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Trial Title:
Effect of a Psycho-educational Intervention on Psychological Outcomes of Gynecological Cancer Patients
NCT ID:
NCT05965596
Condition:
Psychological
Conditions: Keywords:
gynecological cancer
quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
a psycho educational intervention program
Description:
The program was developed by the researcher herself based on recommendations derived from
a systematic review of psychoeducational interventions to improve the quality of Life and
psychological outcomes in gynecological cancer patients. Also guided by the program
adopted by chow et all in 2014(28) to test the feasibility of implementing a
psychoeducational intervention program for gynecological cancer patients.
Arm group label:
the intervention group
Intervention type:
Other
Intervention name:
the routine care
Description:
the routine care provided for all gynecological cancer patients in the study setting
Arm group label:
the control group
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.
Criteria for 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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
El-Shatby University Hospital
Address:
City:
Alexandria
Zip:
21526
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Home / Hospitals / Alexandria / El Shatby Hospital
Phone:
034861232
Start date:
April 1, 2023
Completion date:
April 1, 2024
Lead sponsor:
Agency:
Alexandria University
Agency class:
Other
Source:
Alexandria University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965596
