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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Peer support
Sponsored by
University of Jyvaskyla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Peer Group, Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

A change of health-related quality of life (HRQoL).
HRQoL was assessed with a generic 15D instrument.
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.

Secondary Outcome Measures

Satisfaction for life
Satisfaction for life was assessed with a questionnaire created for this study.
The use of health care services
The use of health care services was assessed with a questionnaire create for this study.

Full Information

First Posted
December 20, 2017
Last Updated
January 3, 2018
Sponsor
University of Jyvaskyla
Collaborators
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03394742
Brief Title
Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients
Official Title
Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
October 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jyvaskyla
Collaborators
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Peer Group, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer support
Intervention Description
Peer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone.
Primary Outcome Measure Information:
Title
A change of health-related quality of life (HRQoL).
Description
HRQoL was assessed with a generic 15D instrument.
Time Frame
From baseline to 3, 6 and 12 months later.
Title
A change of health-related quality of life (HRQoL).
Description
HRQoL was assessed with a disease-specific instrument EORTC QLQ-30 and its breast cancer specific module BR23.
Time Frame
From baseline to 3, 6 and 12 months later.
Secondary Outcome Measure Information:
Title
Satisfaction for life
Description
Satisfaction for life was assessed with a questionnaire created for this study.
Time Frame
Baseline and 3, 6 and 12 months later.
Title
The use of health care services
Description
The use of health care services was assessed with a questionnaire create for this study.
Time Frame
Baseline and 3, 6 and 12 months later.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants were women who had breast cancer.
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Toija, MHS
Organizational Affiliation
University of Jyvaskyla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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