: (Fertility, reproductive health, and strategies for managing fertility-related distress.)
4. Fourth session: (Managing psychological impact: stress, negative thoughts, and emotional burden.)
5. Fifth session: (Communication with children about the illness, including cultural and emotional aspects.) Receives: Other: Psychoeducational support |
| the Control arm: Participants Received standard medical care with no added psychoeducational content | No intervention | the Control arm: Participants Received standard medical care with no added psychoeducational content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).
Each subscale consists of 7 items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety or depression.
Measured: At baseline the time of the first chemotherapy session and at 9 months follow-up
Secondary outcomes (1)
Symptom burden using the Edmonton Symptom Assessment Scale (ESAS)
Symptom burden using the Edmonton Symptom Assessment Scale (ESAS) Symptom burden measured using the Edmonton Symptom Assessment Scale (ESAS).
Each symptom is rated on a scale from 0 (no symptom) to 10 (worst severity), with total scores ranging from 0 to 90. Higher scores indicate greater symptom burden.
Measured: At baseline the time of the first chemotherapy session and at 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start5 Dec 2022
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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
- Model description
- Randomized controlled trial, the Intervention Group: Received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013422
- Sponsor's protocol ID
- cccrc-15-2022
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Psychoeducational Intervention in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed With Breast Cancer
- ClinicalTrials.gov ID
- NCT07013422
- Acronym / sponsor ID
- cccrc-15-2022
- Keywords
- Psychoeducational intervention, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sultan Qaboos Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 10 Jun 2025 (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 goal of this clinical trial is to learn if psychoeducational intervention (tailored education, coping strategies, and guided disease disclosure) in a culturally appropriate format is beneficial in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed with Breast Cancer. Patients receiving the intervention will be compared to Women who received standard medical care with no added psychoeducational content.
Detailed description
Eligible participants were identified through the hospital's Health Information System (HIS).
Screening was conducted by the principal researcher in collaboration with a senior oncology nurse and was based on pre-established inclusion and exclusion criteria. This included reviewing the patients' diagnosis, cancer stage, psychiatric and cognitive status, and demographic characteristics.
Patients who met the criteria were approached during their chemotherapy sessions in private treatment rooms. An information sheet was provided, the purpose of the study was explained verbally in Arabic and written informed consent was obtained. Baseline assessments (Hospital Anxiety and Depression Scale (HADS) and Edmonton Symptom Assessment Scale (ESAS)) were administered immediately after consent during the same visit.
- Structure and Content of the Intervention:
- First session: duration 30-40 minutes Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation). 2nd session: 30-40 minutes Emotional preparation for mastectomy or reconstructive surgery and post-surgical care. 3rd session: 30-40 minutes Fertility, reproductive health, and strategies for managing fertility-related distress. 4th session : 30-40 minutes Managing psychological impact: stress, negative thoughts, and emotional burden. 5th session: 30-40 minutes Communication with children about the illness, including cultural and emotional aspects.
Delivery Technique of the Intervention:
The delivery of the psychoeducational intervention adhered to a structured yet adaptable approach, carefully aligned with the clinical routines of the daycare chemotherapy unit and the individual needs of each participant. At the beginning of each working day, the researcher accessed the hospital's Health Information System (HIS) to review the list of patients scheduled for chemotherapy. Participants in the intervention group were identified and matched against a pre-maintained tracking table documenting the session number and completion date for each participant. This system enabled the researcher to ascertain which individuals were due for a session and to plan the timing, accordingly, ensuring alignment with the patients' treatment schedules and physical conditions. Sessions were conducted individually in the private treatment rooms designated for chemotherapy administration. These rooms provided a quiet and comfortable environment conducive to privacy and uninterrupted engagement. The scheduling of each session was organized to avoid interference with medical care and to accommodate each participant's level of alertness and energy. Upon entering the room, the researcher greeted the participant with warmth and respect, briefly assessed their physical state, and began with an open-ended emotional and clinical check-in. This process involved inquiring about the participant's feelings since the last session, any emerging or worsening side effects, and whether they had reflected upon or applied any of the previously discussed topics. These follow-up conversations facilitated continuity between sessions and permitted the researcher to adapt the day's content based on the participant's current condition. The sessions were delivered verbally in Arabic, utilizing a conversational and empathetic tone. No printed handouts or written materials were provided to the participants. The researcher explained each topic using clear, accessible language, frequently pausing to check for understanding or emotional responses. Participants were encouraged to pose questions or share their thoughts, but were never pressured to engage if they preferred to remain silent.
The atmosphere was intentionally designed to be supportive, respectful, and emotionally safe.
Each session adhered to a thematic structure based on the intervention protocol, but the delivery remained flexible, contingent upon the participant's level of engagement and energy.
Some participants completed one session per week; others required longer intervals due to fatigue, low immunity, or interruptions in treatment. In certain cases, sessions were spaced up to three weeks apart. This flexibility allowed each participant to engage at her own pace without feeling overwhelmed. Subsequent to each session, the researcher documented the date, session number, approximate duration, and a brief summary of the participant's response. Observations regarding emotional readiness, questions raised, and any challenges encountered were also recorded. These records were reviewed during periodic supervision sessions with the consultant psychiatrist, who provided oversight and guidance for managing sensitive emotional content or complex patient reactions. If at any point the researcher noted that a participant was experiencing psychological distress beyond the intervention's scope-for instance, persistent sadness, anxiety, or observable signs of emotional dysregulation-the participant was promptly referred to a qualified psychiatrist or psychologist at the center for specialized support. All referrals were conducted discreetly, with full respect for the participant's privacy and comfort. This delivery technique facilitated the intervention's maintenance of both fidelity and flexibility-ensuring that core content was delivered consistently while adapting to the personal, emotional, and medical realities of each participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, the Intervention Group: Received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children
| Arm | Type | Receives |
|---|---|---|
| Study Intervention: five individual psychoeducational sessions (60-90 minutes each) coverin | Experimental | Other: Psychoeducational supportEligible participants allocated to this arm received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children. Below is a description of the topics that were discussed with the participants in each session: 1. First session: (Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation). 2. second session: (Emotional preparation for mastectomy or reconstructive surgery and post-surgical care.) 3. Third session: (Fertility, reproductive health, and strategies for managing fertility-related distress.) 4. Fourth session: (Managing psychological impact: stress, negative thoughts, and emotional burden.) 5. Fifth session: (Communication with children about the illness, including cultural and emotional aspects.) |
| the Control arm: Participants Received standard medical care with no added psychoeducational content | No intervention | –the Control arm: Participants Received standard medical care with no added psychoeducational content |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years
- Diagnosed with Stage I-III breast cancer
- Receiving chemotherapy at SQCCCRC during the study period
Key exclusion criteria (3 listed)
- Non-Omani nationality
- Stage IV disease
- Major psychiatric or cognitive disorders, based on medical records
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 |
|---|---|---|
| Psychoeducational supportStudy Intervention: psychoeducational sessions, 5 sessions were given to the participants allocated to the intervention arm (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children | Other | Study Intervention: five individual psychoeducational sessions (60-90 minutes each) coverin |
Primary outcome
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline the time of the first chemotherapy session and at 9 months follow-up
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale consists of 7 items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety or depression.
1 secondary outcome
Symptom burden using the Edmonton Symptom Assessment Scale (ESAS)
Time frame: At baseline the time of the first chemotherapy session and at 9 months follow-up
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 31 Jul 2025.
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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 Psychoeducational support in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Sultan Qaboos Comprehensive Cancer Center at 1 site in Oman.
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 3 inclusion and 3 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 31 Jul 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 Oman. 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?
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) (time frame: At baseline the time of the first chemotherapy session and at 9 months follow-up). 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 31 Jul 2025.