REBECCA II: Rehabilitation After Breast Cancer
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Individually tailored nurse navigation |
Behavioral: Individually 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.
|
| No Intervention: Control Usual care |
Outcome Measures
Primary Outcome Measures
- Distress [Change from baseline and to 6,12 months (mixed models)]
Distress Thermometer
Secondary Outcome Measures
- Distress [Change from baseline to 6 months]
Distress Thermometer
- Distress [Change from baseline to 12 months]
Distress Thermometer
- Distress [Change from baseline to 18 months]
Distress Thermometer
- Depression [Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)]
The Patient Health Questionnaire (PHQ9)
- Depression [Change from baseline and to 6 months]
The Patient Health Questionnaire (PHQ9)
- Depression [Change from baseline and to 12 months]
The Patient Health Questionnaire (PHQ9)
- Depression [Change from baseline and to 18 months]
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)
- Anxiety [Change from baseline and to 6 months]
Generalized Anxiety Disorder (GAD7)
- Anxiety [Change from baseline and to 12 months]
Generalized Anxiety Disorder (GAD7)
- Anxiety [Change from baseline and to 18 months]
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)
- Health related quality of life summary index [Change from baseline and to 6 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)
- Health related quality of life summary index [Change from baseline and to 12 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)
- 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)
- 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)
- Breast cancer related quality of life summary index [Change from baseline and to 6 months]
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 12 months]
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 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 3, 10, 18 weeks, 6,12,18 months (mixed models)]
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- Functional related quality of life summary index [Change from baseline and to 6 months]
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- Functional related quality of life summary index [Change from baseline and to 12 months]
Functional wellbeing (FWB) 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)
- 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)
- Physical health related quality of life [Change from baseline and to 6 months]
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- Physical health related quality of life [Change from baseline and to 12 months]
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- 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 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)
- Social health related quality of life [Change from baseline and to 6 months]
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- Social health related quality of life [Change from baseline and to 12 months]
Social/Family well-being (SWB) 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 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)
- Emotional health related quality of life [Change from baseline and to 6 months]
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
- Emotional health related quality of life [Change from baseline and to 12 months]
Emotional well-being (EWB) 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)
- Self-efficacy [Change from baseline and to 6,12,18 months (mixed models)]
Patient Activation Measure (PAM)
- Self-efficacy [Change from baseline and to 6 months]
Patient Activation Measure (PAM)
- Self-efficacy [Change from baseline and to 12 months]
Patient Activation Measure (PAM)
- Self-efficacy [Change from baseline and to 18 months]
Patient Activation Measure (PAM)
- Fear of recurrence [6 months]
Concerns About Recurrence Questionnaire (CARQ)
- Fear of recurrence [12 months]
Concerns About Recurrence Questionnaire (CARQ)
- 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 6,12,18 months (mixed models)]
Self-developed scale
- Pain in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 6 months]
Self-developed scale
- Pain in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 12 months]
Self-developed scale
- Pain in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 18 months]
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
- Neuropathy in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 6 months]
Self-developed scale
- Neuropathy in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 12 months]
Self-developed scale
- Neuropathy in the breast surgery area (side of chest, armpit or arm) [Change from baseline and to 18 months]
Self-developed scale
- Sleep quality [Change from baseline and to 6,12,18 months (mixed models)]
Pittsburgh Sleep Quality Index (PSQI)
- Sleep quality [Change from baseline and to 6 months]
Pittsburgh Sleep Quality Index (PSQI)
- Sleep quality [Change from baseline and to 12 months]
Pittsburgh Sleep Quality Index (PSQI)
- Sleep quality [Change from baseline and to 18 months]
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 6 months]
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 - 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
- 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 - Impact of Perceived cognitive impairments on quality of life [Change from baseline and to 6 months]
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
- Cognitive function - Impact of Perceived cognitive impairments on quality of life [Change from baseline and to 12 months]
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
- 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
- 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
- Cognitive function - Perceived cognitive abilities [Change from baseline and to 6 months]
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
- Cognitive function - Perceived cognitive abilities [Change from baseline and to 12 months]
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
- 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
- Need for support [Change from baseline and to 6,12,18 months (mixed models)]
Single self-developed items
- Need for support [Change from baseline and to 6 months]
Single self-developed items
- Need for support [Change from baseline and to 12 months]
Single self-developed items
- 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
Other Outcome Measures
- Social support [Baseline]
Modified Medical Outcomes Study Social Support Scale (MOS)
Eligibility Criteria
Criteria
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,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | DK-2100 |
Sponsors and Collaborators
- Danish Cancer Society
- Rigshospitalet, Denmark
- Copenhagen University Hospital at Herlev
Investigators
- Principal Investigator: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- Principal Investigator: Christoffer Johansen, DMSc, Rigshispitalet
- Study Chair: Birgitte Mertz, RN, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REBECCA II