Clinical trial NCT03254875: Rehabilitation After Breast Cancer
Official title: Individually Tailored Rehabilitation After Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer, Psychosocial intervention
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Copenhagen University Hospital at Herlev
First posted: 2017-08-21
Enrollment: 309
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: Distress
timeFrame: Change from baseline and to 6,12 months (mixed models)
Secondary outcomes:
measure: Distress
timeFrame: Change from baseline to 6 months
measure: Distress
timeFrame: Change from baseline to 12 months
measure: Distress
timeFrame: Change from baseline to 18 months
measure: Depression
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Depression
timeFrame: Change from baseline and to 6 months
measure: Depression
timeFrame: Change from baseline and to 12 months
measure: Depression
timeFrame: Change from baseline and to 18 months
measure: Anxiety
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Anxiety
timeFrame: Change from baseline and to 6 months
measure: Anxiety
timeFrame: Change from baseline and to 12 months
measure: Anxiety
timeFrame: Change from baseline and to 18 months
measure: Health related quality of life summary index
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Health related quality of life summary index
timeFrame: Change from baseline and to 6 months
measure: Health related quality of life summary index
timeFrame: Change from baseline and to 12 months
measure: Health related quality of life summary index
timeFrame: Change from baseline and to 18 months
measure: Breast cancer related quality of life summary index
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Breast cancer related quality of life summary index
timeFrame: Change from baseline and to 6 months
measure: Breast cancer related quality of life summary index
timeFrame: Change from baseline and to 12 months
measure: Breast cancer related quality of life summary index
timeFrame: Change from baseline and to 18 months
measure: Functional related quality of life summary index
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Functional related quality of life summary index
timeFrame: Change from baseline and to 6 months
measure: Functional related quality of life summary index
timeFrame: Change from baseline and to 12 months
measure: Functional related quality of life summary index
timeFrame: Change from baseline and to 18 months
measure: Physical health related quality of life
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Physical health related quality of life
timeFrame: Change from baseline and to 6 months
measure: Physical health related quality of life
timeFrame: Change from baseline and to 12 months
measure: Physical health related quality of life
timeFrame: Change from baseline and to 18 months
measure: Social health related quality of life
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Social health related quality of life
timeFrame: Change from baseline and to 6 months
measure: Social health related quality of life
timeFrame: Change from baseline and to 12 months
measure: Social health related quality of life
timeFrame: Change from baseline and to 18 months
measure: Emotional health related quality of life
timeFrame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
measure: Emotional health related quality of life
timeFrame: Change from baseline and to 6 months
measure: Emotional health related quality of life
timeFrame: Change from baseline and to 12 months
measure: Emotional health related quality of life
timeFrame: Change from baseline and to 18 months
measure: Self-efficacy
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Self-efficacy
timeFrame: Change from baseline and to 6 months
measure: Self-efficacy
timeFrame: Change from baseline and to 12 months
measure: Self-efficacy
timeFrame: Change from baseline and to 18 months
measure: Fear of recurrence
timeFrame: 6 months
measure: Fear of recurrence
timeFrame: 12 months
measure: Fear of recurrence
timeFrame: 18 months
measure: Pain in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Pain in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 6 months
measure: Pain in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 12 months
measure: Pain in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 18 months
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 6 months
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 12 months
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
timeFrame: Change from baseline and to 18 months
measure: Sleep quality
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Sleep quality
timeFrame: Change from baseline and to 6 months
measure: Sleep quality
timeFrame: Change from baseline and to 12 months
measure: Sleep quality
timeFrame: Change from baseline and to 18 months
measure: Cognitive function - Perceived cognitive impairments
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Cognitive function - Perceived cognitive impairments
timeFrame: Change from baseline and to 6 months
measure: Cognitive function- Perceived cognitive impairments
timeFrame: Change from baseline and to 12 months
measure: Cognitive function - Perceived cognitive impairments
timeFrame: Change from baseline and to 18 months
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
timeFrame: Change from baseline and to 6 months
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
timeFrame: Change from baseline and to 12 months
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
timeFrame: Change from baseline and to 18 months
measure: Cognitive function - Perceived cognitive abilities
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Cognitive function - Perceived cognitive abilities
timeFrame: Change from baseline and to 6 months
measure: Cognitive function - Perceived cognitive abilities
timeFrame: Change from baseline and to 12 months
measure: Cognitive function - Perceived cognitive abilities
timeFrame: Change from baseline and to 18 months
measure: Need for support
timeFrame: Change from baseline and to 6,12,18 months (mixed models)
measure: Need for support
timeFrame: Change from baseline and to 6 months
measure: Need for support
timeFrame: Change from baseline and to 12 months
measure: Need for support
timeFrame: Change from baseline and to 18 months
measure: Health care costs
timeFrame: Cumulative from baseline to 18 months
measure: Acceptability
timeFrame: 18 months
Other outcomes:
measure: Social support
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Danish Cancer Society Research Center
name: Pernille Bidstrup, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshispitalet
name: Christoffer Johansen, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Birgitte Mertz, RN
role: STUDY_CHAIR
References: