Department of Psychology, University of Colorado Denver, Denver, CO, USA.
Lombardi Comprehensive Cancer Center, Cancer Prevention and Control, Washington, DC, USA.
Palliat Support Care. 2023 Oct;21(5):820-828. doi: 10.1017/S1478951523000196.
Caregivers of adult phase 1 oncology trial patients experience high levels of distress and face barriers to in-person supportive care. The Phase 1 Caregiver LifeLine (P1CaLL) pilot study assessed the feasibility, acceptability, and general impact of an individual telephone-based cognitive behavioral stress-management (CBSM) intervention for caregivers of phase I oncology trial patients.
The pilot study involved 4 weekly adapted CBSM sessions followed by participant randomization to 4 weekly cognitive behavioral therapy sessions or metta-meditation sessions. A mixed-methods design used quantitative data from 23 caregivers and qualitative data from 5 caregivers to examine the feasibility and acceptability outcomes. Feasibility was determined using recruitment, retention, and assessment completion rates. Acceptability was assessed with self-reported satisfaction with program content and participation barriers. Baseline to post-intervention changes in caregiver distress and other psychosocial outcomes were assessed for the 8-session intervention.
The enrollment rate was 45.3%, which demonstrated limited feasibility based on an a priori criterion enrollment rate of 50%. Participants completed an average of 4.9 sessions, with 9/25 (36%) completing all sessions and an 84% assessment completion rate. Intervention acceptability was high, and participants found the sessions helpful in managing stress related to the phase 1 oncology trial patient experience. Participants showed reductions in worry and isolation and stress.
The P1CaLL study demonstrated adequate acceptability and limited feasibility and provided data on the general impact of the intervention on caregiver distress and other psychosocial outcomes. Caregivers of phase 1 oncology trial patients would benefit from supportive care services; a telephone-based intervention may have more utilization and thus make a larger impact.
成人 I 期肿瘤试验患者的照顾者经历高度的困扰，并面临面对面支持性护理的障碍。I 期癌症试验患者照顾者生命线（P1CaLL）试点研究评估了个体化电话式认知行为应激管理（CBSM）干预对 I 期肿瘤试验患者照顾者的可行性、可接受性和总体影响。
该试点研究包括每周 4 次适应性 CBSM 课程，随后对参与者进行随机分组，每周接受 4 次认知行为疗法或慈悲冥想课程。采用混合方法设计，使用 23 名照顾者的定量数据和 5 名照顾者的定性数据，评估可行性和可接受性结果。可行性通过招募、保留和评估完成率来确定。可接受性通过对计划内容和参与障碍的自我报告满意度来评估。对 8 节干预措施的照顾者困扰和其他心理社会结果进行了基线至干预后的变化评估。
入组率为 45.3%，根据 50%的预先设定的入组率，这表明可行性有限。参与者平均完成了 4.9 次课程，其中 9/25（36%）完成了所有课程，评估完成率为 84%。干预措施的可接受性很高，参与者发现这些课程有助于管理与 I 期肿瘤试验患者体验相关的应激。参与者表现出担忧、孤独和压力的减少。
P1CaLL 研究表明干预措施具有足够的可接受性和有限的可行性，并提供了干预对照顾者困扰和其他心理社会结果的总体影响的数据。I 期肿瘤试验患者的照顾者将受益于支持性护理服务；电话式干预可能会有更多的利用，从而产生更大的影响。
