Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT03394742|
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Peer support||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||June 30, 2015|
|Actual Study Completion Date :||October 30, 2016|
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394742
|Helsinki University Hospital|
|Helsinki, Finland, 00029|
|Principal Investigator:||Anu Toija, MHS||University of Jyvaskyla|