Breast CancerNCT03394742
Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients
A study testing Peer support in people with Breast Cancer, run by University of Jyvaskyla at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2014to 30 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- some other serious illnesses
- inability to communicate in Finnish or Swedish (official languages in Finland)
- inability to fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Peer support
- Keywords
- Peer Group, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportBehavioural
Peer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Peer support |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
A change of health-related quality of life (HRQoL).
HRQoL was assessed with a generic 15D instrument.
Measured: From baseline to 3, 6 and 12 months later.
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.
Measured: From baseline to 3, 6 and 12 months later.
Secondary outcomes (2)
Satisfaction for life
Satisfaction for life was assessed with a questionnaire created for this study.
Measured: Baseline and 3, 6 and 12 months later.
The use of health care services
The use of health care services was assessed with a questionnaire create for this study.
Measured: Baseline and 3, 6 and 12 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 May 2014
- Primary completion30 Jun 2015
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Anu Toija, University of Jyvaskyla
- Investigators
- Anu Toija, MHS, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394742
- Sponsor's protocol ID
- Effectiveness of peer support
- Status last verified
- Jan 2018
- First submitted
- 20 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial
- ClinicalTrials.gov ID
- NCT03394742
- Acronym / sponsor ID
- Effectiveness of peer support
- Conditions
- Breast Cancer
- Keywords
- Peer Group, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Peer supportPeer 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. |
| Control group | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- some other serious illnesses
- inability to communicate in Finnish or Swedish (official languages in Finland)
- inability to fill in the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer supportPeer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone. | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
Satisfaction for life
Time frame: Baseline and 3, 6 and 12 months later.
The use of health care services
Time frame: Baseline and 3, 6 and 12 months later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Toija, MHS principal investigator
University of Jyvaskyla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support in people with Breast Cancer, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change of health-related quality of life (HRQoL). (time frame: From baseline to 3, 6 and 12 months later.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.