- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394742
Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients
Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland, 00029
- Helsinki University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Peer support persons are breast cancer survivors, who were educated to give peer support.
They contacted participants by telephone.
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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.
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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.
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HRQoL was assessed with a generic 15D instrument.
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From baseline to 3, 6 and 12 months later.
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A change of health-related quality of life (HRQoL).
Time Frame: From baseline to 3, 6 and 12 months later.
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HRQoL was assessed with a disease-specific instrument EORTC QLQ-30 and its breast cancer specific module BR23.
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From baseline to 3, 6 and 12 months later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction for life
Time Frame: Baseline and 3, 6 and 12 months later.
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Satisfaction for life was assessed with a questionnaire created for this study.
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Baseline and 3, 6 and 12 months later.
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The use of health care services
Time Frame: Baseline and 3, 6 and 12 months later.
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The use of health care services was assessed with a questionnaire create for this study.
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Baseline and 3, 6 and 12 months later.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anu Toija, MHS, University of Jyväskylä
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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