Table 1 WHO trial registration data set for the ReScreen study
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 |