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

• Sponsor: National University, Singapore (Other)
• Overall Status: Completed
• CT.gov ID: NCT02600299
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Cancer; Anxiety; Cognitive Dysfunction	Behavioral: Psychoeducation group; Behavioral: Usual Care	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm 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.	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.
Placebo Comparator: Usual Care No active intervention provided.	Behavioral: Usual Care; Usual Care

Outcome Measures

Primary Outcome Measures

1. Severity of anxiety, as measured using Beck Anxiety Inventory [Within one month after the program]

2. Quality of life [Within one month after the program]

Secondary Outcome Measures

1. Severity of cognitive dysfunction, as measured using FACT-Cog [Within one month after the program]

2. Severity of symptom burden, as measured using Rotterdam Symptom Checklist [Within one month after the program]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Centre Singapore	Singapore		Singapore	169610

Sponsors and Collaborators

• National University, Singapore

Investigators

• Principal Investigator: Alexandre Chan, PharmD, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandre Chan, Associate Professor, National University, Singapore
• ClinicalTrials.gov Identifier: NCT02600299
• Other Study ID Numbers: 201504-00102
• First Posted: Nov 9, 2015
• Last Update Posted: Sep 22, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Breast Neoplasms; Cognitive Dysfunction

Study Results

No Results Posted as of Sep 22, 2016