Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care

Karin Nordin, Ritva Rissanen, Johan Ahlgren, Gunilla Burell, Marie-Louise Fjällskog, Susanne Börjesson, Cecilia Arving, Karin Nordin, Ritva Rissanen, Johan Ahlgren, Gunilla Burell, Marie-Louise Fjällskog, Susanne Börjesson, Cecilia Arving

Abstract

Background: A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design.

Method: Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated.

Discussion: This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients' quality of life and psychological well-being.

Trial registration: ClinicalTrials.gov Identifier: NCT01555645.

Figures

Figure 1
Figure 1
Study design.

References

    1. Smith MY, Redd WH, Peyser C. et -traumatic stress disorder in cancer: a review. Psychooncology. 1999;8:521–537. doi: 10.1002/(SICI)1099-1611(199911/12)8:6<521::AID-PON423>;2-X.
    1. Nordin K, Glimelius B. Predicting delayed anxiety and depression in patients with gastrointestinal cancer. Br J Cancer. 1999;79:525–529. doi: 10.1038/sj.bjc.6690082.
    1. Korinek V, Barker N, Morin PJ, van Wichen D, de Weger R, Kinzler KW, Vogelstein B, Clevers H. Constitutive transcriptional activation by a beta-catenin-Tcf complex in APC−/− colon carcinoma. Science. 1997;275(5307):1784–1787. doi: 10.1126/science.275.5307.1784.
    1. Groden J, Thliveris A, Samowitz W, Carlson M, Gelbert L, Albertsen H, Joslyn G, Stevens J, Spirio L, Robertson M. et al.Identification and characterization of the familial adenomatous polyposis coli gene. Cell. 1991;66(3):589–600. doi: 10.1016/0092-8674(81)90021-0.
    1. Lundberg U, Frankenhaeuser M. Stress and workload of men and women in high-ranking positions. J Occup Health Psychol. 1999;4(2):142–151.
    1. Jacobsen P, Hann D. In: Psycho-oncology. Breitbart W, Holland JC, editor. Oxford University Press, New York; Oxford; 1998. Cognitive-Behavioral Interventions; p. 1189.
    1. Galceran J, Farinas I, Depew MJ, Clevers H, Grosschedl R. Wnt3a−/−−like phenotype and limb deficiency in Lef1(−/−)Tcf1(−/−) mice. Genes Dev. 1999;13(6):709–717. doi: 10.1101/gad.13.6.709.
    1. Malanchi I, Peinado H, Kassen D, Hussenet T, Metzger D, Chambon P, Huber M, Hohl D, Cano A, Birchmeier W. et al.Cutaneous cancer stem cell maintenance is dependent on beta-catenin signalling. Nature. 2008;452(7187):650–653. doi: 10.1038/nature06835.
    1. Arving C, Sjoden PO, Bergh J. et al.Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. Cancer Nurs. 2007;30(3):E10–E19. doi: 10.1097/01.NCC.0000270709.64790.05.
    1. Hellbom M, Brandberg Y, Kurland J. et al.Assessment and treatment of psychosocial problems in cancer patients: an exploratory study of a course for nurses. Patient Educ Couns. 2001;45:101–106. doi: 10.1016/S0738-3991(00)00198-1.
    1. Arving C, Sjoden PO, Bergh J. et al.Satisfaction, utilisation and perceived benefit of individual psychosocial support for breast cancer patients–a randomised study of nurse versus psychologist interventions. Patient Educ Couns. 2006;62:235–243. doi: 10.1016/j.pec.2005.07.008.
    1. Evans PC, Taylor ER, Coadwell J, Heyninck K, Beyaert R, Kilshaw PJ. Isolation and characterization of two novel A20-like proteins. Biochem J. 2001;357(Pt 3):617–623.
    1. Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005;186:11–17. doi: 10.1192/bjp.186.1.11.
    1. Antoni MH, Wimberly SR, Lechner SC. et al.Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention among women undergoing treatment for breast cancer. Am J Psychiatry. 2006;163(10):1791–1797. doi: 10.1176/appi.ajp.163.10.1791.
    1. Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979;41:209–218.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Aaronson NK, Ahmedzai S, Bergman B. et al.The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–376. doi: 10.1093/jnci/85.5.365.
    1. Sprangers MA, Groenvold M, Arraras JI. et al.The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996;14:2756–2768.
    1. The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.
    1. Smets EM, Garssen B, Bonke B. et al.The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39(3):315–325. doi: 10.1016/0022-3999(94)00125-O.
    1. Furst CJ, Ahsberg E. Dimensions of fatigue during radiotherapy. An application of the Multidimensional Fatigue Inventory. Support Care Cancer. 2001;9(5):355–360. doi: 10.1007/s005200100242.
    1. Jacobson MP, Friesner RA, Xiang ZX, Honig B. On the role of the crystal environment in determining protein side-chain conformations. J Mol Biol. 2002;320(3):597–608. doi: 10.1016/S0022-2836(02)00470-9.
    1. DE Åsenlöf P, Lindberg P. Behavioral goal assessment in patients with persistent musculoskeletal pain. Physiotherapy Theory and Practice. 2004;20:243–254. doi: 10.1080/09593980490887957.
    1. Claesson M, Birgander LS, Jansson JH. et al.Cognitive-behavioural stress management does not improve biological cardiovascular risk indicators in women with ischaemic heart disease: a randomized-controlled trial. J Intern Med. 2006;260(4):320–331. doi: 10.1111/j.1365-2796.2006.01691.x.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa