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

July 19, 2023 updated by: Alexandria University

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 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"

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Bab Sharqi
      • Alexandria, Bab Sharqi, Egypt, 21526
        • Recruiting
        • El-Shatby University Hospital
        • Contact:
          • Home / Hospitals / Alexandria / El Shatby Hospital
          • Phone Number: 034861232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the intervention group
Participants in the intervention group will receive a psychoeducational intervention program
Other: a psycho educational intervention program
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.
Sham Comparator: the control group
those in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.
Other: the routine care
the routine care provided for all gynecological cancer patients in the study setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in the Quality of life of gynecological cancer patients
Time Frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
A change in the Quality of life from baseline and follow up sessions is assessed using the Arabic version of the Functional Assessment of Cancer Therapy-General (FACT-G) version 4. It includes 27 items and covers four primary QOL domains: physical wellbeing (PWB; 7 items, score range 0-28), emotional well-being (EWB; 6 items, score range 0-24), social well-being (SWB; 7 items, score range 0-28) and functional well-being (FWB; 7 items, score range 0-28). A five-point Likert scale will be used (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much), which provided four subscale scores and a total score ranging from 0 to 108, a higher score meaning a poor QOL, a lower score indicating high QOL and low effect of gynecological cancer treatment on QOL.
over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in the Anxiety and depression
Time Frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
A change in the psychological distress from baseline and follow up sessions is assessed using the Arabic version of the Hospital Anxiety and Depression Scale (HADS).There is a total of 14 items in the scale which are equally distributed into anxiety and depression subscales. Higher scores reflect greater psychological distress.
over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
A change in the Cancer-specific stress
Time Frame: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
A change in the traumatic stress reactions to cancer diagnosis and treatment from baseline and follow up sessions is assessed using The Impact of Events Scale-Revised (ӀEЅ-R).The participants will be asked to rate the frequency of these feelings or events during the previous week, using а five-point Likert scale ranging from 0 = not at all to 4 = extremely. Items will be summed for а total score that ranges from 0 to 88. The IES-R is not meant to be diagnostic. While there is no specific cut-off score, scores higher than 24 are of concern; the higher the score the greater the concern for PTSD and associated health and well-being consequences.
over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Director: faculty of medicine Alexandria university, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • psycho-educational

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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