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PsychologicalNCT05965596

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

A study testing a psycho educational intervention program and the routine care in people with Psychological, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Psychological
What is being tested?
a psycho educational intervention program and the routine care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Apr 2023to 1 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Fadia samir contact

01273855505

F_shaban2008@alexmed.edu.eg

Eman Darwish contact

01554967573

emandarwish09@yahoo.com

Egypt1 site, 1 recruiting

  • El-Shatby University Hospital

    Alexandria, Bab Sharqi, 21526

    Home / Hospitals / Alexandria / El Shatby Hospital, 034861232

    Recruiting

Other trials in Egypt

About this study

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

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"
Read the 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.

Conditions
Psychological
Being tested
a psycho educational intervention program, the routine care
Keywords
gynecological cancer, quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a psycho educational intervention programOther

    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.

  • the routine careOther

    the routine care provided for all gynecological cancer patients in the study setting

Study groups in NCT05965596
Study groupRoleWhat they receive
the intervention groupExperimentalParticipants in the intervention group will receive a psychoeducational intervention program
Receives: Other: a psycho educational intervention program
the control groupSham comparatorthose in the control group will receive the routine care provided for all gynecological cancer patients in the study setting.
Receives: Other: the routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change in the Quality of life of gynecological cancer patients

    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.

    Measured: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation

Secondary outcomes (2)

  1. A change in the Anxiety and depression

    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.

    Measured: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation

  2. A change in the Cancer-specific stress

    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.

    Measured: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05965596
Sponsor's protocol ID
psycho-educational
Status last verified
Jul 2023
First submitted
11 Jul 2023
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25730595

  • Tangjitgamol S, Manusirivithaya S, Hanprasertpong J, Kasemsarn P, Soonthornthum T, Leelahakorn S, Thawaramara T, Lapcharoen O. Sexual dysfunction in Thai women with early-stage cervical cancer after radical hysterectomy. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):1104-12. doi: 10.1111/j.1525-1438.2007.00907.x. Epub 2007 Mar 15.

    PubMed 17367316

  • Padilla GV, Ferrell B, Grant MM, Rhiner M. Defining the content domain of quality of life for cancer patients with pain. Cancer Nurs. 1990 Apr;13(2):108-15.

    PubMed 2331691

  • Lim JW, Yi J, Zebrack B. Acculturation, social support, and quality of life for Korean immigrant breast and gynecological cancer survivors. Ethn Health. 2008 Jun;13(3):243-60. doi: 10.1080/13557850802009488.

    PubMed 18568975

  • 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.

    PubMed 23112268

Questions about this trial

What is this clinical trial studying?

A study testing a psycho educational intervention program and the routine care in people with Psychological, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fadia samir (01273855505, F_shaban2008@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05965596, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.

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