REBECCA - Research in Rehabilitation After Breast Cancer

Not Applicable

Completed

• Conditions: Health Behavior; Depression; Adverse Effects; Anxiety
• Interventions: Other: Screening-based nurse navigation

• Registration Number: NCT02056483
• Lead Sponsor: Danish Cancer Society

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening-based nurse navigation	Screening-based nurse navigation	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

Primary Outcome Measures

Name	Time	Method
Psychological distress	6 and 12 months	Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	6 and 12 months	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.
Anxiety and depression	6 and 12 months	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).
Smoking	6 and 12 months	Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
Alcohol consumption	6 and 12 months	Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
Body mass index	6 and 12 months	Difference in change in patient reported body masss index between patients in intervention and control group.
Physical activity	6 and 12 months	Difference in change in patient reported physical activity between patients in intervention and control group.
Use of rehabilitation services	6 and 12 months	Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark