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The Effect of Psychoeducation on Psychological Distress in Women with Post-Masticectomy Breast Cancer: A Randomized Controlled Trial

The Effect of Psychoeducation on Psychological Distress in Women with Post-Masticectomy Breast Cancer: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230501003
Enrollment
84
Registered
2023-05-01
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women with breast cancer post mastectomy stage 1 to 3 and low to high anxiety score Breast cancer, Post mastectomy, Psychological distress, Psychoeducation, Women mental health

Interventions

The experimental group intervention was a psychoeducational package called PERMATA, which included audiovisual psychoeducational materials and a standard of care. The audiovisual psychoeducational too
Experimental Other,No Intervention Other
Video-based psychoeducational ,Treatment as usual

Sponsors

LPPM Diponegoro University Semarang, Indonesian
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: The participants are all women with stage I to III breast cancer who are being treated and have had a mastectomy at the hospital, aged 18 to 55 years, low to high level of anxiety.

Exclusion criteria

Exclusion criteria: Patients who refuse, patients who do not proceed to the next stage, ever received previous psychoeducation, history of antidepressant Therapy: selective serotonin reuptake inhibitors (SSRI), patients who have undergone chemotherapy and radiotherapy programs as well as cognitive, psychiatric or other severe malignancies.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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 After Mastectomy Scale (BIMS) ,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). ,serotonin levels (pre assessment) and 1 to 2 weeks later (follow up assessment). ELISA test

Countries

Indonesia

Contacts

Public ContactKariadi Hospital

Kariadi Hospital Semarang

diklitkariadi@gmail.com024 841 3476

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026