Stress Management in Breast Cancer Patients
3. desember 2015 oppdatert av: Uppsala University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
466
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Falun, Sverige
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Gävle, Sverige
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Uppsala, Sverige
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- over the age of 18
- a recent diagnosis of breast cancer
- scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)
Exclusion Criteria:
- ongoing psychiatric condition
- language deficiencies in Swedish
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Stress management Individual format
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.
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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.
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Eksperimentell: Stress management Group format
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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Psychosocial aspect
Tidsramme: Changes in psychosocial aspects from baseline to 12 months post diagnosis
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Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress
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Changes in psychosocial aspects from baseline to 12 months post diagnosis
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Cost-Utility Analysis
Tidsramme: 12 month
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12 month
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Patient satisfaction
Tidsramme: 3 month, after intensive intervention and 12 month
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3 month, after intensive intervention and 12 month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Karin Nordin, Prof, Uppsala University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Nordin 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2009
Primær fullføring (Faktiske)
1. mars 2014
Studiet fullført (Faktiske)
1. september 2014
Datoer for studieregistrering
Først innsendt
28. februar 2012
Først innsendt som oppfylte QC-kriteriene
14. mars 2012
Først lagt ut (Anslag)
15. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K2010-70X-21412-01-3
- CAN 2009/25 (Annet stipend/finansieringsnummer: the Swedish Cancer Society)
- CAN 2011/08 (Annet stipend/finansieringsnummer: the Swedish Cancer Society)
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