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一项为期 6 周的强化转移性癌症女性适应力的方案:一项随机临床试验。

A 6-Week Program to Strengthen Resiliency Among Women With Metastatic Cancer: A Randomized Clinical Trial.

机构信息

Department of Medicine and Physical Medicine and Rehabilitation and Patient and Family Support Program at Cedars-Sinai Cancer, Los Angeles, CA, USA.

Division of Population Sciences, Cedars-Sinai Cancer, Los Angeles, CA, USA.

出版信息

Oncologist. 2023 Aug 3;28(8):e669-e682. doi: 10.1093/oncolo/oyad091.

Abstract

PURPOSE

The objective of this study was to evaluate the effect of an intervention (Growing Resilience And CouragE; GRACE) on spiritual well-being, quality of life, and general well-being in women with metastatic cancers reporting existential or spiritual distress.

PATIENTS AND METHODS

Prospective, randomized, wait-list control clinical trial. Women with metastatic cancer experiencing existential or spiritual concerns were randomized to GRACE or waitlist control. Survey data were collected at baseline, end of program, and 1-month follow-up. Participants included English-speaking women, 18 or older, with metastatic cancer, existential or spiritual concerns, and reasonable medical stability. Eighty-one women were assessed for eligibility; 10 were excluded (not meeting exclusion criteria, refusal to participate, and death). The primary outcome was spiritual well-being measured pre- and post-program. Secondary measures assessed quality of life, anxiety, depression, hopelessness, and loneliness.

RESULTS

Seventy-one women (aged 47-72) were enrolled (GRACE n = 37, waitlist control n = 34). GRACE participants demonstrated significant improvements in spiritual well-being compared to control at end of program (parameter estimate (PE), 16.67, 95% CI, 13.17, 20.16) and 1-month follow-up (PE, 10.31, 95% CI, 6.73, 13.89). Additionally, significant improvements were demonstrated in quality of life at the end of program (PE, 8.51, 95% CI, 4.26, 12.76) and 1-month follow-up (PE, 6.17, 95% CI, 1.75, 10.58). GRACE participants also demonstrated improved depression and hopelessness at follow-up, as well as improved anxiety.

CONCLUSIONS

Findings suggest the value of evidence-based psychoeducational and experiential interventions for improving the well-being and quality of life of women with advanced cancer.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02707510.

摘要

目的

本研究旨在评估一项干预措施(增强韧性和勇气;GRACE)对报告存在或精神困扰的转移性癌症女性的精神幸福感、生活质量和整体幸福感的影响。

患者和方法

前瞻性、随机、等待名单对照临床试验。患有转移性癌症并经历存在或精神困扰的女性被随机分配到 GRACE 或等待名单对照组。在基线、方案结束时和 1 个月随访时收集调查数据。参与者包括英语为母语、18 岁或以上、患有转移性癌症、存在或精神困扰以及合理医疗稳定的女性。81 名女性符合入选条件;10 名被排除(不符合排除标准、拒绝参与和死亡)。主要结局是在方案前后测量精神幸福感。次要测量指标评估生活质量、焦虑、抑郁、绝望和孤独。

结果

71 名女性(年龄 47-72 岁)入组(GRACE 组 n = 37,等待名单对照组 n = 34)。与对照组相比,GRACE 组参与者在方案结束时(参数估计值(PE),16.67,95%置信区间,13.17,20.16)和 1 个月随访时(PE,10.31,95%置信区间,6.73,13.89)的精神幸福感显著提高。此外,在方案结束时(PE,8.51,95%置信区间,4.26,12.76)和 1 个月随访时(PE,6.17,95%置信区间,1.75,10.58),生活质量也显著提高。GRACE 组在随访时还表现出抑郁和绝望情绪的改善,以及焦虑情绪的改善。

结论

研究结果表明,基于证据的心理教育和体验干预措施对改善晚期癌症女性的幸福感和生活质量具有重要价值。

试验注册

ClinicalTrials.gov 标识符:NCT02707510。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/10400157/657a75f40e09/oyad091_fig1.jpg

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