Effectiveness of the "Cancer Home-Life Intervention" on everyday activities and quality of life in people with advanced cancer living at home: a randomised controlled trial and an economic evaluation

Å Brandt, M S Pilegaard, L G Oestergaard, L Lindahl-Jacobsen, J Sørensen, A T Johnsen, K la Cour, Å Brandt, M S Pilegaard, L G Oestergaard, L Lindahl-Jacobsen, J Sørensen, A T Johnsen, K la Cour

Abstract

Background: During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.

Methods: The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone.

Discussion: The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others.

Trial registration: ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015.

Figures

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Randomisation and data collection

References

    1. Coleman MP, Quaresma M, Berrino F, Lutz JM, De Angelis R, Capocaccia R, et al. Cancer survival in five continents: a worldwide population-based study (CONCORD) Lancet Oncol. 2008;9:730–56. doi: 10.1016/S1470-2045(08)70179-7.
    1. Johnsen AT, Petersen MA, Pedersen L, Houmann LJ, Groenvold M. Do advanced cancer patients in Denmark receive the help they need? A nationally representative survey of the need related to 12 frequent symptoms/problems. Psychooncology. 2013;22:1724–30. doi: 10.1002/pon.3204.
    1. Sundhedsstyrelsen . Forløbsprogram for rehabilitering og palliation i forbindelse med kræft: del af samlet forløbsprogram for kræft. København: Sundhedsstyrelsen; 2012.
    1. World Health Organization . Cancer control: knowledge into action: WHO guide for effective programmes. Geneva: World Health Organization; 2007.
    1. Johnsen AT, Tholstrup D, Petersen MA, Pedersen L, Groenvold M. Health related quality of life in a nationally representative sample of haematological patients. Eur J Haematol. 2009;83:139–48. doi: 10.1111/j.1600-0609.2009.01250.x.
    1. Johnsen AT, Petersen MA, Pedersen L, Groenvold M. Symptoms and problems in a nationally representative sample of advanced cancer patients. Palliat Med. 2009;23:491–501. doi: 10.1177/0269216309105400.
    1. la Cour K, Johannessen H, Josephsson S. Activity and meaning making in the everyday lives of people with advanced cancer. Palliat. Support. Care. 2009;7:469–79. doi: 10.1017/S1478951509990472.
    1. Sviden GA, Tham K, Borell L. Involvement in everyday life for people with a life threatening illness. Palliat. Support. Care. 2010;8:345–52. doi: 10.1017/S1478951510000143.
    1. Cheville AL, Dose AM, Basford JR, Rhudy LM. Insights into the reluctance of patients with late-stage cancer to adopt exercise as a means to reduce their symptoms and improve their function. J Pain Symptom Manage. 2012;44:84–94. doi: 10.1016/j.jpainsymman.2011.08.009.
    1. Cheville AL, Troxel AB, Basford JR, Kornblith AB. Prevalence and treatment patterns of physical impairments in patients with metastatic breast cancer. J Clin Oncol. 2008;26:2621–9. doi: 10.1200/JCO.2007.12.3075.
    1. Rainbird K, Perkins J, Sanson-Fisher R, Rolfe I, Anseline P. The needs of patients with advanced, incurable cancer. Br J Cancer. 2009;101:759–64. doi: 10.1038/sj.bjc.6605235.
    1. Esbensen BA, Osterlind K, Hallberg IR. Quality of life of elderly persons with cancer: a 6-month follow-up. Scand J Caring Sci. 2007;21:178–90. doi: 10.1111/j.1471-6712.2007.00454.x.
    1. Vendrusculo FL. Qualify of life and daily activities performance after breast cancer treatment. Acta Paul Enfermagem. 2013;26:93–100. doi: 10.1590/S0103-21002013000100015.
    1. Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;383:1721–30. doi: 10.1016/S0140-6736(13)62416-2.
    1. Bakitas M, Lyons KD, Hegel MT, Balan S, Barnett KN, Brokaw FC, et al. The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Palliat Support Care. 2009;7:75–86. doi: 10.1017/S1478951509000108.
    1. Jones L, Fitzgerald G, Leurent B, Round J, Eades J, Davis S, et al. Rehabilitation in advanced, progressive, recurrent cancer: a randomized controlled trial. J Pain Symptom Manage. 2013;46:315–25. doi: 10.1016/j.jpainsymman.2012.08.017.
    1. Wærens E, Cour I, Brandt A. Activity problems important to people with advanced cancer living at home. 16th International Congress of the World Federation of Occupational Therapists. Japan: Yokohama; 2014.
    1. Brandt A, la Cour K, Wæhrens EE. The quality of ADL task performance based on self-report and observation in people living at home with cancer. 16th International Congress of the World Federation of Occupational Therapists. Japan: Yokohama; 2014.
    1. Peoples H, Brandt A, Wæhrens E, la Cour K. Occupational engagement and quality of life for people living with advanced cancer at home. 16th International Congress of the World Federation of Occupational Therapists. Japan: Yokohama; 2014.
    1. Lindahl-Jacobsen L, Hansen DG, la Cour K, Sondergaard J. Evaluation of a complex intervention to improve activities of daily living of disabled cancer patients: protocol for a randomised controlled study and feasibility of recruitment and intervention. BMC Health Serv Res. 2014;14:194. doi: 10.1186/1472-6963-14-194.
    1. Lindahl-Jacobsen L. Occupational therapy for cancer patients - a randomised, controlled study. Odense, Denmark: University of Southern Denmark; 2014.
    1. Rabow M, Kvale E, Barbour L, Cassel JB, Cohen S, Jackson V, et al. Moving upstream: a review of the evidence of the impact of outpatient palliative care. J Palliat Med. 2013;16:1540–9. doi: 10.1089/jpm.2013.0153.
    1. la Cour KNKJS. Everyday lives of people with advanced cancer: activity, time, location, and experience. OTJR. 2009;29:154–62.
    1. Hegel MT, Lyons KD, Hull JG, Kaufman P, Urquhart L, Li Z, et al. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy. Psychooncology. 2011;20:1092–101. doi: 10.1002/pon.1830.
    1. Mortenson WB, Demers L, Fuhrer MJ, Jutai JW, Lenker J, DeRuyter F. Effects of an assistive technology intervention on older adults with disabilities and their informal caregivers: an exploratory randomized controlled trial. Am J Phys Med Rehabil. 2013;92(4):297–306. doi: 10.1097/PHM.0b013e31827d65bf.
    1. Chase CA, Mann K, Wasek S, Arbesman M. Systematic review of the effect of home modification and fall prevention programs on falls and the performance of community-dwelling older adults. Am J Occup Ther. 2012;66:284–91. doi: 10.5014/ajot.2012.005017.
    1. Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. A randomized trial of a multicomponent home intervention to reduce functional difficulties in older adults. J Am Geriatr Soc. 2006;54:809–16. doi: 10.1111/j.1532-5415.2006.00703.x.
    1. Steultjens EM, Dekker J, Bouter LM, Jellema S, Bakker EB, van den Ende CH. Occupational therapy for community dwelling elderly people: a systematic review. Age Ageing. 2004;33:453–60. doi: 10.1093/ageing/afh174.
    1. Bjorkdahl A, Nilsson AL, Grimby G, Sunnerhagen KS. Does a short period of rehabilitation in the home setting facilitate functioning after stroke? A randomized controlled trial. Clin Rehabil. 2006;20:1038–49. doi: 10.1177/0269215506071230.
    1. Frank G. Life history model of adaptation to disability: the case of a ‘congenital amputee’. Soc Sci Med (1982) 1984;19:639–45. doi: 10.1016/0277-9536(84)90231-4.
    1. McCuaig M, Frank G. The able self: adaptive patterns and choices in independent living for a person with cerebral palsy. Am J Occup Ther. 1991;45:224–34. doi: 10.5014/ajot.45.3.224.
    1. World HO. WHO handbook for reporting results of cancer treatment. Geneva: World Health organization; 1979.
    1. Fisher AG, Jones KB. Assessment of motor and process skills, volume 1: developement, standardization, and administration manual. Fort Collins, Colorado: Three Star Press, Inc; 2010.
    1. Gerber LH, Hoffman K, Chaudhry U, Augustine E, Parks R, Bernad M, et al. Functional outcomes and life satisfaction in long-term survivors of pediatric sarcomas. Arch Phys Med Rehabil. 2006;87:1611–7. doi: 10.1016/j.apmr.2006.08.341.
    1. Parks R, Rasch EK, Mansky PJ, Oakley F. Differences in activities of daily living performance between long-term pediatric sarcoma survivors and a matched comparison group on standardized testing. Pediatr Blood Cancer. 2009;53:622–8. doi: 10.1002/pbc.22101.
    1. Clearinghouse E. Dansk IPPA. Et redskab til at afdække aktivitetsproblemer i hverdagen og evaluere indsatser - Manual. Odense, Denmark: Socialstyrelsen; 2014.
    1. Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, et al. IPPA, a user-centred approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105–15.
    1. Wessels R, Persson J, Lorentsen Ø, Andrich R, Ferrario M, Oortwijn W, et al. IPPA: Individually prioritised problem assessment. TechnolDisabil. 2002;14:141–5.
    1. Ghaziani E, Krogh AG, Lund H. Developing a Danish version of the “Impact on Participation and Autonomy Questionnaire”. Scand J Occup Ther. 2013;20:190–200. doi: 10.3109/11038128.2012.737370.
    1. Ghaziani E. Manual til den danske version af Impact on Participation and Autonomy questionnaire (IPA-DK). 2013. . Accessed 03 Nov 2015.
    1. Fayers P. The EORTC QLQ-C30 Scoring Manual (3rd Edition). 2001. . Accessed 03 Nov 2015.
    1. Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol. 1997;50:441–50. doi: 10.1016/S0895-4356(96)00428-3.
    1. Kaasa S, Bjordal K, Aaronson N, Moum T, Wist E, Hagen S, et al. The EORTC core quality of life questionnaire (QLQ-C30): validity and reliability when analysed with patients treated with palliative radiotherapy. Eur J Cancer. 1995;31A:2260–3. doi: 10.1016/0959-8049(95)00296-0.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20:1727–36. doi: 10.1007/s11136-011-9903-x.
    1. Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009;37:459–66. doi: 10.1177/1403494809105287.
    1. Dam K, Maribo T. Vurdering af EQ-5D, et måleredskab der viser helbredsrelateret livskvalitet. Danske Fysioterapeuter. 2005;1-16.
    1. Ellegård K, Nordell K. Att byta vanmakt mot egenmakt. Stockholm: Johansson & Skyttmo Forlag AB; 1997.
    1. Brinkmann S, Tanggaard L. Kvalitative metoder. En grundbog. København: Hans Reitzels Forlag; 2015.
    1. Davies CA. Reflexive ethnography: a guide to researching selves and others. 2nd ed. ASA research methods. London. New York: Routledge; 2008.
    1. Andersen JS, Olivarius Nde F, Krasnik A. The Danish National Health Service Register. Scand J Public Health. 2011;39:34–7. doi: 10.1177/1403494810394718.
    1. Goossens ME, Rutten-van Molken MP, Vlaeyen JW, van der Linden SM. The cost diary: a method to measure direct and indirect costs in cost-effectiveness research. J Clin Epidemiol. 2000;53:688–95. doi: 10.1016/S0895-4356(99)00177-8.
    1. Hjollund NH, Larsen FB, Andersen JH. Register-based follow-up of social benefits and other transfer payments: accuracy and degree of completeness in a Danish interdepartmental administrative database compared with a population-based survey. Scand J Public Health. 2007;35:497–502. doi: 10.1080/14034940701271882.
    1. Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the economic evaluation of health care programmes. Oxford: Oxford Univerity Press; 2005.
    1. Drummond R, Avril E, Jane H-P, Harrison-Paul J, Drummond AER. A randomised controlled trial of occupational therapy in oncology: challenges in conducting a pilot study. Br J Occup Ther. 2006;69:130–3. doi: 10.1177/030802260606900306.
    1. Kirkwood BR, Sterne JAC. Essential medical statistics. New York: John Wiley and Sons Ltd; 2013.
    1. Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012;31(4):328–40. doi: 10.1002/sim.4431.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and Elaboration. Ann Intern Med. 2008;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi: 10.1136/bmj.b2393.
    1. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553. doi: 10.1136/bmj.e1553.
    1. Rothwell PM. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005;365:176–86. doi: 10.1016/S0140-6736(05)17709-5.
    1. Corbin J, Strauss A. Basics of qualitative research: techniques and procedures for developing grounded theory. Thousand Oaks, California: Sage Publications; 2014.
    1. Efron B, Tibshirani RJ. An introduction to the bootstrap. Boca Raton, Florida: CRC press; 1994.
    1. Fenwick E, O’Brien BJ, Briggs A. Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. Health Econ. 2004;13:405–15. doi: 10.1002/hec.903.
    1. Williams JR. The declaration of Helsinki and public health. Bull World Health Organ. 2008;86:650–2. doi: 10.2471/BLT.08.050955.
    1. Barnett M. Interviewing terminally ill people: is it fair to take their time? Palliat Med. 2001;15:157–8. doi: 10.1191/026921601666846232.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: new guidance. United Kingdom: Medical Research Council; 2008.

Source: PubMed

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