Lamarche Jani, Nissim Rinat, Avery Jonathan, Wong Jiahui, Maheu Christine, Lambert Sylvie D, Laizner Andrea M, Jones Jennifer, Esplen Mary Jane, Lebel Sophie
School of Psychology, University of Ottawa, 136 Jean-Jacques-Lussier Private, Ottawa, ON, K1N 9A8, Canada.
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Pilot Feasibility Stud. 2024 Nov 19;10(1):143. doi: 10.1186/s40814-024-01567-4.
Fear of cancer recurrence (FCR) is common, persistent, and is associated with lower quality of life, impaired functioning, and psychological distress in cancer patients. Studies suggest that family caregivers of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients and in patient-caregiver dyads. However, to date, no intervention exists to individually target family caregiver's FCR. The aims of the proposed pilot study are to (1) assess the feasibility and acceptability of the newly adapted Family Caregiver-Fear Of Recurrence Therapy (FC-FORT) intervention to inform a larger randomized control trial study, and (2) estimate the clinical significance of FC-FORT. Initial evaluation of FC-FORT revealed high user satisfaction and usability.
A parallel, two-group, pilot randomized controlled trial comparing FC-FORT to a waitlist control (care as usual) will be conducted. Participant inclusion criteria are (a) women family caregivers taking care of adult cancer patients (no recurrence), (b) experiencing clinical levels of FCR, (c) access to a computer/internet connection, and (d) living in Canada. Participants (n = 36) will be recruited at Ottawa and Toronto hospitals, previous study participant pools, through social media and community partners across Canada. Participants in the intervention group will complete the FC-FORT intervention (7 consecutive weeks of virtual group therapy and homework). Participants in the control group will be offered the intervention after their participation in the study. All participants will be asked to complete questionnaire packages at baseline (T0), immediately post-intervention (7 weeks; T1) and at 3-months post-intervention (T2). Feasibility (e.g., recruitment, allocation, fidelity), acceptability (e.g., dropout, completion, satisfaction) and clinical significance of secondary outcomes will be evaluated (i.e., FCR illness uncertainty). Participants in the intervention group will be asked to complete measures of group cohesion and therapeutic alliance and take part in a semi-structured exit interview exploring their overall experience with FC-FORT.
This project will evaluate the acceptability and feasibility of the newly adapted FC-FORT to inform a larger trial.
NCT, NCT05441384. Registered July 1st, 2022, https://classic.
gov/ct2/show/NCT05441384.
癌症复发恐惧（FCR）很常见且持续存在，与癌症患者生活质量降低、功能受损及心理困扰相关。研究表明，癌症患者的家庭照顾者所经历的FCR水平与患者本人相当或更高。在过去5年中，多项干预措施已证明其能够降低癌症患者及患者 - 照顾者二元组中的FCR。然而，迄今为止，尚无针对家庭照顾者FCR的个体化干预措施。拟进行的试点研究的目的是：（1）评估新改编的家庭照顾者 - 癌症复发恐惧疗法（FC - FORT）干预措施的可行性和可接受性，以为更大规模的随机对照试验提供参考；（2）评估FC - FORT的临床意义。对FC - FORT的初步评估显示出较高的用户满意度和可用性。
将进行一项平行、两组的试点随机对照试验，比较FC - FORT与等待名单对照（照常护理）。参与者纳入标准为：（a）照顾成年癌症患者（无复发）的女性家庭照顾者；（b）经历临床水平的FCR；（c）能够使用计算机/互联网连接；（d）居住在加拿大。将在渥太华和多伦多的医院、以往的研究参与者库、通过加拿大各地的社交媒体和社区合作伙伴招募参与者（n = 36）。干预组的参与者将完成FC - FORT干预（连续7周的虚拟团体治疗和家庭作业）。对照组的参与者在参与研究后将接受该干预。所有参与者将被要求在基线（T0）、干预后立即（7周；T1）和干预后3个月（T2）完成问卷调查包。将评估可行性（如招募、分配、保真度）、可接受性（如退出、完成、满意度）以及次要结局的临床意义（即FCR、疾病不确定性）。干预组的参与者将被要求完成团体凝聚力和治疗联盟的测量，并参加一次半结构化的退出访谈，探讨他们对FC - FORT的总体体验。
本项目将评估新改编的FC - FORT的可接受性和可行性，以为更大规模的试验提供参考。
NCT，NCT05441384。于2022年7月1日注册，https://classic.
gov/ct2/show/NCT05441384。
