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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

Primary Purpose

Breast Cancer, Cancer, Anxiety

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Psychoeducation group
Usual Care
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Arm

Usual Care

Arm Description

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. 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.

No active intervention provided.

Outcomes

Primary Outcome Measures

Severity of anxiety, as measured using Beck Anxiety Inventory
Quality of life

Secondary Outcome Measures

Severity of cognitive dysfunction, as measured using FACT-Cog
Severity of symptom burden, as measured using Rotterdam Symptom Checklist

Full Information

First Posted
November 4, 2015
Last Updated
September 20, 2016
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02600299
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer, Anxiety, Cognitive Dysfunction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
No active intervention provided.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Severity of anxiety, as measured using Beck Anxiety Inventory
Time Frame
Within one month after the program
Title
Quality of life
Time Frame
Within one month after the program
Secondary Outcome Measure Information:
Title
Severity of cognitive dysfunction, as measured using FACT-Cog
Time Frame
Within one month after the program
Title
Severity of symptom burden, as measured using Rotterdam Symptom Checklist
Time Frame
Within one month after the program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Chan, PharmD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
28024163
Citation
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.
Results Reference
derived

Learn more about this trial

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

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