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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600299
• Other study ID #: 201504-00102
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2015
• Last updated: September 20, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Cancer
• Cognitive Dysfunction

Intervention

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.
• Usual Care
Usual Care

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of anxiety, as measured using Beck Anxiety Inventory		Within one month after the program	No
Primary	Quality of life		Within one month after the program	No
Secondary	Severity of cognitive dysfunction, as measured using FACT-Cog		Within one month after the program	No
Secondary	Severity of symptom burden, as measured using Rotterdam Symptom Checklist		Within one month after the program	No