title: Study protocol for the OPTion randomised controlled trial on the effect of prioritising treatment goals among older patients with cancer in a palliative setting.
abstract: OBJECTIVE
  Traditionally, general practitioners (GPs) are not involved in cancer-related treatment decisions, despite their often long relationship with patients, and their unique position to explore patients' values, especially with older patients. Therefore, we designed a randomised controlled trial to study the effect, on self-efficacy related to treatment decisions, of a conversation about treatment goals between GPs and patients with cancer in a palliative setting.
  
  
  METHODS
  We aim to include 168 patients aged ≥70 years with a diagnosis of non-curable cancer, due to consult their oncologist about treatment options. In the intervention group, patients will consult their GP using an Outcome Prioritisation Tool (OPT). The control group will receive care as usual. The primary outcome will be the score on a decision self-efficacy scale after the consultation with the oncologist. Secondary outcomes will be symptoms of depression, anxiety, or fatigue. In an embedded observational study of the intervention group, we aim to assess the prioritisation of treatment goals (i.e., OPT scores), and their determinants, over a six-month period.
  
  
  CONCLUSIONS
  The OPTion study should provide relevant information about the effect on self-efficacy of a consultation between GPs and older patients with cancer, concerning preferred treatment goals in a palliative setting. Dutch Trial Register NTR5419.
authors.affiliation: University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands. Electronic address: m.e.stegmann@umcg.nl.
authors.forename: M E
authors.initials: ME
authors.lastname: Stegmann
authors.affiliation: University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Schuling
authors.affiliation: University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, The Netherlands.
authors.forename: T J N
authors.initials: TJ
authors.lastname: Hiltermann
authors.affiliation: University Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands.
authors.forename: A K L
authors.initials: AK
authors.lastname: Reyners
authors.affiliation: University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Burger
authors.affiliation: University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.
authors.forename: M Y
authors.initials: MY
authors.lastname: Berger
authors.affiliation: University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.
authors.forename: A J
authors.initials: AJ
authors.lastname: Berendsen
mesh_terms: D000368:Aged; D001008:Anxiety Disorders / Q000209:etiology; D003142:Communication; D003657:Decision Making; D003866:Depressive Disorder / Q000209:etiology; D005221:Fatigue / Q000209:etiology; D058006:General Practice; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications / Q000523:psychology / Q000628:therapy*; D010166:Palliative Care; D010347:Patient Care Planning; D010358:Patient Participation; D010817:Physician-Patient Relations; D012107:Research Design; D020377:Self Efficacy
keywords: Neoplasms; Older people; Palliative care; Patient-provider communication; Self-efficacy; Shared decision making