Trials | |
Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial | |
Penelope Schofield3  Dorothy King2  Lahiru Russell2  Jo Phipps-Nelson2  Jane Young5  Mei Krishnasamy3  Phyllis Butow1  Kerryann Lotfi-Jam3  Karla Gough2  Sanchia Aranda6  Michael Jefford4  | |
[1] Centre for Medical Psychology and Evidence-based Decision Making (CeMPED), School of Psychology, University of Sydney, A18, Sydney, NSW 2006, Australia;Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, VIC 3002, Australia;Department of Nursing, School of Health Sciences, The University of Melbourne, Parkville, VIC 3010, Australia;Faculty of Medicine, Dentistry and Health Services, University of Melbourne, Parkville, VIC 3010, Australia;Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Missenden Road, PO Box M157, Sydney, NSW 2050, Australia;Cancer Institute NSW, PO Box 41, Alexandria, NSW 1435, Australia | |
关键词: Nurse-led services; Models of care; Survivorship; Colorectal cancer; | |
Others : 1093219 DOI : 10.1186/1745-6215-14-260 |
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received in 2013-06-25, accepted in 2013-08-01, 发布年份 2013 | |
【 摘 要 】
Background
Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful.
Methods/design
This study is a multisite, randomised controlled trial, designed to assess the impact of the addition of the SurvivorCare intervention to usual post-treatment care, for people with potentially cured CRC. SurvivorCare comprises the provision of survivorship educational materials, a tailored survivorship care plan, an individually tailored nurse-led, face-to-face end of treatment consultation and three subsequent telephone calls. Eligible patients have completed treatment for potentially cured CRC. Other eligibility criteria include stage I to III disease, age greater than 18 years and adequate understanding of English. All consenting patients complete questionnaires at three time points over a six-month period (baseline, two and six months). Measures assess psychological distress, unmet needs and quality of life.
Discussion
This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings.
Trial registration
Australian New Zealand Clinical Trial Registry ACTRN12610000207011.
【 授权许可】
2013 Jefford et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150130161422989.pdf | 327KB | download | |
Figure 1. | 103KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]McDermid I, AIHW, AACR, NCSG: Cancer Incidence Projections Australia 2002 to 2011. Canberra, ACT: Australian Institute of Health and Welfare (AIHW), Australasian Association of Cancer Registries (AACR) and the National Cancer Strategies Group (NCSG); 2005.
- [2]Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D: Global cancer statistics. CA Cancer J Clin 2011, 61:69-90.
- [3]Edna T-H, Bjerkeset T: Small bowel obstruction in patients previously operated on for colorectal cancer. Eur J Surg 1998, 164:587-592.
- [4]Cahalane M, Shapiro M, Silen W: Abdominal incision: decision or indecision? Lancet 1989, 333:146-148.
- [5]Camilleri-Brennan J, Steele RJ: Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer. Br J Surg 2001, 88:1617-1622.
- [6]Moriya Y: Function preservation in rectal cancer surgery. Int J Clin Oncol 2006, 11:339-343.
- [7]Nugent K, Daniels P, Stewart B, Patankar R, Johnson C: Quality of life in stoma patients. Dis Colon Rectum 1999, 42:1569-1574.
- [8]Sprangers MAG, Taal BG, Aaronson NK, Velde A: Quality of life in colorectal cancer. Dis Colon Rectum 1995, 38:361-369.
- [9]Goldberg RM, Fleming TR, Tangen CM, Moertel CG, Macdonald JS, Haller DG, Laurie JA: Surgery for recurrent colon cancer: strategies for identifying resectable recurrence and success rates after resection. Ann Intern Med 1998, 129:27-35.
- [10]Arndt V, Merx H, Stegmaier C, Ziegler H, Brenner H: Restrictions in quality of life in colorectal cancer patients over three years after diagnosis: a population based study. Eur J Cancer 2006, 42:1848-1857.
- [11]Institute of Medicine, National Research Council: From Cancer Patient to Cancer Survivor: Lost in Transition. An American Society of Clinical Oncology and Institute of Medicine Symposium. Edited by Hewitt M, Greenfield S, Stovall E. Washington, DC: National Academies Press; 2006.
- [12]Ramsey SD, Berry K, Moinpour C, Giedzinska A, Andersen MR: Quality of life in long term survivors of colorectal cancer. Am J Gastroenterol 2002, 97:1228-1234.
- [13]Schag CA, Ganz PA, Wing DS, Sim MS, Lee JJ: Quality of life in adult survivors of lung, colon and prostate cancer. Qual Life Res 1994, 3:127-141.
- [14]Short PF, Vasey JJ, Tunceli K: Employment pathways in a large cohort of adult cancer survivors. Cancer 2005, 103:1292-1301.
- [15]Aziz N, Rowland J: Cancer survivorship research among ethnic minority and medically underserved groups. Oncol Nurs Forum 2002, 29:789-801.
- [16]Baravelli C, Krishnasamy M, Pezaro C, Schofield P, Lotfi-Jam K, Rogers M, Milne D, Aranda S, King D, Shaw B, Grogan S, Jefford M: The views of bowel cancer survivors and health care professionals regarding survivorship care plans and post treatment follow up. J Cancer Surviv 2009, 3:99-108.
- [17]Jefford M, Karahalios E, Pollard A, Baravelli C, Carey M, Franklin J, Aranda S, Schofield P: Survivorship issues following treatment completion-results from focus groups with Australian cancer survivors and health professionals. Journal of Cancer Survivorship 2008, 2:20-32.
- [18]Jefford M, Lotfi-Jam K, Baravelli C, Grogan S, Rogers M, Krishnasamy M, Pezaro C, Milne D, Aranda S, King D, Shaw B, Schofield P: Development and pilot testing of a nurse-led posttreatment support package for bowel cancer survivors. Cancer Nurs 2011, 34:E1-E10.
- [19]Karahalios A, Baravelli C, Carey M, Schofield P, Pollard A, Aranda S, Franklin J, Jefford M: An audiovisual information resource to assist in the transition from completion of potentially curative treatment for cancer through to survivorship: A systematic development process. Journal of Cancer Survivorship 2007, 1:226-236.
- [20]Jefford M, Karahalios A, Angle A, Baravelli C, Akkerman D: Understanding issues for cancer survivors: informing the development and evaluation of a written information booklet for survivors at treatment completion. Psychooncology 2007, 16:S273.
- [21]Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J: Self-management approaches for people with chronic conditions: a review. Patient Educ Couns 2002, 48:177-187.
- [22]Deadman JM, Leinster SJ, Owens RG, Dewey ME, Slade PD: Taking responsibility for cancer treatment. Soc Sci Med 2001, 53:669-677.
- [23]Addington-Hall JM, MacDonald LD, Anderson HR, Chamberlain J, Freeling P, Bland JM, Raftery J: Randomised controlled trial of effects of coordinating care for terminally ill cancer patients. BMJ 1992, 305:1317-1322.
- [24]Zabora J, Brintzenhofeszoc K, Jacobsen P, Curbow B, Piantadosi S, Hooker C, Owens A, Derogatis L: A new psychosocial screening instrument for use with cancer patients. Psychosomatics 2001, 42:241-246.
- [25]Love A; National Breast Cancer Centre: The Identification of Psychological Distress in Women with Breast Cancer. Camperdown, NSW, Australia: National Breast Cancer Centre; 2004.
- [26]Jacobsen PB, Donovan KA, Trask PC, Fleishman SB, Zabora J, Baker F, Holland JC: Screening for psychologic distress in ambulatory cancer patients. Cancer 2005, 103:1494-1502.
- [27]Gessler S, Low J, Daniells E, Williams R, Brough V, Tookman A, Jones L: Screening for distress in cancer patients: is the distress thermometer a valid measure in the UK and does it measure change over time? A prospective validation study. Psychooncology 2008, 17:538-547.
- [28]Hodgkinson K, Butow P, Hunt GE, Pendlebury S, Hobbs KM, Lo SK, Wain G: The development and evaluation of a measure to assess cancer survivors’ unmet supportive care needs: the CaSUN (cancer survivors’ unmet needs measure). Psychooncology 2007, 16:796-804.
- [29]Pearce NJ, Sanson-Fisher R, Campbell HS: Measuring quality of life in cancer survivors: a methodological review of existing scales. Psychooncology 2008, 17:629-640.
- [30]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F: 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.
- [31]Sprangers MA, te Velde A, Aaronson NK: The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). Eur J Cancer 1999, 35:238-247.
- [32]King MT: A point of minimal important difference (MID): a critique of terminology and methods. Expert review of pharmacoeconomics & outcomes research 2011, 11:171-184.
- [33]Hochberg Y: A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988, 75:800-802.
- [34]Himelhoch S, Weller WE, Wu AW, Anderson GF, Cooper LA: Chronic medical illness, depression, and use of acute medical services among medicare beneficiaries. Med Care 2004, 42:512-521.