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REBECCA - Research in Rehabilitation After Breast Cancer

D

Danish Cancer Society

Status

Completed

Conditions

Adverse Effects
Health Behavior
Depression
Anxiety

Treatments

Other: Screening-based nurse navigation

Study type

Interventional

Funder types

Other

Identifiers

NCT02056483
REBECCA

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Screening-based nurse navigation
Experimental group
Description:
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
Treatment:
Other: Screening-based nurse navigation
Usual care
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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