Last reviewed · How we verify
NCT04098783
Health Belief Model Based Nursing Interventions on Lymphedema Prevention
NA trial testing Home visit, health education in Breast Cancer in 72 participants. Completed in 13 July 2017.
15 April 2017
Quick facts
| Lead sponsor | Ayse Cal |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 72 |
| Start date | 15 May 2016 |
| Primary completion | 15 April 2017 |
| Estimated completion | 13 July 2017 |
Drugs / interventions tested
- Home visit, health education
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast Cancer Lymphedema — all drugs for Breast Cancer Lymphedema →
- Home Visit — all drugs for Home Visit →
Sponsor
Ayse Cal
Who can join
Adults 28 to 77, female only, with Breast Cancer or Breast Cancer Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim: The study was performed to examine effects of Health Belief Model based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery. Methods: The study had an experimental design. 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The study had an experimental design. Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at three-month intervals. Hypotheses of the study 1. Extremity function restrictions will be lower in the intervention group than in the control group. 2. Self-efficacy levels will be higher in the intervention group than in the control group. 3. Functions improving the quality of life will be higher in the intervention group than in the control group. 4. There will be fewer symptoms reducing the quality of life in the intervention group than in the control group. 5. The incidence of lymphedema will be lower in the intervention group than in the control group. 6. The mean cost of the intervention group at home visits, will be lower than in the control group. What does this paper contribute? * Nurses can play an effective role in enabling women undergoing breast surgery to acquire behavior of lymphedema prevention. This may reduce treatment costs. * Future research should evaluate collaborative models of care in general practice aimed at improving lymphedema prevention for women undergoing breast surgery. * Policymakers should consider introducing funding measures for breast cancer survivors by nurses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04098783
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04098783 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ayse Cal
- Last refreshed: 7 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04098783.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing