The Effectiveness of Psychoeducational Intervention in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed With Breast Cancer

NCT07013422 | Completed

• 1 other identifier: cccrc-15-2022
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if psychoeducational intervention (tailored education, coping strategies, and guided disease disclosure) in a culturally appropriate format is beneficial in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed with Breast Cancer. Patients receiving the intervention will be compared to Women who received standard medical care with no added psychoeducational content.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Psychoeducational intervention; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)

  Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale consists of 7 items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety or depression.

  At baseline the time of the first chemotherapy session and at 9 months follow-up

Secondary Outcomes (1)

• Symptom burden using the Edmonton Symptom Assessment Scale (ESAS)

  At baseline the time of the first chemotherapy session and at 9 months follow-up

Study Arms (2)

Study Intervention: five individual psychoeducational sessions (60-90 minutes each) coverin

EXPERIMENTAL

Eligible participants allocated to this arm received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children. Below is a description of the topics that were discussed with the participants in each session: 1. First session: (Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation). 2. second session: (Emotional preparation for mastectomy or reconstructive surgery and post-surgical care.) 3. Third session: (Fertility, reproductive health, and strategies for managing fertility-related distress.) 4. Fourth session: (Managing psychological impact: stress, negative thoughts, and emotional burden.) 5. Fifth session: (Communication with children about the illness, including cultural and emotional aspects.)

Other: Psychoeducational support

the Control arm: Participants Received standard medical care with no added psychoeducational content

NO INTERVENTION

the Control arm: Participants Received standard medical care with no added psychoeducational content

Interventions

Psychoeducational support OTHER

Study Intervention: psychoeducational sessions, 5 sessions were given to the participants allocated to the intervention arm (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children

Study Intervention: five individual psychoeducational sessions (60-90 minutes each) coverin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: only biological females are eligible to participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Diagnosed with Stage I-III breast cancer
• Receiving chemotherapy at SQCCCRC during the study period

You may not qualify if:

• Non-Omani nationality
• Stage IV disease
• Major psychiatric or cognitive disorders, based on medical records

Sponsors & Collaborators

• Sultan Qaboos Comprehensive Cancer Center: lead

Study Sites (1)

Sultan Qaboos Comprehensive Cancer Care and Research Centre (SQCCCRC), Muscat, Oman

Muscat, Oman

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, the Intervention Group: Received five individual psychoeducational sessions (60-90 minutes each) covering health education, stress management, coping strategies, and communication with children

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: December 5, 2022
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-06

Locations

OM (1)