Rehabilitation After Breast Cancer (REBECCA II)

Individually Tailored Rehabilitation After Breast Cancer

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Individually tailored nurse navigation

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 Type: Interventional
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress	Distress Thermometer	Change from baseline and to 6,12 months (mixed models)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress	Distress Thermometer	Change from baseline to 6 months
Distress	Distress Thermometer	Change from baseline to 12 months
Distress	Distress Thermometer	Change from baseline to 18 months
Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 6 months
Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 12 months
Depression	The Patient Health Questionnaire (PHQ9)	Change from baseline and to 18 months
Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 6 months
Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 12 months
Anxiety	Generalized Anxiety Disorder (GAD7)	Change from baseline and to 18 months
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 6,12,18 months (mixed models)
Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 6 months
Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 12 months
Self-efficacy	Patient Activation Measure (PAM)	Change from baseline and to 18 months
Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	6 months
Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	12 months
Fear of recurrence	Concerns About Recurrence Questionnaire (CARQ)	18 months
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)
Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6 months
Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 12 months
Pain in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 18 months
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)
Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 6 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 12 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)	Self-developed scale	Change from baseline and to 18 months
Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 6,12,18 months (mixed models)
Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 6 months
Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 12 months
Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Change from baseline and to 18 months
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)
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
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
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
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)
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
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
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
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)
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
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
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
Need for support	Single self-developed items	Change from baseline and to 6,12,18 months (mixed models)
Need for support	Single self-developed items	Change from baseline and to 6 months
Need for support	Single self-developed items	Change from baseline and to 12 months
Need for support	Single self-developed items	Change from baseline and to 18 months
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
Acceptability	Single self-developed items	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social support	Modified Medical Outcomes Study Social Support Scale (MOS)	Baseline

Collaborators and Investigators

• Sponsor: Danish Cancer Society
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer, Psychosocial intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: REBECCA II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No