Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT02056483
The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.
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Notify Me18 year and older
Female
Interventional
Not applicable
Copenhagen, 2100, Denmark
In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Screening-based nurse navigation for breast cancer rehabilitation
Time frame: 6 and 12 months
Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer
Time frame: 6 and 12 months
Difference in change in patient reported health related quality of life between patients in the intervention and control group. Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales.
Time frame: 6 and 12 months
Difference in change in patient reported anxiety and depression between patients in the intervention and control group. Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS).
Time frame: 6 and 12 months
Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
Time frame: 6 and 12 months
Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
Time frame: 6 and 12 months
Difference in change in patient reported body masss index between patients in intervention and control group.
Time frame: 6 and 12 months
Difference in change in patient reported physical activity between patients in intervention and control group.
Time frame: 6 and 12 months
Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.
Danish Cancer Society
Other
Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
Acronym: REBECCA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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