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Trial record 5 of 69131 for:    cancer

Rehabilitation After Breast Cancer (REBECCA II)

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ClinicalTrials.gov Identifier: NCT03254875
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Christoffer Johansen, Danish Cancer Society

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 21, 2017
Last Update Posted Date August 21, 2017
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
Distress [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
Distress Thermometer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
  • Distress [ Time Frame: Change from baseline to 6 months ]
    Distress Thermometer
  • Distress [ Time Frame: Change from baseline to 12 months ]
    Distress Thermometer
  • Distress [ Time Frame: Change from baseline to 18 months ]
    Distress Thermometer
  • Depression [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
    The Patient Health Questionnaire (PHQ9)
  • Depression [ Time Frame: Change from baseline and to 6 months ]
    The Patient Health Questionnaire (PHQ9)
  • Depression [ Time Frame: Change from baseline and to 12 months ]
    The Patient Health Questionnaire (PHQ9)
  • Depression [ Time Frame: Change from baseline and to 18 months ]
    The Patient Health Questionnaire (PHQ9)
  • Anxiety [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
    Generalized Anxiety Disorder (GAD7)
  • Anxiety [ Time Frame: Change from baseline and to 6 months ]
    Generalized Anxiety Disorder (GAD7)
  • Anxiety [ Time Frame: Change from baseline and to 12 months ]
    Generalized Anxiety Disorder (GAD7)
  • Anxiety [ Time Frame: Change from baseline and to 18 months ]
    Generalized Anxiety Disorder (GAD7)
  • Health related quality of life summary index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline and to 18 months ]
    Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
  • Self-efficacy [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Patient Activation Measure (PAM)
  • Self-efficacy [ Time Frame: Change from baseline and to 6 months ]
    Patient Activation Measure (PAM)
  • Self-efficacy [ Time Frame: Change from baseline and to 12 months ]
    Patient Activation Measure (PAM)
  • Self-efficacy [ Time Frame: Change from baseline and to 18 months ]
    Patient Activation Measure (PAM)
  • Fear of recurrence [ Time Frame: 6 months ]
    Concerns About Recurrence Questionnaire (CARQ)
  • Fear of recurrence [ Time Frame: 12 months ]
    Concerns About Recurrence Questionnaire (CARQ)
  • Fear of recurrence [ Time Frame: 18 months ]
    Concerns About Recurrence Questionnaire (CARQ)
  • Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: 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) [ Time Frame: Change from baseline and to 6 months ]
    Self-developed scale
  • Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 12 months ]
    Self-developed scale
  • Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 18 months ]
    Self-developed scale
  • Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: 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) [ Time Frame: Change from baseline and to 6 months ]
    Self-developed scale
  • Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 12 months ]
    Self-developed scale
  • Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 18 months ]
    Self-developed scale
  • Sleep quality [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Sleep quality [ Time Frame: Change from baseline and to 6 months ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Sleep quality [ Time Frame: Change from baseline and to 12 months ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Sleep quality [ Time Frame: Change from baseline and to 18 months ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Cognitive function - Perceived cognitive impairments [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Single self-developed items
  • Need for support [ Time Frame: Change from baseline and to 6 months ]
    Single self-developed items
  • Need for support [ Time Frame: Change from baseline and to 12 months ]
    Single self-developed items
  • Need for support [ Time Frame: Change from baseline and to 18 months ]
    Single self-developed items
  • Health care costs [ Time Frame: 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 [ Time Frame: 18 months ]
    Single self-developed items
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 16, 2017)
Social support [ Time Frame: Baseline ]
Modified Medical Outcomes Study Social Support Scale (MOS)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Rehabilitation After Breast Cancer
Official Title  ICMJE Individually Tailored Rehabilitation After Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description:
Intervention status will be blinded in analyses.
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Individually tailored nurse navigation
    Intervention: Behavioral: Individually tailored nurse navigation
  • No Intervention: Control
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2017)
324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pernille Bidstrup, PhD +45 35257600 pernille@cancer.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03254875
Other Study ID Numbers  ICMJE REBECCA II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christoffer Johansen, Danish Cancer Society
Study Sponsor  ICMJE Danish Cancer Society
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Copenhagen University Hospital at Herlev
Investigators  ICMJE
Principal Investigator: Pernille Bidstrup, PhD Danish Cancer Society Research Center
Principal Investigator: Christoffer Johansen, DMSc Rigshispitalet
Study Chair: Birgitte Mertz, RN Rigshospitalet, Denmark
PRS Account Danish Cancer Society
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP