UNASSIGNED: We planned this trial using a pragmatic, non-randomised controlled design, recruiting a comparator sample from a second clinical site. The intervention was delivered over six-weekly sessions; data were collected from participants at baseline, weekly during the intervention, and at one-week and three-month follow-up. Logistical challenges meant that we only recruited 8 participants to the intervention group, and 26 participants to the control group.
UNASSIGNED: We did not find significant, between-group differences for depression, quality of life or unmet needs, though some differences at follow-up were found for anxiety ( p<.001). Analysis of potential intervention mediator processes indicated the potential importance of self-management self-efficacy. Low uptake into the psychological intervention raises questions about (a) patient-driven needs for group-based support, and (b) the sustainability of this intervention programme.
UNASSIGNED: This study failed to recruit to target; the under-powered analysis likely explains the lack of significant effects reported, though some trends in the data are of interest. Retention in the intervention group, and low attrition in the control group indicate acceptability of the intervention content and trial design; however a small baseline population rendered this trial infeasible in its current design. Further work is required to answer our research questions, but also, importantly, to address low uptake for psychological interventions in this group of cancer survivors.
UNASSIGNED: ClinicalTrials.gov, NCT03553784 (registered 14 June 2018).
An increasing number of people are surviving for longer time periods following treatment for gynaecological cancer and this means we need to change how we care for and support a growing cancer survivor population. Psychological distress and poor quality of life are common in people affected by cancer, and these do not always improve once treatment ends. Providing psychological support can be expensive, which means that not everyone who wants it can access it. Psychological Wellbeing Practitioners (PWPs) have been introduced in UK health care. This workforce might offer an alternative for providing psychological support to a greater number of cancer survivors. We aimed to test how good a PWP co-delivered intervention is at improving depression, anxiety and quality of life in people who had been treated for gynaecological cancer. The intervention was delivered to small groups of patients over six weekly sessions. We compared those who received the intervention with a similar patient group who did not have access to the same psychological support from a different hospital. Participants reported their psychological wellbeing and quality of life at the point of recruitment, weekly for six weeks, and then at follow-up time-points one week and three months later. Because of low interest in the group intervention we did not recruit to target. Only 8 participants took part in the intervention, and we recruited only 26 participants in the control group. This means we can’t have full confidence in our results. Nonetheless, the findings indicate that this intervention was helpful for improving participants’ anxiety levels. Further trials, which recruit a larger number of cancer survivors, are needed to answer our research questions. However, this trial indicates acceptability and potential benefit. We also need to undertake research to understand why so few cancer survivors wanted to take part in this group-based intervention.
■我们计划使用务实的,非随机对照设计,从第二个临床站点招募比较样本。干预措施是在六周的会议上进行的;数据是在基线时从参与者那里收集的,干预期间每周一次,以及为期一周和三个月的随访。后勤挑战意味着我们只招募了8名参与者进入干预组,和26名参与者进入对照组。
■我们没有发现显著,抑郁症的组间差异,生活质量或未满足的需求,尽管在随访中发现焦虑存在一些差异(p<.001)。对潜在干预中介过程的分析表明,自我管理自我效能感的潜在重要性。对心理干预的低吸收引发了以下问题:(a)患者驱动的对基于团体的支持的需求,和(b)这一干预方案的可持续性。
■这项研究未能招募目标;动力不足的分析可能解释了报告的缺乏重大影响,尽管数据中的一些趋势令人感兴趣。保留在干预组中,对照组的低减员表明干预内容和试验设计是可接受的;然而,基线人群较少,使得该试验在目前的设计中不可行.需要进一步的工作来回答我们的研究问题,而且,重要的是,以解决这组癌症幸存者中心理干预措施的低摄取问题。
■ClinicalTrials.gov,NCT03553784(2018年6月14日注册)。
越来越多的人在妇科癌症治疗后存活的时间更长,这意味着我们需要改变我们关心和支持不断增长的癌症幸存者群体的方式。心理困扰和生活质量差在受癌症影响的人群中很常见,一旦治疗结束,这些并不总是改善。提供心理支持可能很昂贵,这意味着不是每个想要它的人都可以访问它。在英国医疗保健中引入了心理健康从业者(PWP)。这种劳动力可能为更多的癌症幸存者提供心理支持提供替代方案。我们的目的是测试PWP共同实施的干预措施在改善抑郁症方面有多好,曾接受妇科癌症治疗的患者的焦虑和生活质量。干预措施在每周六次的会议上被提供给小组患者。我们将接受干预的患者与无法从不同医院获得相同心理支持的相似患者组进行了比较。参与者在招募时报告了他们的心理健康和生活质量,每周六周,然后在一周和三个月后的随访时间点。由于对团体干预的兴趣低,我们没有招募目标。只有8名参与者参与了干预,我们只招募了26名对照组参与者.这意味着我们不能完全相信我们的结果。尽管如此,研究结果表明,这种干预措施有助于改善参与者的焦虑水平。进一步的审判,招募了更多的癌症幸存者,需要回答我们的研究问题。然而,本试验表明可接受性和潜在获益.我们还需要进行研究,以了解为什么很少有癌症幸存者愿意参加这种基于群体的干预。