Effects of a Web-Based Alopecia Education Program in Women With Breast Cancer
2026년 7월 23일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
68
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Samsun
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Samsun, Samsun, 터키 (Türkiye), 55105
- Samsun Training and Research Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body Image Scale Score
기간: 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).
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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.
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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).
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Rosenberg Self-Esteem Scale Score
기간: 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).
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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.
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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).
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WHO-5 Well-Being Index Score
기간: 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).
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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.
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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).
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Chemotherapy-Induced Alopecia Quality of Life Scale Score
기간: 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).
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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.
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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).
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Alopecia Information Form-1
기간: Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
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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.
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Week 3 (immediately before the second chemotherapy cycle; each chemotherapy cycle was 21 days).
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Alopecia Information Form-2
기간: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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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.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Web-Based Alopecia Education Program Evaluation Form
기간: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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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.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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System Usability Scale Score
기간: Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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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.
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Week 9 or Week 15 (immediately before the final chemotherapy cycle; cycles were 21 days, with 4 or 6 cycles depending on regimen).
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Website Use
기간: 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).
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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.
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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).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Gulay Akman, PhD, Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey
- 연구 의자: Hatice Balci Yangin, PhD, Faculty of Nursing, Akdeniz University, Antalya, Turkey
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 7월 2일
기본 완료 (실제)
2019년 5월 3일
연구 완료 (실제)
2019년 5월 3일
연구 등록 날짜
최초 제출
2026년 7월 14일
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CIA-EDU-WEB-RCT-2019-01
- 54 (기타 식별자: Ondokuz Mayis University Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .