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

NCT07724314 | Completed

• 2 other identifiers: CIA-EDU-WEB-RCT-2019-0154
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Body Image Scale Score

  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

  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

  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

  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).

Other Outcomes (5)

• Alopecia Information Form-1

  Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).

• Alopecia Information Form-2

  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

  Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).

Study Arms (2)

Web-Based Alopecia Education Group

EXPERIMENTAL

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.

Behavioral: Web-Based Alopecia Education Program

Routine Care Control Group

NO INTERVENTION

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.

Interventions

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.

Web-Based Alopecia Education Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulay Akman: lead

Study Sites (1)

Samsun Training and Research Hospital

Samsun, Samsun, 55105, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Doctoral dissertation describing the study methods and results

MeSH Terms

Conditions

Breast Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Personal Satisfaction; Behavior

Study Officials

• Gulay Akman, PhD

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

  PRINCIPAL INVESTIGATOR

• Hatice Balci Yangin, PhD

  Faculty of Nursing, Akdeniz University, Antalya, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 24, 2026
• Study Start: July 2, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)