Rehabilitation After Breast Cancer

NCT03254875 | Completed

• 1 other identifier: REBECCA II
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).

Conditions

Breast Cancer

Keywords

Breast cancer, Psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• Distress

  Distress Thermometer

  Change from baseline and to 6,12 months (mixed models)

Secondary Outcomes (72)

• Distress

  Change from baseline to 6 months

• Distress

  Change from baseline to 12 months

• Distress

  Change from baseline to 18 months

• Depression

  Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)

• Depression

  Change from baseline and to 6 months

Other Outcomes (1)

• Social support

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Individually tailored nurse navigation

Behavioral: Individually tailored nurse navigation

Control

NO INTERVENTION

Usual care

Interventions

Individually tailored nurse navigation BEHAVIORAL

The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score \< 7 on the distress thermometer) will be followed in an observational questionnaire study.

You may not qualify if:

• no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,

Sponsors & Collaborators

• Danish Cancer Society: lead
• Rigshospitalet, Denmark: collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

• Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591.

  PMID: 37351885 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pernille Bidstrup, PhD

  Danish Cancer Society Research Center

  PRINCIPAL INVESTIGATOR

• Christoffer Johansen, DMSc

  Rigshispitalet

  PRINCIPAL INVESTIGATOR

• Birgitte Mertz, RN

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Intervention status will be blinded in analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc

Model Details: During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 21, 2017
• Study Start: August 15, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)