title: A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol.
abstract: BACKGROUND
  Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care.
  
  
  METHODS
  Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention.
  
  
  BACKGROUND
  This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the psychosocial concerns of caregivers, as well as for researchers seeking to refine the structure and evaluate the effectiveness of such programmes.
  
  
  BACKGROUND
  Current Controlled Trials NCT02120183 (https://clinicaltrials.gov/show/NCT02120183).
authors.affiliation: Department of Psychological Medicine, National University Hospital, Singapore Department of Psychological Medicine, National University of Singapore, Singapore Duke-NUS Graduate Medical School, Singapore, Singapore.
authors.forename: Rathi
authors.initials: R
authors.lastname: Mahendran
authors.affiliation: Department of Psychological Medicine, National University of Singapore, Singapore.
authors.forename: Joyce Yi Siang
authors.initials: JY
authors.lastname: Tan
authors.affiliation: Department of Psychology, National University of Singapore, Singapore.
authors.forename: Konstadina
authors.initials: K
authors.lastname: Griva
authors.affiliation: Department of Psychological Medicine, National University of Singapore, Singapore Duke-NUS Graduate Medical School, Singapore, Singapore.
authors.forename: Haikel Asyraf
authors.identifier: http://orcid.org/0000-0002-9529-3517
authors.initials: HA
authors.lastname: Lim
authors.affiliation: Department of Psychological Medicine, National University Hospital, Singapore.
authors.forename: Hui Ying
authors.initials: HY
authors.lastname: Ng
authors.affiliation: Department of Psychological Medicine, National University Hospital, Singapore.
authors.forename: Joanne
authors.initials: J
authors.lastname: Chua
authors.affiliation: National University Cancer Institute, Singapore, National University Health System, Singapore.
authors.forename: Siew Eng
authors.identifier: http://orcid.org/0000-0002-9529-3517
authors.initials: SE
authors.lastname: Lim
authors.affiliation: Department of Psychological Medicine, National University Hospital, Singapore Department of Psychological Medicine, National University of Singapore, Singapore.
authors.forename: Ee Heok
authors.initials: EH
authors.lastname: Kua
mesh_terms: D000328:Adult; D000368:Aged; D017028:Caregivers / Q000523:psychology*; D003863:Depression / Q000175:diagnosis* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms; D010045:Outpatients; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011615:Psychotherapy, Group; D011788:Quality of Life; D012107:Research Design; D020377:Self Efficacy; D012846:Singapore; D013315:Stress, Psychological / Q000175:diagnosis* / Q000628:therapy*; D055815:Young Adult
keywords: MENTAL HEALTH; ONCOLOGY; PSYCHIATRY; QUALITATIVE RESEARCH