Women With Breast CancerNCT06470490
Effect of Psycho-Educational Program and Relaxation Training on Resilience Among Women With Breast Cancer
A study testing psychoeducational in people with Women With Breast Cancer, run by Abeer Abd Elwahed Almowafy at 1 site in Egypt.
Trial summary
Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer. Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women With Breast Cancer
- What is being tested?
- psychoeducational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2024to 2 May 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranging from 20 to 60 years
- Consent to research participation
- Nonmetastatic breast cancer diagnosis
Who cannot join
- Failing to engage regularly in the psychoeducational programme
- Suffering from a significant illness other than breast cancer
- Having a history of persistent psychological illnesses
- Using psychiatric medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Psycho-Educational Program and Relaxation Training on Resilience, Self- Esteem and Psychological Distress Among Women With Breast Cancer
Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer.
Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in Assiut, Egypt. The women were randomly allocated to the intervention group and control group.
Method: Data collection took place at the outpatient clinic at the Assiut University in South Egypt Cancer Institute. The study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. Group 1 received a psychoeducational program and relaxation training, while Group 2 received only routine care without the psychoeducational program. Inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. The investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.
Read the detailed description
Breast cancer is the most frequent kind of cancer among women in developed as well as developing nations, and it is the leading malignancy among females in Egypt
- Conditions
- Women With Breast Cancer
- Being tested
- psychoeducational
- Keywords
- Self-esteem, Psychological Distress, 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.
psychoeducationalBehavioural
educational program
| Study group | Role | What they receive |
|---|---|---|
| a psychoeducational program and relaxation training | Experimental | a psychoeducational program and relaxation training Receives: Behavioral: psychoeducational |
| routine care without the psychoeducational program | No intervention | routine care without the psychoeducational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer
The effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start7 Jan 2024
- Primary completion14 Mar 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Breast 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeer Abd Elwahed Almowafy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Abd Elwahed Almowafy, Al-Azhar University
- Investigators
- Saleh O Abdullah, prof, Study director, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470490
- Sponsor's protocol ID
- Assiut University
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psycho-Educational Program and Relaxation Training on Resilience, Self- Esteem and Psychological Distress Among Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06470490
- Acronym / sponsor ID
- Assiut University
- Conditions
- Women With Breast Cancer
- Keywords
- Self-esteem, Psychological Distress, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abeer Abd Elwahed AlmowafyUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 24 Jun 2024 (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.
Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer.
Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in Assiut, Egypt. The women were randomly allocated to the intervention group and control group.
Method: Data collection took place at the outpatient clinic at the Assiut University in South Egypt Cancer Institute. The study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. Group 1 received a psychoeducational program and relaxation training, while Group 2 received only routine care without the psychoeducational program. Inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. The investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.
Detailed description
Breast cancer is the most frequent kind of cancer among women in developed as well as developing nations, and it is the leading malignancy among females in Egypt
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a psychoeducational program and relaxation training | Experimental | Behavioral: psychoeducationala psychoeducational program and relaxation training |
| routine care without the psychoeducational program | No intervention | –routine care without the psychoeducational program |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranging from 20 to 60 years
- Consent to research participation
- Nonmetastatic breast cancer diagnosis
Key exclusion criteria (4 listed)
- Failing to engage regularly in the psychoeducational programme
- Suffering from a significant illness other than breast cancer
- Having a history of persistent psychological illnesses
- Using psychiatric medications.
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 |
|---|---|---|
| psychoeducationaleducational program | Behavioural | a psychoeducational program and relaxation training |
Primary outcome
Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer
Time frame: 5 months
The effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer
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 24 Jun 2024.
- 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.
Saleh O Abdullah, prof study director
Assiut
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 in people with Women With Breast Cancer, run by Abeer Abd Elwahed Almowafy at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 24 Jun 2024. 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 Egypt. 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?
Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer (time frame: 5 months). 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 24 Jun 2024.