The Effect Psychoeducation Material to Psychological Distress and Serotonin Levels in Indonesian Women with Breast Cancer Post Mastectomy

Phase 2

Recruiting

• Conditions: women with breast cancer post mastectomy stage 1 to 3 and low to high anxiety score; Breast cancer post mastectomy, indonesian, psychoeducation, psychological distress, randomized controlled trial, serotonin.

• Registration Number: TCTR20230501003
• Lead Sponsor: PPM Diponegoro University Semarang, Indonesian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1. women with post mastectomy breast cancer, 2. stadium 1sampai 3, 3. age 18 sampai 49 years, 4. an adequate command of the Indonesian language, and 5. low and high anxiety score

Exclusion Criteria

1. have received psychoeducation before, 2. history of antidepressant therapy: selective serotonin reuptake inhibitors (SSRIs), 3. patients who have been on chemotherapy and radiotherapy programs and cognitive, and 4. psychiatric or other serious malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological distress (pre assessment), 3 to 5 days later (post-assessment 1), and 1 to 2 weeks later (follow up assessment). Hospital anxiety and depression scale (HADS) questionarre,Serotonin levels (pre assessment) and 1 to 2 weeks later (follow up assessment). ELISA test

Secondary Outcome Measures

Name	Time	Method
Pain levels (pre assessment), 3 to 5 days later (post-assessment 1), and 1 to 2 weeks later (follow up assessment) the Numeric Rating Scale (NRS) for pain intensity ,Body image (pre assessment), 3 to 5 days later (post-assessment 1), and 1 to 2 weeks later (follow up assessment) Body Image Scale (BIS) ,Fatigue (pre assessment), 3 to 5 days later (post-assessment 1), and 1 to 2 weeks later (follow up assessment) Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F).