Breast Cancer
Conditions
Keywords
Breast cancer, Psychosocial intervention
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.
Interventions
BEHAVIORALIndividually tailored nurse navigation
The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
Sponsors
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Danish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Intervention status will be blinded in analyses.
Intervention model 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 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distress | Change from baseline and to 6,12 months (mixed models) | Distress Thermometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for support | Change from baseline and to 6,12,18 months (mixed models) | Single self-developed items |
| Distress | Change from baseline to 6 months | Distress Thermometer |
| Depression | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | The Patient Health Questionnaire (PHQ9) |
| Anxiety | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | Generalized Anxiety Disorder (GAD7) |
| Health related quality of life summary index | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | 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) |
| Breast cancer related quality of life summary index | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | 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 3, 10, 18 weeks, 6,12,18 months (mixed models) | Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B) |
| 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 |
| Physical health related quality of life | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | 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 3, 10, 18 weeks, 6,12,18 months (mixed models) | Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B) |
| Self-efficacy | Change from baseline and to 6,12,18 months (mixed models) | Patient Activation Measure (PAM) |
| Fear of recurrence | 6 months | Concerns About Recurrence Questionnaire (CARQ) |
| Pain in the breast surgery area (side of chest, armpit or arm) | Change from baseline and to 6,12,18 months (mixed models) | Self-developed scale |
| Neuropathy in the breast surgery area (side of chest, armpit or arm) | Change from baseline and to 6,12,18 months (mixed models) | Self-developed scale |
| Sleep quality | Change from baseline and to 6,12,18 months (mixed models) | Pittsburgh Sleep Quality Index (PSQI) |
| Cognitive function - Perceived cognitive impairments | Change from baseline and to 6,12,18 months (mixed models) | Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments |
| 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 |
| Cognitive function - Impact of Perceived cognitive impairments on quality of life | Change from baseline and to 6,12,18 months (mixed models) | Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life |
| Cognitive function - Perceived cognitive abilities | Change from baseline and to 6,12,18 months (mixed models) | Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities |
| Acceptability | 18 months | Single self-developed items |
| Emotional health related quality of life | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) | Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social support | Baseline | Modified Medical Outcomes Study Social Support Scale (MOS) |
Countries
Denmark
Outcome results
None listed