Clinical trial NCT05965596: Effect of a Psycho-educational Intervention on Psychological Outcomes of Gynecological Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological
Keywords: gynecological cancer
quality of life
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomly selected sample of gynecological cancer women attending the study setting, fulfilling the inclusion criteria and consented to participate in the study will be recruited into the study sample. Then they will be randomly assigned into either the intervention group or the control group using computer-generated random codes in serially numbered opaque sealed envelopes. Creation and concealment of the allocation sequence will be done by the supervisor. While the researcher will enroll the participants, assess eligibility, discuss the trial, obtain consent, ascertain intervention assignment (such as opening next envelope) and carry out the intervention. Participants in the intervention group will receive a psycho educational intervention program and those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.
Primary purpose: PREVENTION

Brief summary: 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"

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: A change in the Quality of life of gynecological cancer patients
timeFrame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
Secondary outcomes:
measure: A change in the Anxiety and depression
timeFrame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
measure: A change in the Cancer-specific stress
timeFrame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: El-Shatby University Hospital
state: Bab Sharqi
Study officials:
affiliation: Alexandria University
name: faculty of medicine Alexandria university
role: STUDY_DIRECTOR
References:
citation: Chow KM, Chan JC, Choi KK, Chan CW. A Review of Psychoeducational Interventions to Improve Sexual Functioning, Quality of Life, and Psychological Outcomes in Gynecological Cancer Patients. Cancer Nurs. 2016 Jan-Feb;39(1):20-31. doi: 10.1097/NCC.0000000000000234.
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citation: Weaver KE, Forsythe LP, Reeve BB, Alfano CM, Rodriguez JL, Sabatino SA, Hawkins NA, Rowland JH. Mental and physical health-related quality of life among U.S. cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Nov;21(11):2108-17. doi: 10.1158/1055-9965.EPI-12-0740. Epub 2012 Oct 30.