Skip to main content
OpenTrials
Completed

NCT Number: NCT07724314

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Training and Research Hospital

Samsun, 55105, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web-Based Alopecia Education Program

Behavioral

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.

Primary outcomes

  1. Body Image Scale Score

    Time frame: 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.

  2. Rosenberg Self-Esteem Scale Score

    Time frame: 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.

  3. WHO-5 Well-Being Index Score

    Time frame: 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.

  4. Chemotherapy-Induced Alopecia Quality of Life Scale Score

    Time frame: 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.

Other outcomes

  1. Alopecia Information Form-1

    Time frame: 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.

  2. Alopecia Information Form-2

    Time frame: 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.

  3. Web-Based Alopecia Education Program Evaluation Form

    Time frame: 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.

  4. System Usability Scale Score

    Time frame: 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.

  5. Website Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gulay Akman

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.