Skip to main content
OpenTrials
Completed

NCT Number: NCT03254875

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, DK-2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Individually tailored nurse navigation

Behavioral

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 outcomes

  1. Distress

    Time frame: Change from baseline and to 6,12 months (mixed models)

    Distress Thermometer

Secondary outcomes

  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 outcomes

  1. Social support

    Time frame: Baseline

    Modified Medical Outcomes Study Social Support Scale (MOS)

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Copenhagen University Hospital at Herlev
  • Rigshospitalet, Denmark

Registry information

Official study title

Individually Tailored Rehabilitation After Breast Cancer

Acronym: REBECCA II

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2017
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.