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Trial record 5 of 68641 for:    cancer

Rehabilitation After Breast Cancer (REBECCA II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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
Breast Cancer Behavioral: Individually tailored nurse navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
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
Official Title: Individually Tailored Rehabilitation After Breast Cancer
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Distress [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
    Distress Thermometer


Secondary Outcome Measures :
  1. Distress [ Time Frame: Change from baseline to 6 months ]
    Distress Thermometer

  2. Distress [ Time Frame: Change from baseline to 12 months ]
    Distress Thermometer

  3. Distress [ Time Frame: Change from baseline to 18 months ]
    Distress Thermometer

  4. Depression [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
    The Patient Health Questionnaire (PHQ9)

  5. Depression [ Time Frame: Change from baseline and to 6 months ]
    The Patient Health Questionnaire (PHQ9)

  6. Depression [ Time Frame: Change from baseline and to 12 months ]
    The Patient Health Questionnaire (PHQ9)

  7. Depression [ Time Frame: Change from baseline and to 18 months ]
    The Patient Health Questionnaire (PHQ9)

  8. Anxiety [ Time Frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) ]
    Generalized Anxiety Disorder (GAD7)

  9. Anxiety [ Time Frame: Change from baseline and to 6 months ]
    Generalized Anxiety Disorder (GAD7)

  10. Anxiety [ Time Frame: Change from baseline and to 12 months ]
    Generalized Anxiety Disorder (GAD7)

  11. Anxiety [ Time Frame: Change from baseline and to 18 months ]
    Generalized Anxiety Disorder (GAD7)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. Self-efficacy [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Patient Activation Measure (PAM)

  37. Self-efficacy [ Time Frame: Change from baseline and to 6 months ]
    Patient Activation Measure (PAM)

  38. Self-efficacy [ Time Frame: Change from baseline and to 12 months ]
    Patient Activation Measure (PAM)

  39. Self-efficacy [ Time Frame: Change from baseline and to 18 months ]
    Patient Activation Measure (PAM)

  40. Fear of recurrence [ Time Frame: 6 months ]
    Concerns About Recurrence Questionnaire (CARQ)

  41. Fear of recurrence [ Time Frame: 12 months ]
    Concerns About Recurrence Questionnaire (CARQ)

  42. Fear of recurrence [ Time Frame: 18 months ]
    Concerns About Recurrence Questionnaire (CARQ)

  43. 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

  44. Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 6 months ]
    Self-developed scale

  45. Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 12 months ]
    Self-developed scale

  46. Pain in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 18 months ]
    Self-developed scale

  47. 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

  48. Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 6 months ]
    Self-developed scale

  49. Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 12 months ]
    Self-developed scale

  50. Neuropathy in the breast surgery area (side of chest, armpit or arm) [ Time Frame: Change from baseline and to 18 months ]
    Self-developed scale

  51. Sleep quality [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Pittsburgh Sleep Quality Index (PSQI)

  52. Sleep quality [ Time Frame: Change from baseline and to 6 months ]
    Pittsburgh Sleep Quality Index (PSQI)

  53. Sleep quality [ Time Frame: Change from baseline and to 12 months ]
    Pittsburgh Sleep Quality Index (PSQI)

  54. Sleep quality [ Time Frame: Change from baseline and to 18 months ]
    Pittsburgh Sleep Quality Index (PSQI)

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. Need for support [ Time Frame: Change from baseline and to 6,12,18 months (mixed models) ]
    Single self-developed items

  68. Need for support [ Time Frame: Change from baseline and to 6 months ]
    Single self-developed items

  69. Need for support [ Time Frame: Change from baseline and to 12 months ]
    Single self-developed items

  70. Need for support [ Time Frame: Change from baseline and to 18 months ]
    Single self-developed items

  71. 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

  72. Acceptability [ Time Frame: 18 months ]
    Single self-developed items


Other Outcome Measures:
  1. Social support [ Time Frame: Baseline ]
    Modified Medical Outcomes Study Social Support Scale (MOS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254875


Contacts
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Contact: Pernille Bidstrup, PhD +45 35257600 pernille@cancer.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Christoffer Johansen, MD, PhD    +4535257627    christof@cancer.dk   
Contact: Birgitte G Mertz, RN    +45 35458432    birgitte.mertz@regionh.dk   
Sponsors and Collaborators
Danish Cancer Society
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Pernille Bidstrup, PhD Danish Cancer Society Research Center
Principal Investigator: Christoffer Johansen, DMSc Rigshispitalet
Study Chair: Birgitte Mertz, RN Rigshospitalet, Denmark

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Responsible Party: Christoffer Johansen, Professor, DMSc, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT03254875     History of Changes
Other Study ID Numbers: REBECCA II
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christoffer Johansen, Danish Cancer Society:
Breast cancer, Psychosocial intervention

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases