Breast CancerNCT01555645
Stress Management in Breast Cancer Patients
A study testing Stress management, in two steps in people with Breast Cancer and Stress, run by Uppsala University at 3 sites in Sweden.
Trial summary
The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by 1. Studying the prevalence of stress related symptoms in female patients with breast cancer 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Stress
- What is being tested?
- Stress management, in two steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 3 sitesSweden
- Study dates
- May 2009to Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 18
- a recent diagnosis of breast cancer
- scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)
Who cannot join
- ongoing psychiatric condition
- language deficiencies in Swedish
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by
- Studying the prevalence of stress related symptoms in female patients with breast cancer
- Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
- Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
- Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.
The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.
- Conditions
- Breast Cancer, Stress
- Being tested
- Stress management, in two steps
- Keywords
- Breast cancer, Stress management, Stepped care, Randomized
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress management, in two stepsBehavioural
All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.
| Study group | Role | What they receive |
|---|---|---|
| Stress management Individual format | Experimental | The methods and techniques will be the same as those used in the group intervention. The first session will be used for a detailed assessment of the individual's psychosocial problems, as used in earlier studies. The sessions will last 45 - 60 minutes. The number of sessions will depend on the individual patient's problems and the joint assessment made by the patient and nurse together. The total number of sessions will be at least 4, with a maximum of 8. The contents of the sessions are Session 1: Assessment, Session 2: Analysis of diary (self-registration) and suggestions for problem management, Session 3: Evaluation of problem management skills Session 4: Follow-up and conclusion of the intervention. When necessary Sessions 5 -8 will address specific obstacles and continued practice. Receives: Behavioral: Stress management, in two steps |
| Stress management Group format | Experimental | Participants will meet for 2 hours every week for a total of 20 hours. In the intervals between the group meetings patients will be asked to do homework. Homework entails practicing problem-solving techniques, keeping a diary, practicing relaxation or physical activities. Each group meeting has a specific subject, i.e. What is stress and stress behaviors, Stress related symptoms, How to manage anger and negative thoughts, Self-registrations and behavioral changes, Future perspectives, Cancer, stress and relations, Expectations and demands, Body, pleasure and sexuality. Receives: Behavioral: Stress management, in two steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial aspect
Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress
Measured: Changes in psychosocial aspects from baseline to 12 months post diagnosis
Secondary outcomes (2)
Cost-Utility Analysis
Measured: 12 month
Patient satisfaction
Measured: 3 month, after intensive intervention and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Nordin, Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555645
- Sponsor's protocol ID
- K2010-70X-21412-01-3
- Other IDs
- CAN 2009/25, CAN 2011/08
- Status last verified
- Dec 2015
- First submitted
- 28 Feb 2012
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hellerstedt-Borjesson S, Nordin K, Fjallskog ML, Holmstrom IK, Arving C. Women Treated for Breast Cancer Experiences of Chemotherapy-Induced Pain: Memories, Any Present Pain, and Future Reflections. Cancer Nurs. 2016 Nov/Dec;39(6):464-472. doi: 10.1097/NCC.0000000000000322.
PubMed 26632880Nordin K, Rissanen R, Ahlgren J, Burell G, Fjallskog ML, Borjesson S, Arving C. Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care. BMC Cancer. 2012 May 4;12:167. doi: 10.1186/1471-2407-12-167.
PubMed 22559200
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
- ClinicalTrials.gov ID
- NCT01555645
- Acronym / sponsor ID
- K2010-70X-21412-01-3
- Conditions
- Breast Cancer, Stress
- Keywords
- Breast cancer, Stress management, Stepped care, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Mar 2012 (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.
The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by
- Studying the prevalence of stress related symptoms in female patients with breast cancer
- Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
- Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
- Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.
The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress management Individual format | Experimental | Behavioral: Stress management, in two stepsThe methods and techniques will be the same as those used in the group intervention. The first session will be used for a detailed assessment of the individual's psychosocial problems, as used in earlier studies. The sessions will last 45 - 60 minutes. The number of sessions will depend on the individual patient's problems and the joint assessment made by the patient and nurse together. The total number of sessions will be at least 4, with a maximum of 8. The contents of the sessions are Session 1: Assessment, Session 2: Analysis of diary (self-registration) and suggestions for problem management, Session 3: Evaluation of problem management skills Session 4: Follow-up and conclusion of the intervention. When necessary Sessions 5 -8 will address specific obstacles and continued practice. |
| Stress management Group format | Experimental | Behavioral: Stress management, in two stepsParticipants will meet for 2 hours every week for a total of 20 hours. In the intervals between the group meetings patients will be asked to do homework. Homework entails practicing problem-solving techniques, keeping a diary, practicing relaxation or physical activities. Each group meeting has a specific subject, i.e. What is stress and stress behaviors, Stress related symptoms, How to manage anger and negative thoughts, Self-registrations and behavioral changes, Future perspectives, Cancer, stress and relations, Expectations and demands, Body, pleasure and sexuality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over the age of 18
- a recent diagnosis of breast cancer
- scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)
Key exclusion criteria (2 listed)
- ongoing psychiatric condition
- language deficiencies in Swedish
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 |
|---|---|---|
| Stress management, in two stepsAll patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy. | Behavioural | Stress management Group format, Stress management Individual format |
Primary outcome
Psychosocial aspect
Time frame: Changes in psychosocial aspects from baseline to 12 months post diagnosis
Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress
2 secondary outcomes
Cost-Utility Analysis
Time frame: 12 month
Patient satisfaction
Time frame: 3 month, after intensive intervention and 12 month
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 4 Dec 2015.
- Derived from this study: PubMed 26632880Hellerstedt-Borjesson S, Nordin K, Fjallskog ML, Holmstrom IK, Arving C. Women Treated for Breast Cancer Experiences of Chemotherapy-Induced Pain: Memories, Any Present Pain, and Future Reflections. Cancer Nurs. 2016 Nov/Dec;39(6):464-472. doi: 10.1097/NCC.0000000000000322.
- Derived from this study: PubMed 22559200Nordin K, Rissanen R, Ahlgren J, Burell G, Fjallskog ML, Borjesson S, Arving C. Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care. BMC Cancer. 2012 May 4;12:167. doi: 10.1186/1471-2407-12-167.
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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.
Karin Nordin, Prof principal investigator
Uppsala University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress management, in two steps in people with Breast Cancer and Stress, run by Uppsala University at 3 sites in Sweden.
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 3 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Psychosocial aspect (time frame: Changes in psychosocial aspects from baseline to 12 months post diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01555645, which also lists 2 linked publications.
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 4 Dec 2015.