Breast CancerNCT00289432
Hospital Based Group Intervention for Breast Cancer Patients.
A study testing Psychoeducative and Support group in people with Breast Cancer and Anxiety, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Anxiety, Depression
- What is being tested?
- Psychoeducative and Support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2006to Dec 2014
- 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 18 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Verified breast cancer diagnosis Age 18 years or more but under 75 years -
Who cannot join
- Diagnoses of metastatic breast cancer Do not read or write Norwegian Diagnoses of mental retardation, severe or untreated psychopathology, dementia Diagnoses of any immunologic condition or disease
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study.
INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care. The hypotheses are; - that breast cancer patients participating in psychoeducative interventions focusing on coping will experience better health-related quality of life than those who participate in the hospital standardised psychoeducative intervention. - that coping styles are associated with the immune system.
Read the detailed description
Women operated for breast cancer often experience psychosocial problems for several years. Although, meta-analyses have clearly demonstrated that the efficacy of psychosocial support groups, little is known about the effectiveness of this intervention when offered in the hospital setting as a component of routine breast cancer care.
A few studies have found that psychological intervention reduce emotional distress and enhance immune responses,but if there is an association between coping styles and immune system is not clear.
440 breast cancer patients at two Hospital will be randomized into the study. Both Hospital have standardised psychoeducative interventions as a component of routine breast cancer care. Both Hospital will have two groups, the standardised groups and the experimental groups. Participants will answer the same standardised questionnaires before surgery,2,6,12 months and 3 and 5 years after the interventions. Blood sample will be drawn at all assessments. The questionnaires are the Hospital Anxiety and Depression Scale, the Mini-mental Adjustment to Cancer Scale, the EORTC QLQ-BR32, the Life Orientation Test-Revised.
All groups are facilitated by two nurse specialists and follow a structured program. The standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session. The intervention protocol has been approved by the Norwegian Committee for medical research Ethics.
Knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients.
- Conditions
- Breast Cancer, Anxiety, Depression, Quality of Life, Coping
- Being tested
- Psychoeducative, Support group
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducativeBehavioural
Also called Intervention group
The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment
Support groupOther
Also called Standard group
Standard Hospital follow-up support group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral: Psychoeducative intervention Receives: Behavioral: Psychoeducative |
| 2 | Active comparator | The Hospitals standard follow-up support group Receives: Other: Support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on Health-related quality of life
Measured: 2, 6 12 months and at 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2009
- Study completionDec 2014
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Principal investigator, Inger Schou Bredal, Oslo University Hospital
- Investigators
- Inger Schou Bredal, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289432
- Sponsor's protocol ID
- INCAM
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2006
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study.
- ClinicalTrials.gov ID
- NCT00289432
- Acronym / sponsor ID
- INCAM
- Conditions
- Breast Cancer, Anxiety, Depression, Quality of Life, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Apr 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Feb 2006 (estimated)
- 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.
INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care. The hypotheses are; - that breast cancer patients participating in psychoeducative interventions focusing on coping will experience better health-related quality of life than those who participate in the hospital standardised psychoeducative intervention. - that coping styles are associated with the immune system.
Detailed description
Women operated for breast cancer often experience psychosocial problems for several years. Although, meta-analyses have clearly demonstrated that the efficacy of psychosocial support groups, little is known about the effectiveness of this intervention when offered in the hospital setting as a component of routine breast cancer care.
A few studies have found that psychological intervention reduce emotional distress and enhance immune responses,but if there is an association between coping styles and immune system is not clear.
440 breast cancer patients at two Hospital will be randomized into the study. Both Hospital have standardised psychoeducative interventions as a component of routine breast cancer care. Both Hospital will have two groups, the standardised groups and the experimental groups. Participants will answer the same standardised questionnaires before surgery,2,6,12 months and 3 and 5 years after the interventions. Blood sample will be drawn at all assessments. The questionnaires are the Hospital Anxiety and Depression Scale, the Mini-mental Adjustment to Cancer Scale, the EORTC QLQ-BR32, the Life Orientation Test-Revised.
All groups are facilitated by two nurse specialists and follow a structured program. The standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session. The intervention protocol has been approved by the Norwegian Committee for medical research Ethics.
Knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: PsychoeducativeBehavioral: Psychoeducative intervention |
| 2 | Active comparator | Other: Support groupThe Hospitals standard follow-up support group |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Verified breast cancer diagnosis Age 18 years or more but under 75 years -
Key exclusion criteria (2 listed)
- Diagnoses of metastatic breast cancer Do not read or write Norwegian Diagnoses of mental retardation, severe or untreated psychopathology, dementia Diagnoses of any immunologic condition or disease
- -
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 |
|---|---|---|
| PsychoeducativeAlso: Intervention groupThe experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment | Behavioural | 1 |
| Support groupAlso: Standard groupStandard Hospital follow-up support group | Other | 2 |
Primary outcome
Scores on Health-related quality of life
Time frame: 2, 6 12 months and at 3 and 5 years
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 30 Apr 2015.
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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.
Inger Schou Bredal, PhD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducative and Support group in people with Breast Cancer and Anxiety, run by Ullevaal University Hospital at 1 site in Norway.
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 1 inclusion and 2 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 30 Apr 2015. 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 Norway. 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?
Scores on Health-related quality of life (time frame: 2, 6 12 months and at 3 and 5 years). 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 30 Apr 2015.