Improving psychological outcomes for women with gynecological cancer
Effect of a Psycho-educational Intervention on Psychological Outcomes and Quality of Life Among Gynecological Cancer Patients in El-shatby University Hospital, Alexandria: Randomized Controlled Trial
This study is testing a support program for women newly diagnosed with gynecological cancer to see if it can improve their overall well-being and help them cope better during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria, Bab Sharqi) |
| Trial ID | NCT05965596 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the quality of care for women diagnosed with gynecological cancers by implementing a psychoeducational intervention program at El-Shatby University Hospital in Alexandria. The primary objective is to assess the impact of this intervention on various domains of quality of life, including physical, emotional, social, and functional aspects. Additionally, the study will evaluate secondary outcomes related to psychological distress and cancer-specific stress among participants. The intervention is designed for women who are newly diagnosed and scheduled for surgery, providing them with support during a critical time in their treatment journey.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 20 years old who have been newly diagnosed with gynecological cancers and are scheduled for surgery.
Not a fit: Patients in late-stage cancer (stage IV), those with additional cancer diagnoses, severe psychiatric disorders, or those participating in other intervention studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the psychological well-being and overall quality of life for women facing gynecological cancers.
How similar studies have performed: While psychoeducational interventions have shown promise in improving psychological outcomes in cancer patients, this specific approach targeting gynecological cancers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women are eligible to participate if they are: * Over 20 years old. * Newly diagnosed cases with gynecological cancers (confirmed within 3 months). * Scheduled to have surgery as the first-line treatment. * Willing to participate in the study. Exclusion Criteria: Women are excluded if they: * Are in the late stage (stage IV) as women in this group usually receive palliative/ symptomatic treatment. * Have additional cancer diagnosis (including metastasis). * Are diagnosed with severe psychiatric or cognitive disorder. * Participate in other intervention study.
Where this trial is running
Alexandria, Bab Sharqi
- El-Shatby University Hospital — Alexandria, Bab Sharqi, Egypt (Recruiting)
Study contacts
- Study coordinator: Fadia samir
- Email: F_shaban2008@alexmed.edu.eg
- Phone: 01273855505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.