Clinical trial NCT02056483: REBECCA - Research in Rehabilitation After Breast Cancer
Official title: Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Adverse Effects
Health Behavior
Keywords: neoplasms
rehabilitation
anxiety
depression
adverse effects
health behavior
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
name: Rigshospitalet, Denmark
name: Center for Kræft og Sundhed
First posted: 2014-02-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Psychological distress
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: 6 and 12 months
measure: Anxiety and depression
timeFrame: 6 and 12 months
measure: Smoking
timeFrame: 6 and 12 months
measure: Alcohol consumption
timeFrame: 6 and 12 months
measure: Body mass index
timeFrame: 6 and 12 months
measure: Physical activity
timeFrame: 6 and 12 months
measure: Use of rehabilitation services
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Danish Cancer Society
name: Christoffer Johansen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Cancer Society
name: Pernille E Bidstrup, MA. PhD
role: PRINCIPAL_INVESTIGATOR
References: