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

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ClinicalTrials.gov Identifier: NCT03394742
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Anu Toija, University of Jyvaskyla

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Peer support Not Applicable

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  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants were women who had breast cancer.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394742


Locations
Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
University of Jyvaskyla
Helsinki University Central Hospital
Investigators
Principal Investigator: Anu Toija, MHS University of Jyvaskyla

Responsible Party: Anu Toija, Doctoral student, University of Jyvaskyla
ClinicalTrials.gov Identifier: NCT03394742     History of Changes
Other Study ID Numbers: Effectiveness of peer support
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anu Toija, University of Jyvaskyla:
Peer Group
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases