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OpenTrials
Completed

NCT Number: NCT02600299

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Centre Singapore

Singapore, 169610

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psychoeducation group

Behavioral

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.

Usual Care

Behavioral

Usual Care

Primary outcomes

  1. Severity of anxiety, as measured using Beck Anxiety Inventory

    Time frame: Within one month after the program

  2. Quality of life

    Time frame: Within one month after the program

Secondary outcomes

  1. Severity of cognitive dysfunction, as measured using FACT-Cog

    Time frame: Within one month after the program

  2. Severity of symptom burden, as measured using Rotterdam Symptom Checklist

    Time frame: Within one month after the program

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2015
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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