title: An exploration of men's experiences of undergoing active surveillance for favourable-risk prostate cancer: A mixed methods study protocol.
abstract: Prostate cancer is one of the most common male cancers worldwide. Active Surveillance (AS) has been developed to allow men with lower risk disease to postpone or avoid the adverse side effects associated with curative treatments until the disease progresses. Despite the medical benefits of AS, it is reported that living with untreated cancer can create a significant emotional burden for patients.
  
  
  
  The aim of this study is to gain insight into the experiences of men eligible to undergo AS for favourable-risk PCa. This study has a mixed-methods sequential explanatory design consisting of two phases: quantitative followed by qualitative. Phase 1 has a multiple point, prospective, longitudinal exploratory design. Ninety men diagnosed with favourable-risk prostate cancer will be assessed immediately post-diagnosis (baseline) and followed over a period of 12 months, in intervals of 3 month. Ninety age-matched men with no cancer diagnosis will also be recruited using peer nomination and followed up in the same 3 month intervals. Following completion of Phase 1, 10-15 AS participants who have reported both the best and worst psychological functioning will be invited to participate in semi-structured qualitative interviews. Phase 2 will facilitate further exploration of the quantitative results and obtain a richer understanding of participants' personal interpretations of their illness and psychological wellbeing.
  
  
  
  To our knowledge, this is the first study to utilise early baseline measures; include a healthy comparison group; calculate sample size through power calculations; and use a mixed methods approach to gain a deeper more holistic insight into the experiences of men diagnosed with favourable-risk prostate cancer.
authors.affiliation: School of Nursing and Midwifery, Medical Biology Centre, Queen's University, 97 Lisburn Road, Belfast, BT9 7BL, Northern Ireland. eruanemcateer01@qub.ac.uk.
authors.forename: Eimear
authors.identifier: 0000-0003-1669-218X
authors.initials: E
authors.lastname: Ruane-McAteer
authors.affiliation: The Northern Ireland Cancer Centre (NICC), Belfast City Hospital, 51 Lisburn Road, Belfast, BT9 7AB, Northern Ireland.
authors.forename: Joe
authors.initials: J
authors.lastname: O'Sullivan
authors.affiliation: School of Nursing and Midwifery, Medical Biology Centre, Queen's University, 97 Lisburn Road, Belfast, BT9 7BL, Northern Ireland.
authors.forename: Sam
authors.initials: S
authors.lastname: Porter
authors.affiliation: Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Lionne
authors.initials: L
authors.lastname: Venderbos
authors.affiliation: School of Nursing and Midwifery, Medical Biology Centre, Queen's University, 97 Lisburn Road, Belfast, BT9 7BL, Northern Ireland.
authors.forename: Gillian
authors.initials: G
authors.lastname: Prue
mesh_terms: D000223:Adaptation, Psychological; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010379:Peer Group; D011159:Population Surveillance / Q000379:methods*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000523:psychology*; D011788:Quality of Life; D018401:Sample Size
keywords: Active surveillance; Anxiety; Depression; Mixed methods; Prostate cancer; Psychological adjustment; Quality of life; Uncertainty