REBECCA - Research in Rehabilitation After Breast Cancer

Depression Clinical Trial

— REBECCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056483
• Other study ID #: REBECCA
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: August 5, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adverse Effects
• Anxiety
• Depression
• Health Behavior

Intervention

Other:
• Screening-based nurse navigation
Screening-based nurse navigation for breast cancer rehabilitation

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Danish Cancer Society	Center for Kræft og Sundhed, Rigshospitalet, Denmark, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Body mass index	Difference in change in patient reported body masss index between patients in intervention and control group.	6 and 12 months	No
Secondary	Physical activity	Difference in change in patient reported physical activity between patients in intervention and control group.	6 and 12 months	No
Secondary	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	No