Rehabilitation After Breast Cancer

Breast Cancer Clinical Trial

— REBECCA II  

Official title:

Individually Tailored Rehabilitation After Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254875
• Other study ID #: REBECCA II
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Cancer Society	Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social support	Modified Medical Outcomes Study Social Support Scale (MOS)	Baseline
Primary	Distress	Distress Thermometer	Change from baseline and to 6,12 months (mixed models)
Secondary	Distress	Distress Thermometer	Change from baseline to 6 months
Secondary	Distress	Distress Thermometer	Change from baseline to 12 months
Secondary	Distress	Distress Thermometer	Change from baseline to 18 months
Secondary	Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 6 months
Secondary	Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 12 months
Secondary	Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 18 months
Secondary	Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 6 months
Secondary	Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 12 months
Secondary	Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 18 months
Secondary	Health related quality of life summary index	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)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Health related quality of life summary index	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)	Change from baseline and to 6 months
Secondary	Health related quality of life summary index	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)	Change from baseline and to 12 months
Secondary	Health related quality of life summary index	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)	Change from baseline and to 18 months
Secondary	Breast cancer related quality of life summary index	BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Breast cancer related quality of life summary index	BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 6 months
Secondary	Breast cancer related quality of life summary index	BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 12 months
Secondary	Breast cancer related quality of life summary index	BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 18 months
Secondary	Functional related quality of life summary index	Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Functional related quality of life summary index	Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 6 months
Secondary	Functional related quality of life summary index	Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 12 months
Secondary	Functional related quality of life summary index	Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 18 months
Secondary	Physical health related quality of life	Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Physical health related quality of life	Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 6 months
Secondary	Physical health related quality of life	Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 12 months
Secondary	Physical health related quality of life	Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 18 months
Secondary	Social health related quality of life	Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Social health related quality of life	Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 6 months
Secondary	Social health related quality of life	Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 12 months
Secondary	Social health related quality of life	Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 18 months
Secondary	Emotional health related quality of life	Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Secondary	Emotional health related quality of life	Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 6 months
Secondary	Emotional health related quality of life	Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 12 months
Secondary	Emotional health related quality of life	Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)	Change from baseline and to 18 months
Secondary	Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 6 months
Secondary	Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 12 months
Secondary	Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 18 months
Secondary	Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	6 months
Secondary	Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	12 months
Secondary	Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	18 months
Secondary	Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6 months
Secondary	Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 12 months
Secondary	Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 18 months
Secondary	Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6 months
Secondary	Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 12 months
Secondary	Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 18 months
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 6 months
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 12 months
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 18 months
Secondary	Cognitive function - Perceived cognitive impairments	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Cognitive function - Perceived cognitive impairments	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments	Change from baseline and to 6 months
Secondary	Cognitive function- Perceived cognitive impairments	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments	Change from baseline and to 12 months
Secondary	Cognitive function - Perceived cognitive impairments	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments	Change from baseline and to 18 months
Secondary	Cognitive function - Impact of Perceived cognitive impairments on quality of life	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Cognitive function - Impact of Perceived cognitive impairments on quality of life	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life	Change from baseline and to 6 months
Secondary	Cognitive function - Impact of Perceived cognitive impairments on quality of life	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life	Change from baseline and to 12 months
Secondary	Cognitive function - Impact of Perceived cognitive impairments on quality of life	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life	Change from baseline and to 18 months
Secondary	Cognitive function - Perceived cognitive abilities	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Cognitive function - Perceived cognitive abilities	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities	Change from baseline and to 6 months
Secondary	Cognitive function - Perceived cognitive abilities	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities	Change from baseline and to 12 months
Secondary	Cognitive function - Perceived cognitive abilities	Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities	Change from baseline and to 18 months
Secondary	Need for support	Single self-developed items	Change from baseline and to 6,12,18 months (mixed models)
Secondary	Need for support	Single self-developed items	Change from baseline and to 6 months
Secondary	Need for support	Single self-developed items	Change from baseline and to 12 months
Secondary	Need for support	Single self-developed items	Change from baseline and to 18 months
Secondary	Health care costs	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	Cumulative from baseline to 18 months
Secondary	Acceptability	Single self-developed items	18 months