HYPofractionated Adjuvant RadioTherapy in 1 versus 2 weeks in high-risk patients with breast cancer (HYPART): a non-inferiority, open-label, phase III randomised trial
In this study, we will compare a 1-week schedule of hypofractionated adjuvant whole breast/chest wall and/or regional nodal radiotherapy against 2 weeks for locoregional disease control, toxicities, quality of life (QoL), survival and second cancers after primary surgery in patients with breas t cancer.MethodsEligible patients with breast cancer after mastectomy or breast conserving surgery (BCS) will be treated with a radiotherapy dose of 26 Gy in 5 fractions over 1 week in the study arm and 34 Gy in 10 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials

Enhancing educational and vocational recovery in adolescents and young adults with early psychosis through Supported Employment and Education (SEEearly): study protocol for a multicenter randomized controlled trial
DiscussionIn SEEearly, we hypothesize that participants with psychosis, who receive TAU plus SEE, present with better primary and secondary outcomes than participants, who receive TAU alone. Positive results of this study will justify SEE as an evidence-based strategy for clinical routine treatment in people with early psychosis.Trial registrationSEEearly was registered nationally and internationally in the German Clinical Trials Register (DRKS; identifier: DRKS00029660) on October 14, 2022. (Source: Trials)
Source: Trials - July 3, 2023 Category: Research Source Type: clinical trials

A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study
DiscussionTo increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions for patients most in need of effective and efficient HIV care delivery strategies.Trial registrationClinicalTrials.gov NCT05090150. Registered on October 22, 2021 (Source: Trials)
Source: Trials - January 17, 2023 Category: Research Source Type: clinical trials

Effect of “Mehrpishegan” web-based support group on depression, anxiety, and stress among elderly informal caregivers: a protocol for a randomized-controlled trial
This study stands as an opportunity to address the needs of caregivers and help them support each other in a novel way.Trial registrationIran Randomized Clinical Trial CenterIRCT20201012048999N1. Registered on 25 December 2020 (current status: ongoing).The World Health Organization Trial Registration Data Set is in Additional file 1Protocol versionSecond version 2021-05-27 (Source: Trials)
Source: Trials - May 17, 2022 Category: Research Source Type: clinical trials

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population
This study will fill this gap.Trial registrationISRCTN Registry:ISRCTN11318024. Registered on 17 May 2018. (Source: Trials)
Source: Trials - May 31, 2020 Category: Research Source Type: clinical trials

Impact of Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
Conditions:   Breast Carcinoma;   Mammoplasty Patient Interventions:   Other: Diary;   Other: Questionnaire Administration Sponsors:   M.D. Anderson Cancer Center;   National Cancer Institute (NCI) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 20, 2019 Category: Research Source Type: clinical trials