A pilot randomised controlled trial of a multimodal supportive care (ThriverCare) intervention for managing unmet supportive care needs in men with metastatic prostate cancer on hormonal treatment and their partner/caregivers

European Journal of Oncology Nursing

Volumn 37, Issue , 2018, Pages 65-73

  Paterson, Catherine ^a   Primeau, Charlotte ^a   Nabi, Ghulam ^b  

^a ROBERT GORDON UNIVERSITY   (United Kingdom)

^b UNIVERSITY OF DUNDEE   (United Kingdom)

Author keywords

Intervention; Metastatic prostate cancer; Partner caregivers; Patient reported outcomes; Randomised controlled trial; Supportive care; Unmet needs

Indexed keywords

AGED; CAREGIVER; CONTROLLED STUDY; FEMALE; HUMAN; MALE; METHODOLOGY; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PALLIATIVE THERAPY; PATHOLOGY; PILOT STUDY; PROSPECTIVE STUDY; PROSTATE TUMOR; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCOTLAND;

AGED; CAREGIVERS; COMBINED MODALITY THERAPY; FEMALE; HUMANS; MALE; MIDDLE AGED; PALLIATIVE CARE; PILOT PROJECTS; PROSPECTIVE STUDIES; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RESEARCH DESIGN; SCOTLAND; SURVEYS AND QUESTIONNAIRES;

EID: 85056488151     PISSN: 14623889     EISSN: 15322122     Source Type: Journal    
DOI: 10.1016/j.ejon.2018.10.007     Document Type: Article

References (37)

1. Abernethy, A.P., Zafar, S.Y., Uronis, H., Wheeler, J.L., Coan, A., Rowe, K., Shelby, R.A., Fowler, R., Herndon, J.E. 2nd, Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients. J. Pain Symptom Manag. 40 (2010), 545–558.
2. Billingham, S., Whitehead, A., Julious, S., An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med. Res. Methodol., 13, 2013, 104.
3. Bonevski, B., Sanson-Fisher, R., Girgis, A., Burton, L., Cook, P., Boyes, A., Evaluation of an instrument to assess the needs of patients with cancer. Supportive care review group. Cancer 88 (2000), 217–225.
4. Bourke, L., Sohanpal, R., Nanton, V., Crank, H., Rosario, D.J., Saxton, J.M., A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy. Trials, 13, 2012, 208.
5. Carmack Taylor, C.L., Smith, M.A., de Moor, C., Dunn, A.L., Pettaway, C., Sellin, R., Charnsangavej, C., Hansen, M.C., Gritz, E.R., Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial. Contr. Clin. Trials 25 (2004), 265–285.
6. Carter, N., Bryant-Lukosius, D., DiCenso, A., Blythe, J., Neville, A.J., The supportive care needs of men with advanced prostate cancer. Oncol. Nurs. Forum 38 (2011), 189–198.
7. Chambers, S.K., Hyde, M.K., Laurie, K., Legg, M., Frydenberg, M., Davis, I.D., Lowe, A., Dunn, J., Experiences of Australian men diagnosed with advanced prostate cancer: a qualitative study. BMJ Open, 8, 2018, e019917.
8. Cockle-Hearne, J., Charnay-Sonnek, F., Denis, L., Fairbanks, H.E., Kelly, D., Kav, S., Leonard, K., van Muilekom, E., Fernandez-Ortega, P., Jensen, B.T., Faithfull, S., The impact of supportive nursing care on the needs of men with prostate cancer: a study across seven European countries. Br. J. Canc. 109 (2013), 2121–2130.
9. Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., Petticrew, M., Developing and evaluating complex interventions: the new Medical Research Council guidance. Br Med J, 337, 2008.
10. Doyle, N., Henry, R., Holistic needs assessment: rationale and practical implementation. Cancer Nurs. Pract. 13 (2014), 16–21.
11. Fitzpatrick, J.M., Bellmunt, J., Fizazi, K., Heidenreich, A., Sternberg, C.N., Tombal, B., Alcaraz, A., Bahl, A., Bracarda, S., Di Lorenzo, G., Efstathiou, E., Finn, S.P., FossÃ¥ S., Gillessen, S., Kellokumpu-Lehtinen, P.-L., Lecouvet, F.d.r.E., Oudard, S., de Reijke, T.M., Robson, C.N., De Santis, M., Seruga, B., de Wit, R., Optimal management of metastatic castration-resistant prostate cancer: highlights from a European expert consensus panel. Eur. J. Canc. 50 (2014), 1617–1627.
12. Greenhalgh, J., The applications of PROs in clinical practice: what are they, do they work, and why?. Qual. Life Res. 18 (2009), 115–123.
13. Hofman, A., Enhancing self-efficacy for optimised patient reported outcomes through the theory of symptom self-management. Cancer Nurs. 36:1 (2013), E16–E26.
14. Holm, L.V., Hansen, D.G., Kragstrup, J., Johansen, C., Christensen, R., Vedsted, P., Sondergaard, J., Influence of comorbidity on cancer patients’ rehabilitation needs, participation in rehabilitation activities and unmet needs: a population-based cohort study. Support. Care Canc. 22 (2014), 2095–2105.
15. Hui, D., Definition of supportive care: does the semantic matter?. Curr. Opin. Oncol. 26 (2014), 372–379.
16. Jensen, R.E., Snyder, C.F., Abernethy, A.P., Basch, E., Potosky, A.L., Roberts, A.C., Loeffler, D.R., Reeve, B.B., Review of electronic patient-reported outcomes systems used in cancer clinical care. J. Oncol. Pract. 10 (2014), e215–222.
17. Kang, M., Ragan, B.G., Park, J.-H., Issues in outcomes research: an overview of randomization techniques for clinical trials. J. Athl. Train. 43 (2008), 215–221.
18. King, A.J.L., Evans, M., Moore, T.H.M., Paterson, C., Sharp, D., Persad, R., Huntley, A.L., Prostate cancer and supportive care: a systematic review and qualitative synthesis of men's experiences and unmet needs. Eur. J. Canc. Care 24 (2015), 618–634.
19. McCabe, M.S., Bhatia, S., Oeffinger, K.C., Reaman, G.H., Tyne, C., Wollins, D.S., Hudson, M.M., American society of clinical oncology statement: achieving high-quality cancer survivorship care. J. Clin. Oncol. 31 (2013), 631–640.
20. Menichetti, J., Villa, S., Magnani, T., Avuzzi, B., Bosetti, D., Marenghi, C., Morlino, S., Rancati, T., Van Poppel, H., Salvioni, R., Valdagni, R., Bellardita, L., Lifestyle interventions to improve the quality of life of men with prostate cancer: a systematic review of randomized controlled trials. Crit. Rev. Oncol. Hematol. 108 (2016), 13–22.
21. Moore, T.H.M., King, A.J.L., Evans, M., Sharp, D., Persad, R., Huntley, A.L., Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials. Canc. Med. 4 (2015), 1240–1251.
22. Northouse, L.L., Mood, D.W., Schafenacker, A., Montie, J.E., Sandler, H.M., Forman, J.D., Hussain, M., Pienta, K.J., Smith, D.C., Kershaw, T., Randomized clinical trial of a family intervention for prostate cancer patients and their spouses. Cancer 110 (2007), 2809–2818.
23. Parahoo, K., McDonough, S., McCaughan, E., Noyes, J., Semple, C., Halstead, E.J., Neuberger, M.M., Dahm, P., Psychosocial interventions for men with prostate cancer: a Cochrane systematic review. BJU Int. 116 (2015), 174–183.
24. Paterson, C., Alashkham, A., Windsor, P., Nabi, G., Management and treatment of men affected by metastatic prostate cancer: evidence-based recommendations for practice. Int. J. Urol. Nurs. 10:1 (2016), 44–55.
25. Paterson, C., Kata, G., Nandwani, G., Daschaudhury, D., Nabi, G., Unmet supportive care needs of men with locally advanced and metastatic prostate cancer on hormonal treatment: a mixed methods study. Cancer Nurs. 40 (2017), 497–507.
26. Paterson, C., Nabi, G., A Model of consultation in prostate cancer care: evidence from a systematic review. Cancer Nurs. 40 (2017), 276–288.
27. Paterson, C., Robertson, A., Smith, A., Nabi, G., Identifying the unmet supportive care needs of men living with and beyond prostate cancer: a systematic review. Eur. J. Oncol. Nurs. 19 (2015), 405–418.
28. Primeau, C., Paterson, C., Nabi, G., A qualitative study exploring models of supportive care in men and their partners/caregivers affected by metastatic prostate cancer. Oncol. Nurs. Forum(44), 2017, E241–E249.
29. Schulz, K.F., Altman, D.G., Moher, D., CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Br Med J, 340, 2010 https://doi.org/10.1136/bmj.c332.
30. Snowden, A., Young, J., White, C., Murray, E., Richard, C., Lussier, M.-T., MacArthur, E., Storey, D., Schipani, S., Wheatley, D., Evaluating holistic needs assessment in outpatient cancer care—a randomised controlled trial: the study protocol. BMJ Open, 5, 2015, e006840.
31. Stanciu, M.A., Morris, C., Makin, M., Watson, E., Bulger, J., Evans, R., Hiscock, J., Hoare, Z., Edwards, R.T., Neal, R.D., A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol. BMJ Open, 5, 2015, e008470.
32. Sternberg, C.N., Baskin-Bey, E.S., Watson, M., Worsfold, A., Rider, A., Tombal, B., Treatment patterns and characteristics of European patients with castration-resistant prostate cancer. BMC Urol., 13, 2013 58-58.
33. Tabachnick, B., Fidell, L., Using Multivariate Statistics. 2007, Pearson Education, Boston.
34. Watson, E., Shinkins, B., Frith, E., Neal, D., Hamdy, F., Walter, F., Weller, D., Wilkinson, C., Faithfull, S., Wolstenholme, J., Sooriakumaran, P., Kastner, C., Campbell, C., Neal, R., Butcher, H., Matthews, M., Perera, R., Rose, P., Symptoms, unmet needs, psychological well-being and health status in survivors of prostate cancer: implications for redesigning follow-up. BJU Int. 117 (2016), E10–E19.
35. Weiner, D., Burhansstipanov, L., Krebs, L.U., Restivo, T., From survivorship to thrivership: native peoples weaving a healthy life from cancer. J. Canc. Educ. 20 (2005), 28–32.
36. Whitehead, A.L., Julious, S.A., Cooper, C.L., Campbell, M.J., Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat. Methods Med. Res. 25 (2016), 1057–1073.
37. Wight, D., Wimbush, E., Jepson, R., Doi, L., Six steps in quality intervention development (6SQuID). J. Epidemiol. Community 70:5 (2016), 520–525.