Ruane-McAteer Eimear, O'Sullivan Joe, Porter Sam, Venderbos Lionne, Prue Gillian
School of Nursing and Midwifery, Medical Biology Centre, Queen's University, 97 Lisburn Road, Belfast, BT9 7BL, Northern Ireland.
The Northern Ireland Cancer Centre (NICC), Belfast City Hospital, 51 Lisburn Road, Belfast, BT9 7AB, Northern Ireland.
BMC Cancer. 2016 Aug 2;16:586. doi: 10.1186/s12885-016-2605-6.
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.
METHODS/DESIGN: 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.
前列腺癌是全球最常见的男性癌症之一。主动监测（AS）已被开发出来，以使低风险疾病的男性能够推迟或避免与根治性治疗相关的不良副作用，直到疾病进展。尽管主动监测有医疗益处，但据报道，患有未治疗的癌症会给患者带来巨大的情感负担。
方法/设计：本研究的目的是深入了解符合条件接受主动监测的低风险前列腺癌男性的经历。本研究采用混合方法顺序解释性设计，包括两个阶段：定量研究 followed by 定性研究。第一阶段采用多点、前瞻性、纵向探索性设计。90名被诊断为低风险前列腺癌的男性将在诊断后立即（基线）进行评估，并在12个月内每隔3个月进行随访。还将通过同伴提名招募90名年龄匹配且未被诊断患有癌症的男性，并以相同的3个月间隔进行随访。在第一阶段完成后，将邀请10 - 15名报告心理功能最佳和最差的主动监测参与者参加半结构化定性访谈。第二阶段将有助于进一步探索定量结果，并更深入地了解参与者对其疾病和心理健康的个人解读。
据我们所知，这是第一项利用早期基线测量；纳入健康对照组；通过功效计算确定样本量；并采用混合方法深入全面了解被诊断为低风险前列腺癌男性经历的研究。
