Clinical trial NCT02600299: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Cancer
Anxiety
Cognitive Dysfunction
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Severity of anxiety, as measured using Beck Anxiety Inventory
timeFrame: Within one month after the program
measure: Quality of life
timeFrame: Within one month after the program
Secondary outcomes:
measure: Severity of cognitive dysfunction, as measured using FACT-Cog
timeFrame: Within one month after the program
measure: Severity of symptom burden, as measured using Rotterdam Symptom Checklist
timeFrame: Within one month after the program
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National University of Singapore
name: Alexandre Chan, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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.