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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

NCT02600299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Psychoeducation group

On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed. Patients in the PEG group will be involved in three sessions of psychoeducation. The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.

BEHAVIORAL

Usual Care

Usual Care

Sponsors & Collaborators

Principal Investigators

  • Alexandre Chan, PharmD · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600299 on ClinicalTrials.gov