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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07724314
Enrollment
68
Registered
2026-07-24
Start date
2018-07-02
Completion date
2019-05-03
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chemotherapy-Induced Alopecia

Keywords

Breast Cancer, Chemotherapy-Induced Alopecia, Body Image, Self-Esteem, Quality of Life, Psychological Well-Being, Supportive Care, Web-Based Education, Nursing Care

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALWeb-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.

Sponsors

Gulay Akman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor was blinded to participants' group assignments. Participants and the researcher delivering the intervention could not be blinded because of the nature of the web-based educational intervention.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body Image Scale ScoreBaseline (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.
Rosenberg Self-Esteem Scale ScoreBaseline (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.
WHO-5 Well-Being Index ScoreBaseline (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.
Chemotherapy-Induced Alopecia Quality of Life Scale ScoreWeek 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORGulay Akman, PhD

Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey

STUDY_CHAIRHatice Balci Yangin, PhD

Faculty of Nursing, Akdeniz University, Antalya, Turkey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026