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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jul 2015
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 22, 2016
September 1, 2016
6 months
November 4, 2015
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (2)
Intervention Arm
EXPERIMENTALOn 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. This program is designed to take place on three individual days on a weekend. For each session, three major topics will be covered, with lectures and interactive workshop integrated. Sessions will be conducted by healthcare professionals who are experts/well-versed in their respective domains.
Usual Care
PLACEBO COMPARATORNo active intervention provided.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with breast cancer were included if they met the following criteria:
- 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
You may not qualify if:
- Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Centre Singapore
Singapore, 169610, Singapore
Related Publications (1)
Chan A, Gan YX, Oh SK, Ng T, Shwe M, Chan R, Ng R, Goh B, Tan YP, Fan G. A culturally adapted survivorship programme for Asian early stage breast cancer patients in Singapore: A randomized, controlled trial. Psychooncology. 2017 Oct;26(10):1654-1659. doi: 10.1002/pon.4357. Epub 2017 Jan 25.
PMID: 28024163DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Chan, PharmD
National University of Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 9, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
September 22, 2016
Record last verified: 2016-09