Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients

January 3, 2018 updated by: Anu Toija, University of Jyvaskyla

Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Seriously sick people need social support to maintain their quality of life. Social support may be given by peers, who have experienced the same.

In this study voluntary participants with recently diagnosed breast cancer were randomly allocated to intervention (N=130) or control (N=130) group. The intervention group received, in addition to usual care, peer support via telephone 1-5 times according to their own preference. The control group received usual care only. Peer support was given by volunteered breast cancer survivors who were educated for giving peer support.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
Peer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change of health-related quality of life (HRQoL).
Time Frame: From baseline to 3, 6 and 12 months later.
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).
Time Frame: From baseline to 3, 6 and 12 months later.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction for life
Time Frame: Baseline and 3, 6 and 12 months later.
Satisfaction for life was assessed with a questionnaire created for this study.
Baseline and 3, 6 and 12 months later.
The use of health care services
Time Frame: Baseline and 3, 6 and 12 months later.
The use of health care services was assessed with a questionnaire create for this study.
Baseline and 3, 6 and 12 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jyvaskyla

Collaborators

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Anu Toija, MHS, University of Jyväskylä

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

October 30, 2016

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effectiveness of peer support

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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