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Completed

NCT Number: NCT02056483

REBECCA - Research in Rehabilitation After Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Screening-based nurse navigation

Other

Screening-based nurse navigation for breast cancer rehabilitation

Primary outcomes

  1. Psychological distress

    Time frame: 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 outcomes

  1. Health related quality of life

    Time frame: 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.

  2. Anxiety and depression

    Time frame: 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).

  3. Smoking

    Time frame: 6 and 12 months

    Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.

  4. Alcohol consumption

    Time frame: 6 and 12 months

    Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.

  5. Body mass index

    Time frame: 6 and 12 months

    Difference in change in patient reported body masss index between patients in intervention and control group.

  6. Physical activity

    Time frame: 6 and 12 months

    Difference in change in patient reported physical activity between patients in intervention and control group.

  7. Use of rehabilitation services

    Time frame: 6 and 12 months

    Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Center for Kræft og Sundhed
  • Rigshospitalet, Denmark
  • TRYG Foundation

Registry information

Official study title

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

Acronym: REBECCA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2014
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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