Thana Kanjana, Sikorskii Alla, Lehto Rebecca, Guhaniyogi Pratim, Brewer Sarah, Victorson David, Pace Thaddeus, Badger Terry, Wyatt Gwen
College of Nursing, Michigan State University, 1355 Bogue Street, East Lansing, MI, 48824, USA.
Faculty of Nursing, Chiang Mai University, 110/406 Inthawaroros Road, Chiang Mai, 50200, Thailand.
Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5.
To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients' symptoms.
In this SMART, patient-caregiver dyads were initially randomized to 4 weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4 weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4 weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models.
In the comparison of 4 adaptive intervention sequences: reflexology for 8 weeks, reflexology for 4 weeks followed by MP for 4 weeks if no response to reflexology, MP for 8 weeks, and MP for 4 weeks followed by reflexology for 4 weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4 weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one.
Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains.
ClinicalTrials.gov Identifier: NCT02759146.
对参与一项为期12周的反射疗法和/或冥想练习（MP）序贯多重分配随机试验（SMART）以管理癌症患者症状的照护者进行一项聚焦于健康相关生活质量（HRQOL）的二次分析。
在这项SMART中，患者-照护者二元组最初被随机分为三组：为患者提供为期4周的照护者实施的反射疗法（N = 150）、与患者一起进行MP（N = 150）或对照组（N = 47）。4周后，疲劳症状未改善的二元组患者（无反应者，反射疗法组n = 69，MP组n = 57）被重新随机分组，继续接受相同疗法或额外增加另一种疗法，为期4周。使用患者报告结局测量信息系统（PROMIS）简表29和照护者反应评估工具（CRAT）来测量第12周时照护者的HRQOL以及照护者负担；使用一般线性模型对得分进行分析。
在比较4种适应性干预序列时：8周反射疗法、若对反射疗法无反应则先进行4周反射疗法再进行4周MP、8周MP、若对MP无反应则先进行4周MP再进行4周反射疗法，PROMIS - 29得分无差异。然而，在MP的前4周后增加反射疗法时，CRAT中关于对日程安排的影响、家庭支持和财务方面的领域情况恶化。与继续进行相同干预相比，增加任何一种干预都会使CRAT中的健康领域情况恶化。
临床医生应意识到，照护者参与不止一种补充疗法可能会在某些领域增加照护者负担，但不会影响其他HRQOL领域。
ClinicalTrials.gov标识符：NCT02759146。
