Evaluating a digital tool for supporting people affected by breast cancer: a prospective randomized controlled trial-the ADAPT study.

IF 2.8 3区医学 Q2 HEALTH CARE SCIENCES & SERVICES

Supportive Care in Cancer Pub Date : 2024-10-21 DOI:10.1007/s00520-024-08923-3

Noelle J M C Vrancken Peeters, Olga Husson, Rafal Kulakowski, Emma Hainsworth, Emma Lidington, Sophie E McGrath, Jillian Noble, Leyla Azarang, Susanne Cruickshank, Sofia Georgopoulou

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引用次数: 0

Abstract

Purpose: This study reports the findings from the ADAPT randomized controlled trial (RCT), concerning the impact of a digital tool for supported self-management in people affected by breast cancer on patient activation as the primary outcome, with health-related quality of life (HRQoL), and health status as secondary outcomes.

Methods: Women with early-stage breast cancer were randomly assigned to standard care (control) or standard care in addition to the breast cancer digital tool (intervention). Data were collected using a demographic questionnaire, the Patient Activation Measure (PAM-13), the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline, 6 weeks, 3 months, 6 months, and 1 year from diagnosis. Linear mixed effect model regression was used to assess the effect of the digital tool over the first year from diagnosis while correcting for intra-participant correlation.

Results: A total of 166 participants were included, with 85 being randomized into the intervention. No significant differences (p > 0.05) in the PAM-13 scores, EORTC QLQ-C30 scales (global QoL, physical functioning, emotional functioning, pain, fatigue), and EQ-5D-5L Index between the control and intervention groups were observed. It is important to note that there was significant non-adherence within the intervention group.

Conclusion: The breast cancer digital tool had no statistically significant impact on patient activation, HRQoL, and health status over time compared to standard care alone in women with early-stage breast cancer. Future research should focus on identifying and addressing barriers to digital tool engagement to improve efficacy. Clinical trial information The study was registered at https://clinicaltrials.gov (NCT03866655) on 7 March 2019 ( https://clinicaltrials.gov/study/NCT03866655 ).

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评估支持乳腺癌患者的数字工具：前瞻性随机对照试验--ADAPT 研究。

目的：本研究报告了ADAPT随机对照试验（RCT）的结果，该试验以支持乳腺癌患者自我管理的数字工具对患者积极性的影响为主要结果，以健康相关生活质量（HRQoL）和健康状况为次要结果：方法：患有早期乳腺癌的妇女被随机分配到标准护理（对照组）或标准护理外加乳腺癌数字工具（干预组）。在基线期、确诊后 6 周、3 个月、6 个月和 1 年时，使用人口统计学问卷、患者激活测量（PAM-13）、欧洲癌症研究和治疗组织核心生活质量问卷（EORTC QLQ-C30）和 EuroQol 5 维 5 级问卷（EQ-5D-5L）收集数据。采用线性混合效应模型回归评估数字工具在确诊后第一年内的效果，同时校正参与者之间的相关性：共有 166 名参与者参与了研究，其中 85 人被随机纳入干预方案。对照组和干预组的 PAM-13 评分、EORTC QLQ-C30 量表（整体 QoL、身体功能、情绪功能、疼痛、疲劳）和 EQ-5D-5L 指数均无明显差异（P > 0.05）。值得注意的是，干预组存在严重的不依从现象：结论：与单纯的标准护理相比，乳腺癌数字化工具对早期乳腺癌女性患者的积极性、HRQoL和健康状况没有明显的统计学影响。未来的研究应侧重于识别和解决数字工具参与的障碍，以提高疗效。临床试验信息该研究于2019年3月7日在https://clinicaltrials.gov（NCT03866655）上注册 ( https://clinicaltrials.gov/study/NCT03866655 )。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Supportive Care in Cancer 医学-康复医学

CiteScore

5.70

自引率

9.70%

发文量

751

审稿时长

3 months

期刊介绍： Supportive Care in Cancer provides members of the Multinational Association of Supportive Care in Cancer (MASCC) and all other interested individuals, groups and institutions with the most recent scientific and social information on all aspects of supportive care in cancer patients. It covers primarily medical, technical and surgical topics concerning supportive therapy and care which may supplement or substitute basic cancer treatment at all stages of the disease. Nursing, rehabilitative, psychosocial and spiritual issues of support are also included.