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

NCT ID: NCT02600299

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-03-31

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.

Conditions

Breast Cancer; Cancer; Anxiety; Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychoeducation group

Intervention Type: 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

No active intervention provided.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual Care

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Usual Care

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Chan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Chan, PharmD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

National Cancer Centre Singapore

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 28024163 (View on PubMed)

Other Identifiers

201504-00102

Identifier Type: -

Identifier Source: org_study_id