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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Singapore, Singapore, 169610
- National Cancer Centre Singapore
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
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Placebo-jämförare: Usual Care
No active intervention provided.
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Vanlig vård
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Severity of anxiety, as measured using Beck Anxiety Inventory
Tidsram: Within one month after the program
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Within one month after the program
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Quality of life
Tidsram: Within one month after the program
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Within one month after the program
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Severity of cognitive dysfunction, as measured using FACT-Cog
Tidsram: Within one month after the program
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Within one month after the program
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Severity of symptom burden, as measured using Rotterdam Symptom Checklist
Tidsram: Within one month after the program
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Within one month after the program
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alexandre Chan, PharmD, National University of Singapore
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201504-00102
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