NCT06470490

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 3, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

Self-esteemPsychological DistressBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    The effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer

    5 months

Study Arms (2)

a psychoeducational program and relaxation training

EXPERIMENTAL

a psychoeducational program and relaxation training

Behavioral: psychoeducational

routine care without the psychoeducational program

NO INTERVENTION

routine care without the psychoeducational program

Interventions

educational program

a psychoeducational program and relaxation training

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Asyut, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Saleh O Abdullah, prof

    Assiut

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 24, 2024

Study Start

January 7, 2024

Primary Completion

March 14, 2024

Study Completion

May 2, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations