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Effects of a Web-Based Alopecia Education Program in Women With Breast Cancer

2026年7月23日 更新者：Gulay Akman

Effect of a Web-Based Alopecia Education Program on Body Image, Self-Esteem, Quality of Life, and Well-Being Among Women With Breast Cancer: A Randomized Controlled Trial

This randomized controlled trial evaluated the effects of a web-based alopecia education program on body image, self-esteem, chemotherapy-induced alopecia-related quality of life, and psychological well-being among women with breast cancer receiving chemotherapy. A total of 68 women were randomly assigned to the intervention or routine-care control group. Participants in the intervention group received access to a web-based educational and supportive care program throughout chemotherapy, whereas participants in the control group received routine care. Outcomes were assessed at predefined time points before the first, second, and final chemotherapy cycles.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Chemotherapy-induced alopecia is a visible and potentially distressing adverse effect of breast cancer treatment that may affect women's body image, self-esteem, quality of life, and psychological well-being. Providing timely, structured, and accessible information may support women in preparing for hair loss and managing its psychosocial consequences.

This study was conducted as a single-blind, parallel-group randomized controlled trial. Women with breast cancer who were receiving chemotherapy for the first time were allocated to a web-based alopecia education program or routine care. The education program was developed to provide evidence-based information about chemotherapy-induced alopecia, expected changes in hair and scalp, strategies for preparation and self-care, options for managing appearance-related concerns, and approaches for coping with the emotional and social effects of hair loss. Participants were able to access the educational content through the web during their chemotherapy treatment. The study examined whether the web-based education program improved body image, self-esteem, alopecia-related quality of life, and psychological well-being compared with routine care. The usability of the web-based program was also evaluated among participants who received the intervention.

研究类型

介入性

注册 (实际的)

68

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Samsun
      • Samsun、Samsun、土耳其（türkiye）、55105
        • Samsun Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Female participants aged 18 to 65 years.
  • Diagnosed with stage I or stage II breast cancer.
  • Receiving chemotherapy for the first time.
  • Scheduled to receive one of the following 21-day chemotherapy regimens: doxorubicin plus cyclophosphamide (AC); epirubicin plus cyclophosphamide (EC); docetaxel plus cyclophosphamide (TC); cyclophosphamide, doxorubicin, and fluorouracil (CAF); cyclophosphamide, epirubicin, and fluorouracil (CEF); or docetaxel, doxorubicin, and cyclophosphamide (TAC).
  • Scheduled to receive a chemotherapy regimen expected to cause grade 2 alopecia according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03).
  • Eastern Cooperative Oncology Group (ECOG), World Health Organization (WHO), or Zubrod performance status of 0 to 2.
  • Able to read, write, and communicate in Turkish.
  • Had access to a computer or internet-enabled mobile phone.
  • Willing to participate in the study and provide informed consent.

Exclusion Criteria:

  • Diagnosed with stage III or stage IV breast cancer.
  • History of another malignancy.
  • History of alopecia before the current chemotherapy treatment.
  • Previous mastectomy.
  • History of a disease or condition that caused a visible alteration in physical appearance.
  • Diagnosed psychiatric disorder.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Web-Based Alopecia Education Group
Participants received routine care in addition to access to the web-based alopecia education program during chemotherapy. The program provided structured information and supportive guidance on chemotherapy-induced alopecia, preparation for hair loss, hair and scalp care, appearance management, and coping with the psychosocial effects of alopecia.
行为的：Web-Based Alopecia Education Program
A structured web-based educational and supportive care program designed for women with breast cancer receiving chemotherapy. The program included information about chemotherapy-induced alopecia, the expected course of hair loss and regrowth, preparation before hair loss, hair and scalp care, use of wigs and head coverings, appearance-related concerns, and strategies for coping with emotional and social effects.
无干预：Routine Care Control Group
Participants received routine care provided by the chemotherapy unit and did not receive access to the web-based alopecia education program during the study period.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Body Image Scale Score
大体时间：Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Body image was assessed using the 40-item Body Image Scale. Each item is scored from 1 to 5, yielding a total score ranging from 40 to 200. Higher scores indicate greater satisfaction with body image, whereas scores below 135 indicate lower body-image satisfaction. Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Rosenberg Self-Esteem Scale Score
大体时间：Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Self-esteem was assessed using the 10-item self-esteem subscale of the Rosenberg Self-Esteem Scale. Items are scored from 0 to 3, yielding a total score ranging from 0 to 30, with higher scores indicating higher self-esteem. Changes in scores over time and differences between the intervention and control groups were evaluated.
Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
WHO-5 Well-Being Index Score
大体时间：Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Psychological well-being was assessed using the World Health Organization-Five Well-Being Index Score (WHO-5 Well-Being Index Score). Each item is scored from 0 to 5, yielding a raw score ranging from 0 to 25. The raw score was multiplied by four to obtain a percentage score ranging from 0 to 100. Higher scores indicate better psychological well-being, whereas scores below 50 indicate low well-being and the need for further evaluation. Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
Baseline (immediately before the first chemotherapy cycle); Week 3 (immediately before the second chemotherapy cycle); and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Chemotherapy-Induced Alopecia Quality of Life Scale Score
大体时间：Week 3 (immediately before the second chemotherapy cycle) and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Alopecia-related quality of life was assessed using the 19-item Chemotherapy-Induced Alopecia Quality of Life Scale. Each item is scored from 1 to 5, yielding a total score ranging from 19 to 95. The scale comprises three subdomains: impact on general life, negative impact on inner life, and positive thoughts. Items 2, 15, 16, and 17 are reverse scored. Higher total scores indicate better alopecia-related quality of life, whereas lower scores indicate greater deterioration in quality of life. The scale was administered before the second and final chemotherapy cycles; it was not administered before the first chemotherapy cycle because participants had not yet experienced chemotherapy-induced alopecia. Changes in scores over time and differences between the web-based alopecia education group and the routine-care control group were evaluated.
Week 3 (immediately before the second chemotherapy cycle) and Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).

其他结果措施

结果测量
措施说明
大体时间
Alopecia Information Form-1
大体时间：Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
Alopecia Information Form-1 (Alopecia Characteristics and Self-Care Practices) was a researcher-developed questionnaire based on the literature. It assessed chemotherapy-induced alopecia severity using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); scalp condition; distribution and onset of scalp hair loss; hair loss in other body regions; timing of hair loss in different body regions; and practices used to prevent, reduce, or manage hair loss. The form also included items on employment status during treatment and the perceived impact of treatment-related expenses on the participant's budget. The form did not generate a total score. Responses were recorded as categorical variables and summarized as frequencies and percentages for the intervention and control groups.
Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
Alopecia Information Form-2
大体时间：Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Alopecia Information Form-2 (Alopecia Management and Psychosocial Responses) was a researcher-developed questionnaire based on the literature. It assessed chemotherapy-induced alopecia severity using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); hair loss in other body regions; use of wigs, scarves, hats, or other appearance-management and camouflage methods; practices intended to promote hair regrowth; changes in mirror-viewing frequency; and thoughts and emotional responses related to scalp and body-hair loss. The form did not generate a total score. Responses were recorded as categorical variables and summarized as frequencies and percentages for the intervention and control groups.
Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Web-Based Alopecia Education Program Evaluation Form
大体时间：Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
The acceptability and perceived usefulness of the web-based alopecia education program were assessed in the intervention group using a four-item researcher-developed Web-Based Alopecia Education Program Evaluation Form. The form assessed whether the program helped participants cope with chemotherapy-induced alopecia, which section of the program was perceived as most helpful, whether any section was considered unhelpful, and whether participants would recommend the program to other women experiencing chemotherapy-induced alopecia. The form did not generate a total score. Responses were recorded as categorical variables and summarized as frequencies and percentages.
Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
System Usability Scale Score
大体时间：Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
The perceived usability of the web-based alopecia education program was assessed in the intervention group using the 10-item System Usability Scale. Each item was rated on a 5-point response scale from 0 to 4. Negatively worded items were reverse scored. Adjusted item scores were summed and multiplied by 2.5 to obtain a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Website Use
大体时间：From baseline (immediately before the first chemotherapy cycle) through Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
Website engagement was recorded through the administrative panel. Measures included the total number of website visits and the cumulative duration of website use in minutes during the intervention period.
From baseline (immediately before the first chemotherapy cycle) through Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gulay Akman

调查人员

  • 首席研究员：Gulay Akman, PhD、Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey
  • 学习椅：Hatice Balci Yangin, PhD、Faculty of Nursing, Akdeniz University, Antalya, Turkey

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Akman, G. (2019). Meme kanseri olan kadınlara uygulanan web tabanlı alopesi eğitim programının beden imajına, benlik saygısına, yaşam kalitesine ve iyilik durumuna etkisi [The effect of a web-based alopecia education program on body image, self-esteem, quality of life, and well-being among women with breast cancer] [Doctoral dissertation, Akdeniz University]. Council of Higher Education National Thesis Center.

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年7月2日

初级完成 (实际的)

2019年5月3日

研究完成 (实际的)

2019年5月3日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年7月24日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CIA-EDU-WEB-RCT-2019-01
  • 54 (其他标识符：Ondokuz Mayis University Clinical Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

De-identified individual participant data generated and analyzed during this study are not planned to be shared because no prospective data-sharing plan was established and the ethical and consent-related conditions required for external sharing of individual-level data have not been confirmed. Aggregated data may be available from the corresponding author upon reasonable request, subject to ethical and institutional approval.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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