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Table 1 WHO trial registration data set for the ReScreen study

From: Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial

Data category Information
Primary registry and trial identifying number ClinicalTrials.gov: NCT03434717
Date of registration in primary registry February 15, 2018
Secondary identifying numbers None
Source(s) of monetary or material support Skåne University Hospital, Department of Surgery and Gastroenterology
Primary sponsor Skåne University Hospital, Department of Surgery and Gastroenterology
Secondary sponsor(s) N/A
Contact for public queries MM. RN. PHD. Skåne University Hospital, Department of Surgery and Gastroenterology 22,185 Lund, Sweden
Contact for scientific queries MM. RN. PHD. Skåne University Hospital, Department of Surgery and Gastroenterology 22,185 Lund, Sweden
Public title Optimized rehabilitation following primary breast cancer surgery - Systematic screening as a tool for individualized rehabilitation
Scientific title Optimized rehabilitation following primary breast cancer surgery - Systematic screening as a tool for individualized rehabilitation: The ReScreen study
Countries of recruitment Sweden
Health condition(s) or problem(s) studied Breast cancer rehabilitation
Intervention(s) Intervention group: Patients with high distress receive individualized rehabilitation including evaluation of individual needs and based on that physical, psychological or social interventions to promote rehabilitation. Control and observational groups: care as usual
Key inclusion and exclusion criteria Inclusion criteria: Primary breast cancer, ≥18 years old, ability to communicate in Swedish. Exclusion criteria: Recurrent disease, pregnancy, cognitive impairment, severe mental illness and drug addiction.
Study type Interventional. Allocation: Randomized, 3-armed. Masking: Blinded at allocation level. Primary purpose: Optimized rehabilitation
Date of first enrolment May 2019
Target sample size 950
Recruitment status Recruiting
Primary outcome(s) Distress
Key secondary outcomes Quality of Life, anxiety and depression, resilience, physical activity, health related behaviours, care satisfaction, health care utilization and sickness absence, patient and relatives experiences
Ethics Review Regional Ethical Review Board in Lund, Sweden (reference number 2015/505)
Individual participant-level data (IPD) sharing statement The IPD will not be shared