Effect of Psycho-Educational Program and Relaxation Training on Resilience Among Women With Breast Cancer

June 17, 2024 updated by: Abeer Abd Elwahed Almowafy

Effect of Psycho-Educational Program and Relaxation Training on Resilience, Self- Esteem and Psychological Distress Among Women With Breast Cancer

Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer.

Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in Assiut, Egypt. The women were randomly allocated to the intervention group and control group.

Method: Data collection took place at the outpatient clinic at the Assiut University in South Egypt Cancer Institute. The study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. Group 1 received a psychoeducational program and relaxation training, while Group 2 received only routine care without the psychoeducational program. Inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. The investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most frequent kind of cancer among women in developed as well as developing nations, and it is the leading malignancy among females in Egypt

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Nursing

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ranging from 20 to 60 years
  • Consent to research participation
  • Nonmetastatic breast cancer diagnosis

Exclusion Criteria:

  • Failing to engage regularly in the psychoeducational programme
  • Suffering from a significant illness other than breast cancer
  • Having a history of persistent psychological illnesses
  • Using psychiatric medications.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a psychoeducational program and relaxation training
Behavioral: psychoeducational
educational program
No Intervention: routine care without the psychoeducational program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer
Time Frame: 5 months
The effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer
5 months

Collaborators and Investigators

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

Sponsor

Abeer Abd Elwahed Almowafy

Investigators

  • Study Director: Saleh O Abdullah, prof, Assiut

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)

January 7, 2024

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assiut university (Other Identifier: assiut university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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