PDF(Pubmed)
Abstract：
BACKGROUND: Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.
METHODS: PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
CONCLUSIONS: We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
BACKGROUND: ISRCTN: 13,709,798; 15-Oct-2021.
METHODS: PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
CONCLUSIONS: We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
BACKGROUND: ISRCTN: 13,709,798; 15-Oct-2021.
摘要：
背景：大约40%的头颈癌（HNC）患者出现复发。复发的风险随着治疗时间的推移而下降。目前的指南建议在治疗后的头两年每两个月进行一次临床随访，在未来三年内降低强度。然而,缺乏这些方案在检测复发方面的有效性的证据，呼吁更灵活，以患者为中心的随访策略。
方法：PETNECK2是一个基于英国的多中心计划，研究了一种新的后续行动范式，使用正电子发射断层扫描-计算机断层扫描（PET-CT）引导，基于症状，患者开始监测。这种范式正在无盲测试中，非自卑，第三阶段,随机对照试验（RCT）。HNC患者,完成治愈意向治疗一年后，在没有局部区域或远处转移的临床症状或体征的情况下，将使用1：1的分配比例随机分配给定期定期随访，或者在PET-CT引导下，患者开始随访。复发风险较低（PET-CT阴性）的患者将接受面对面的教育课程以及信息和支持（I＆S）资源包，以监测症状并在需要时控制开始紧急预约。RCT的主要结果是总生存率。RCT还有一个内置的飞行员，嵌套的QuinteT招聘干预(QRI)，以及对患者体验和对癌症复发（FCR）的恐惧的嵌套混合方法研究。最初，单臂可行性研究已经完成，确定了患者发起的监测干预的可接受性，基线问卷的完成率，并在RCT中实施之前优化了I&S资源。
结论：我们假设，将治疗后12个月的PET-CT扫描和I&S资源结合起来，既可以识别无症状复发的患者，也可以识别未来复发风险较低的患者，当怀疑复发时，他们将有权监测他们的症状并寻求早期临床随访。这种以患者为中心的护理模式的改变可能会影响生活质量和对癌症复发的恐惧。
背景：ISRCTN：13,709,798；2021年10月15日。
方法：PETNECK2是一个基于英国的多中心计划，研究了一种新的后续行动范式，使用正电子发射断层扫描-计算机断层扫描（PET-CT）引导，基于症状，患者开始监测。这种范式正在无盲测试中，非自卑，第三阶段,随机对照试验（RCT）。HNC患者,完成治愈意向治疗一年后，在没有局部区域或远处转移的临床症状或体征的情况下，将使用1：1的分配比例随机分配给定期定期随访，或者在PET-CT引导下，患者开始随访。复发风险较低（PET-CT阴性）的患者将接受面对面的教育课程以及信息和支持（I＆S）资源包，以监测症状并在需要时控制开始紧急预约。RCT的主要结果是总生存率。RCT还有一个内置的飞行员，嵌套的QuinteT招聘干预(QRI)，以及对患者体验和对癌症复发（FCR）的恐惧的嵌套混合方法研究。最初，单臂可行性研究已经完成，确定了患者发起的监测干预的可接受性，基线问卷的完成率，并在RCT中实施之前优化了I&S资源。
结论：我们假设，将治疗后12个月的PET-CT扫描和I&S资源结合起来，既可以识别无症状复发的患者，也可以识别未来复发风险较低的患者，当怀疑复发时，他们将有权监测他们的症状并寻求早期临床随访。这种以患者为中心的护理模式的改变可能会影响生活质量和对癌症复发的恐惧。
背景：ISRCTN：13,709,798；2021年10月15日。
