Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment

Phase 2

Completed

• Conditions: Breast Cancer; Cognitive Dysfunction; Cancer; Anxiety

• Registration Number: NCT02600299
• Lead Sponsor: National University of Singapore

Brief Summary

As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL.

The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients diagnosed with breast cancer were included if they met the following criteria:

  • 21 years or older
  • able to read and understand either English or Mandarin
  • diagnosis of Stages 1-3 breast cancer by a medical oncologist
  • completed adjuvant cytotoxic treatment

Exclusion Criteria

• Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of anxiety, as measured using Beck Anxiety Inventory	Within one month after the program
Quality of life	Within one month after the program

Secondary Outcome Measures

Name	Time	Method
Severity of cognitive dysfunction, as measured using FACT-Cog	Within one month after the program
Severity of symptom burden, as measured using Rotterdam Symptom Checklist	Within one month after the program

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore