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

NCT ID: NCT05965596

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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

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Psychological

Keywords

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gynecological cancer quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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the intervention group

Participants in the intervention group will receive a psychoeducational intervention program

Group Type EXPERIMENTAL

a psycho educational intervention program

Intervention Type OTHER

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 control group

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

Group Type SHAM_COMPARATOR

the routine care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

the routine care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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faculty of medicine Alexandria university

Role: STUDY_DIRECTOR

Alexandria University

Locations

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El-Shatby University Hospital

Alexandria, Bab Sharqi, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fadia samir

Role: CONTACT

Phone: 01273855505

Email: [email protected]

Eman Darwish

Role: CONTACT

Phone: 01554967573

Email: [email protected]

Facility Contacts

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Home / Hospitals / Alexandria / El Shatby Hospital

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25730595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17367316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2331691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18568975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23112268 (View on PubMed)

Other Identifiers

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psycho-educational

Identifier Type: -

Identifier Source: org_study_id