Rehabilitation After Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Individually tailored nurse navigation
- Registration Number
- NCT03254875
- Lead Sponsor
- Danish Cancer Society
- Brief Summary
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
- Detailed Description
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 309
- Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
- no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Individually tailored nurse navigation Individually tailored nurse navigation
- Primary Outcome Measures
Name Time Method Distress Change from baseline and to 6,12 months (mixed models) Distress Thermometer
- Secondary Outcome Measures
Name Time Method Health related quality of life summary index Change from baseline and to 18 months The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
* Physical well-being (PWB)
* Functional wellbeing (FWB)
* BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)Anxiety Change from baseline and to 18 months Generalized Anxiety Disorder (GAD7)
Neuropathy in the breast surgery area (side of chest, armpit or arm) Change from baseline and to 18 months Self-developed scale
Distress Change from baseline to 18 months Distress Thermometer
Breast cancer related quality of life summary index Change from baseline and to 18 months BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Functional related quality of life summary index Change from baseline and to 18 months Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Fear of recurrence 18 months Concerns About Recurrence Questionnaire (CARQ)
Pain in the breast surgery area (side of chest, armpit or arm) Change from baseline and to 18 months Self-developed scale
Cognitive function - Perceived cognitive impairments Change from baseline and to 18 months Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Depression Change from baseline and to 18 months The Patient Health Questionnaire (PHQ9)
Physical health related quality of life Change from baseline and to 18 months Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Social health related quality of life Change from baseline and to 18 months Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Emotional health related quality of life Change from baseline and to 18 months Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Cognitive function- Perceived cognitive impairments Change from baseline and to 12 months Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Self-efficacy Change from baseline and to 18 months Patient Activation Measure (PAM)
Sleep quality Change from baseline and to 18 months Pittsburgh Sleep Quality Index (PSQI)
Cognitive function - Perceived cognitive abilities Change from baseline and to 18 months Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Cognitive function - Impact of Perceived cognitive impairments on quality of life Change from baseline and to 18 months Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Need for support Change from baseline and to 18 months Single self-developed items
Health care costs Cumulative from baseline to 18 months Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
Acceptability 18 months Single self-developed items
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark