NCT03394742

Brief Summary

This study examines effectiveness of peer support of breast cancer patients. Half of the participants received peer support via telephone in addition to usual care and another half are give the usual care only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

December 20, 2017

Last Update Submit

January 3, 2018

Conditions

Keywords

Peer GroupQuality of Life

Outcome Measures

Primary Outcomes (2)

  • A change of health-related quality of life (HRQoL).

    HRQoL was assessed with a generic 15D instrument.

    From baseline to 3, 6 and 12 months later.

  • A change of health-related quality of life (HRQoL).

    HRQoL was assessed with a disease-specific instrument EORTC QLQ-30 and its breast cancer specific module BR23.

    From baseline to 3, 6 and 12 months later.

Secondary Outcomes (2)

  • Satisfaction for life

    Baseline and 3, 6 and 12 months later.

  • The use of health care services

    Baseline and 3, 6 and 12 months later.

Study Arms (2)

Intervention group

EXPERIMENTAL

Peer support group received, in addition to usual care, peer support via telephone 1-5 times according to their own preference. Peer support was started at the time between diagnosis and the beginning of treatments.

Behavioral: Peer support

Control group

NO INTERVENTION

The control group received usual care only. For ethical reasons, participants in the control group were not discouraged from seeking peer support by themselves if they felt a need for it.

Interventions

Peer supportBEHAVIORAL

Peer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone.

Intervention group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants were women who had breast cancer.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • recently diagnosed primary breast cancer
  • no other serious illnesses
  • ability to communicate in Finnish or Swedish (official languages in Finland)
  • ability to fill in the questionnaires

You may not qualify if:

  • some other serious illnesses
  • inability to communicate in Finnish or Swedish (official languages in Finland)
  • inability to fill in the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anu Toija, MHS

    University of Jyvaskyla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 9, 2018

Study Start

May 1, 2014

Primary Completion

June 30, 2015

Study Completion

October 30, 2016

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations