REBECCA - Research in Rehabilitation After Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.

Detailed Description
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In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.

Official Title
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Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms

Conditions
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Anxiety, Depression, Adverse Effects, Health Behavior

Intervention / Treatment
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* Other: Screening-based nurse navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark lives in Copenhagen municipality score ≥7 on distress thermometer able to read and understand Danish not pregnant expected survival more than 6 months physically able to participate in rehabilitation no severe psychiatric disease demanding treatment no severe cognitive problems (e.g. dementia or confusion)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening-based nurse navigation<br>Based on systematic screening for psychological and physical symptoms as well as health behavior a nurse navigator will refer to and monitor use of appropriate rehabilitation programs | Other: Screening-based nurse navigation<br>* Screening-based nurse navigation for breast cancer rehabilitation<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress | Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Difference in change in patient reported health related quality of life between patients in the intervention and control group. Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales. | 6 and 12 months | 
| Anxiety and depression | Difference in change in patient reported anxiety and depression between patients in the intervention and control group. Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS). | 6 and 12 months | 
| Smoking | Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group. | 6 and 12 months | 
| Alcohol consumption | Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group. | 6 and 12 months | 
| Body mass index | Difference in change in patient reported body masss index between patients in intervention and control group. | 6 and 12 months | 
| Physical activity | Difference in change in patient reported physical activity between patients in intervention and control group. | 6 and 12 months | 
| Use of rehabilitation services | Difference in change in patient reported use of rehabilitation services between patients in intervention and control group. | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, anxiety, depression, adverse effects, health behavior, neoplasms