Effects of a Web-Based Alopecia Education Program in Women With Breast Cancer
23 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
68
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Samsun
-
Samsun, Samsun, Turquia (Türkiye), 55105
- Samsun Training and Research Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Image Scale Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Alopecia Information Form-1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Gulay Akman, PhD, Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey
- Cadeira de estudo: Hatice Balci Yangin, PhD, Faculty of Nursing, Akdeniz University, Antalya, Turkey
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de julho de 2018
Conclusão Primária (Real)
3 de maio de 2019
Conclusão do estudo (Real)
3 de maio de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
14 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2026
Primeira postagem (Real)
24 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CIA-EDU-WEB-RCT-2019-01
- 54 (Outro identificador: Ondokuz Mayis University Clinical Research Ethics Committee)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .