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Rehabilitation After Breast Cancer (REBECCA II)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individually tailored nurse navigation
Sponsored by
Danish Cancer Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Psychosocial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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,

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Individually tailored nurse navigation

Usual care

Outcomes

Primary Outcome Measures

Distress
Distress Thermometer

Secondary Outcome Measures

Distress
Distress Thermometer
Distress
Distress Thermometer
Distress
Distress Thermometer
Depression
The Patient Health Questionnaire (PHQ9)
Depression
The Patient Health Questionnaire (PHQ9)
Depression
The Patient Health Questionnaire (PHQ9)
Depression
The Patient Health Questionnaire (PHQ9)
Anxiety
Generalized Anxiety Disorder (GAD7)
Anxiety
Generalized Anxiety Disorder (GAD7)
Anxiety
Generalized Anxiety Disorder (GAD7)
Anxiety
Generalized Anxiety Disorder (GAD7)
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)
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)
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)
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)
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Self-efficacy
Patient Activation Measure (PAM)
Self-efficacy
Patient Activation Measure (PAM)
Self-efficacy
Patient Activation Measure (PAM)
Self-efficacy
Patient Activation Measure (PAM)
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Cognitive function - Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Cognitive function - Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Cognitive function- Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Cognitive function - Perceived cognitive impairments
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
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
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
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
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
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Need for support
Single self-developed items
Need for support
Single self-developed items
Need for support
Single self-developed items
Need for support
Single self-developed items
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
Acceptability
Single self-developed items

Full Information

First Posted
July 31, 2017
Last Updated
August 26, 2021
Sponsor
Danish Cancer Society
Collaborators
Rigshospitalet, Denmark, Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT03254875
Brief Title
Rehabilitation After Breast Cancer
Acronym
REBECCA II
Official Title
Individually Tailored Rehabilitation After Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Cancer Society
Collaborators
Rigshospitalet, Denmark, Copenhagen University Hospital at Herlev

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Psychosocial intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Intervention status will be blinded in analyses.
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille Bidstrup, PhD
Organizational Affiliation
Danish Cancer Society Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoffer Johansen, DMSc
Organizational Affiliation
Rigshispitalet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgitte Mertz, RN
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Rehabilitation After Breast Cancer

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