Effect of a Psycho-educational Intervention on Psychological Outcomes of Gynecological Cancer Patients

Alexandria University

Status: Enrolling

Conditions: Psychological

Treatments: Other: the routine care; Other: a psycho educational intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT05965596

psycho-educational

Details and patient eligibility

About

This study will be conducted to optimize the quality of care rendered for gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria.As well as to assess the effect of implementing a psychoeducational intervention program among gynecological cancer women on the:

1. Quality of life with its different domains (physical, emotional, social and functional). "as a primary objective"
2. Psychological distress and cancer-specific stress. "as secondary objectives"

Full description

Cancer is a significant health problem worldwide with wide geographical variation in incidence. Additionally it has become an important item in each country's health agenda.It is a prominent cause of mortality in both economically developed and underdeveloped nations.Unfortunately, the burden is expected to grow globally due to the development and aging of the population.Gynecological cancer, which includes cancers of the cervix, ovary, uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related mortality worldwide.In Egypt, according to the Global Cancer Observatory (GLOBOCAN) 2020, approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new cases for cervical cancer and 744 women died from the disease.

Hence, this study will be carried out to develop and implement a psychoeducational intervention program among gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria and evaluate its effect in improving their psychological outcomes and quality of life.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

the intervention group

Experimental group

Description:

Participants in the intervention group will receive a psychoeducational intervention program

Treatment:

Other: a psycho educational intervention program

the control group

Sham Comparator group

Description:

those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.

Treatment:

Other: the routine care