A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): Study protocol for a randomised controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Schofield, Penelope ^a,b   Juraskova, Ilona ^c   Bergin, Rebecca ^a   Gough, Karla ^a   Mileshkin, Linda ^a,b   Krishnasamy, Meinir ^a,b   White, Kate ^c,d   Bernshaw, David ^a   Penberthy, Sylvia ^a   Aranda, Sanchia ^a,b,e  

^a PETER MACCALLUM CANCER CENTRE   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^e CANCER INSTITUTE NSW   (Australia)

Author keywords

Distress; Gynaecological cancer; Intervention; Nurse; Peer support; Psychosexual function; Quality of life; Radiotherapy; RCT

Indexed keywords

ARTICLE; CANCER RADIOTHERAPY; CAREGIVER SUPPORT; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; CLINICAL SUPERVISION; DISTRESS SYNDROME; GYNECOLOGIC CANCER; HUMAN; ILLNESS TRAJECTORY; PEER GROUP; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEXUALITY; TELECONSULTATION; VAGINA DISEASE; WORKSHOP;

CLINICAL PROTOCOLS; FEMALE; GENITAL NEOPLASMS, FEMALE; HUMANS; NURSES; PEER GROUP; PROSPECTIVE STUDIES; QUALITY OF LIFE; REFERRAL AND CONSULTATION; SELF CARE; SEXUAL BEHAVIOR; TELEPHONE;

EID: 84873502102     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-39     Document Type: Article

References (74)

1. Sankaranarayanan R, Ferlay J. Worldwide burden of gynaecological cancer: The size of the problem. Best Pract Res Clin Obstet Gynaecol 2006, 20:207-225. 10.1016/j.bpobgyn.2005.10.007, 16359925.
2. Frumovitz M, Sun CC, Schover LR, Munsell MF, Jhingran A, Wharton JT, Eifel P, Bevers TB, Levenback CF, Gershenson DM, Bodurka DC. Quality of life and sexual functioning in cervical cancer survivors. J Clin Oncol 2005, 23:7428-7436. 10.1200/JCO.2004.00.3996, 16234510.
3. Munro AJ, Potter S. A quantitative approach to the distress caused by symptoms in patients treated with radical radiotherapy. Br J Cancer 1996, 74:640-647. 10.1038/bjc.1996.414, 2074677, 8761383.
4. Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: randomized PORTEC-2 trial. J Clin Oncol 2009, 27:3547-3556. 10.1200/JCO.2008.20.2424, 19546404.
5. Olopade FA, Norman A, Blake P, Dearnaley DP, Harrington KJ, Khoo V, Tait D, Hackett C, Andreyev HJN. A modified Inflammatory Bowel Disease questionnaire and the Vaizey Incontinence questionnaire are simple ways to identify patients with significant gastrointestinal symptoms after pelvic radiotherapy. Br J Cancer 2005, 92:1663-1670. 10.1038/sj.bjc.6602552, 2362022, 15856043.
6. Maduro JH, Pras E, Willemse PHB, de Vries EGE. Acute and long-term toxicity following radiotherapy alone or with chemotherapy for locally advanced cervical cancer. Cancer Treat Rev 2003, 29:471-488. 10.1016/S0305-7372(03)00117-8, 14585258.
7. Denton AS, Maher EJ. Interventions for the physical aspects of sexual dysfunction in women following pelvic radiotherapy. Cochrane Database Syst Rev 2003, (1):CD003750.
8. Juraskova I. Quality of LIFE / Quality of SEX: Psycho-sexual adjustment following gynaecological cancer 2009, Saarbrücken: VDM Verlag Dr. Müller.
9. Bourgeois-Law G, Lotocki R. Sexuality and gynaecological cancer: a needs assessment. Can J Hum Sex 1999, 8:231-240.
10. Schreier A, Williams S. Anxiety and quality of life of women who receive radiation or chemotherapy for breast cancer. Oncol Nurs Forum 2004, 31:127-130. 10.1188/04.ONF.127-130, 14722597.
11. Hipkins J, Whitworth M, Tarrier N, Jayson G. Social support, anxiety and depression after chemotherapy for ovarian cancer: a prospective study. Br J Health Psychol 2004, 9:569-581. 10.1348/1359107042304542, 15509362.
12. Suls J, Wan C. Effects of sensory and procedural information on coping with stressful medical procedures and pain: a meta-analysis. J Consult Clin Psychol 1989, 57:372-379.
13. Hathaway D. Effect of preoperative instruction on postoperative outcomes: a meta-analysis. Nurs Res 1986, 35:269-275.
14. Robinson JW, Faris PD, Scott CB. Psycho-educational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys 1999, 44:497-506. 10.1016/S0360-3016(99)00048-6, 10348277.
15. Lancaster L. Preventing vaginal stenosis after brachytherapy for gynaecological cancer: an overview of Australian practices. Eur J Oncol Nurs 2004, 8:30-39. 10.1016/S1462-3889(03)00059-0, 15003742.
16. Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev 2010, (9):CD007291.
17. Taskforce GMC. Best Clinical Practice: Gynecological Cancer Guidelines 2009 2009, Sydney: NSW Department of Health.
18. National Forum of Gynaecological Oncology Nurses Best Practice Guidelines on the use of vaginal dilators in women receiving pelvic radiotherapy 2005, Oxon: Owen Mumford, National Forum of Gynaecological Oncology Nurses.
19. Network SIG. Management of cervical cancer: A national clinical guideline 2008, Edinburgh: Scottish Intercollegiate Guidelines Network.
20. Wolfson AH, Varia MA, Moore D, Rao GG, Gaffney DK, Erickson-Wittmann BA, Jhingran A, Mayr NA, Puthawala AA, Small W, Yashar CM, Yuh W, Cardenes HR, American College of Radiology (ACR) ACR Appropriateness Criteria® role of adjuvant therapy in the management of early stage cervical cancer. Gynecol Oncol 2012, 125:256-262. 10.1016/j.ygyno.2011.11.048, 22155418, American College of Radiology (ACR).
21. Poroch D. The effect of preparatory patient education on the anxiety and satisfaction of cancer patients receiving radiation therapy. Cancer Nurs 1995, 18:206-214.
22. Bennenbroek FTC, Buunk BP, Stiegelis HE, Hagedoorn M, Sanderman R, Van den Bergh ACM, Botke G. Audiotaped social comparison information for cancer patients undergoing radiotherapy: Differential effects of procedural, emotional and coping information. Psychooncology 2003, 12:567-579. 10.1002/pon.674, 12923797.
23. Lotfi-Jam K, Carey M, Jefford M, Schofield P, Charleson C, Aranda S. Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review. J Clin Oncol 2008, 26:5618-5629. 10.1200/JCO.2007.15.9053, 18981466.
24. Lorig K, Feigenbaum P, Regan C, Ung E, Chastain RL, Holman HR. A comparison of lay-taught and professional-taught arthritis self-management courses. J Rheumatol 1986, 13:763-767.
25. 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. 10.1016/S0738-3991(02)00032-0, 12401421.
26. Cox K, Wilson E. Follow-up for people with cancer: nurse-led services and telephone interventions. J Adv Nurs 2003, 43:51-61. 10.1046/j.1365-2648.2003.02672.x, 12801396.
27. Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology 2003, 12:267-279. 10.1002/pon.639, 12673810.
28. Addington-Hall JM, MacDonald LD, Anderson HR, Chamberlain J, Freeling P, Bland JM, Raftery J. Randomised controlled trial of the effects of coordinating care for terminally ill cancer patients. Br Med J 1992, 305:1317-1322.
29. Aranda S, Jefford M, Yates P, Gough K, Seymour J, Francis P, Baravelli C, Breen S, Schofield P. Impact of a novel nurse-led prechemotherapy education intervention (ChemoEd) on patient distress, symptom burden, and treatment-related information and support needs: results from a randomised, controlled trial. Ann Oncol 2012, 23:222-231. 10.1093/annonc/mdr042, 21471562.
30. Ley P. Memory for medical information. Br J Soc Clin Psychol 1979, 18:245-255. 10.1111/j.2044-8260.1979.tb00333.x, 454984.
31. Gysels M, Richardson A, Higginson IJ. Communication training for health professionals who care for patients with cancer: a systematic review of effectiveness. Support Care Cancer 2004, 12:692-700. 10.1007/s00520-004-0666-6, 15258839.
32. Steginga S, Hutchinson SD, Turner J. Translating psychosocial care: Guidelines. Cancer Forum 2006, 30:28-31.
33. Hoey LM, Leropoli SC, White VM, Jefford M. Systematic review of peer-support programs for people with cancer. Patient Educ Couns 2008, 70:315-337. 10.1016/j.pec.2007.11.016, 18191527.
34. Campbell HS, Phaneuf MR, Deane K. Cancer peer support programs-do they work?. Patient Educ Couns 2004, 55:3-15. 10.1016/j.pec.2003.10.001, 15476984.
35. Dunn J, Steginga SK, Rosoman N, Millichap D. A review of peer support. J Psychosoc Oncol 2003, 21:55-67.
36. Macvean ML, White VM, Pratt S, Grogan S, Sanson-Fisher R. Reducing the unmet needs of patients with colorectal cancer: a feasibility study of The Pathfinder Volunteer Program. Support Care Cancer 2007, 15:293-299. 10.1007/s00520-006-0128-4, 16947039.
37. Houts PS, Whitney CW, Mortel R, Bartholomew MJ. Former cancer patients as counselors of newly diagnosed cancer patients. J Natl Cancer Inst 1986, 76:793-796.
38. Rudy RR, Rosenfeld LB, Galassi JP, Parker J, Schanberg R. Participants' perceptions of a peer-helper, telephone-based social support intervention for melanoma patients. Health Commun 2001, 13:285-305. 10.1207/S15327027HC1303_4, 11550852.
39. Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton B, Cook P. The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer 2000, 88:226-237. 10.1002/(SICI)1097-0142(20000101)88:1<226::AID-CNCR30>3.0.CO;2-P, 10618627.
40. Jacobson P, Donovan K, Trask P, Fleishman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer 2005, 103:1494-1502. 10.1002/cncr.20940, 15726544.
41. Kaplan RM, Atkins CJ, Lenhard L. Coping with stressful sigmoidoscopy. Evaluation of cognitive and relaxation procedures. J Behav Med 1982, 5:67-82. 10.1007/BF00845257, 7120377.
42. Bonner C, Nattress K, Anderson C, Carter J, Milross C, Philp S, Juraskova I. Chore or priority? Barriers and facilitators affecting dilator use after pelvic radiotherapy for gynaecological cancer. Support Care Cancer 2012, 20:2305-2313. 10.1007/s00520-011-1337-z, 22160621.
43. 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. J Cancer Surviv 2008, 2:20-32. 10.1007/s11764-008-0043-4, 18648984.
44. Macvean ML, White VM, Sanson-Fisher R. One-to-one volunteer support programs for people with cancer: a review of the literature. Patient Educ Couns 2008, 70:10-24. 10.1016/j.pec.2007.08.005, 17904782.
45. Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002, 24:547-561. 10.1016/S0885-3924(02)00529-8, 12551804.
46. King MT, Stockler MR, Cella DF, Osoba D, Eton DT, Thompson J, Eisenstein AR. Meta-analysis provides evidence-based effect sizes for a cancer-specific quality-of-life questionnaire, the FACT-G. J Clin Epidemiol 2009, 63:270-281.
47. Hinz A, Zweynert U, Kittel J, Igl W, Schwarz R. Measurement of change with the Hospital Anxiety and Depression Scale (HADS): sensitivity and reliability of change. Psychother Psychosom Med Psychol 2009, 59:394-400. 10.1055/s-2008-1067578, 18988141.
48. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309. CONSORT Group.
49. Cherny NI, Abernethy AP, Strasser F, Sapir R, Currow D, Zafar SY. Improving the methodologic and ethical validity of best supportive care studies in oncology: a systematic review. J Clin Oncol 2009, 27:5476-5486. 10.1200/JCO.2009.21.9592, 19564538.
50. LENT SOMA tables. Radiother Oncol 1995, 35:17-60.
51. Late effects consensus conference Late effects consensus conference: RTOG/EORTC. Radiother Oncol 1995, 35:5-7. 10.1016/0167-8140(95)01548-U, 7569013, Late effects consensus conference.
52. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370. 10.1111/j.1600-0447.1983.tb09716.x, 6880820.
53. Pallant JF, Tennant A. An introduction to the Rasch measurement model: An example using the Hospital Anxiety and Depression Scale (HADS). Br J Clin Psychol 2007, 46:1-18. 10.1348/014466506X96931, 17472198.
54. Rodgers J, Martin CR, Morse RC, Kendell K, Verrill M. An investigation into the psychometric properties of the Hospital Anxiety and Depression Scale in patients with breast cancer. Health Qual Life Outcomes 2005, 3:41. 10.1186/1477-7525-3-41, 1184094, 16018801.
55. Spinhoven P, Ormel J, Sloekers P. A validation study of the Hospital Anxiety and Depression scale (HADS) in different groups of Dutch subjects. Psychol Med 1997, 27:363-370. 10.1017/S0033291796004382, 9089829.
56. Kornblith AB, Dowell JM, Herndon JE, Engelman BJ, Bauer-Wu S, Small EJ, Morrison VA, Atkins J, Cohen HJ, Holland JC. Telephone monitoring of distress in patients aged 65 years or older with advanced stage cancer: a cancer and leukemia group B study. Cancer 2006, 107:2706-2714. 10.1002/cncr.22296, 17078057.
57. Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia. J Clin Oncol 2008, 26:4651-4658. 10.1200/JCO.2007.13.9006, 18591549.
58. Smith AB, Wright P, Selby PJ, Velikova G. A Rasch and factor analysis of the Functional Assessment of Cancer Therapy-General (FACT-G). Health Qual Life Outcomes 2007, 5:19. 10.1186/1477-7525-5-19, 1863414, 17448239.
59. Winstead-Fry P, Schultz A. Psychometric analysis of the Functional Assessment of Cancer Therapy-General (FACT-G) scale in a rural sample. Cancer 1997, 79:2446-2452. 10.1002/(SICI)1097-0142(19970615)79:12<2446::AID-CNCR23>3.0.CO;2-Q, 9191537.
60. Powell CB, Kneier A, Chen LM, Rubin M, Kronewetter C, Levine E. A randomized study of a brief psychosocial intervention for women attending a gynecologic cancer clinic. Gynecol Oncol 2008, 111:137-143.
61. McElduff P, Boyes A, Zucca A. Supportive Care Needs Survey. A guide to administration, scoring and analysis 2004, Newcastle: ChERP.
62. Schofield P, Gough K, Lotfi-Jam K, Aranda S. Validation of the Supportive Care Needs Survey-short form 34 with a simplified response format in men with prostate cancer. Psychooncology 2011, 21:1107-1112.
63. Cossich T, Schofield PE, MacLachlan SA. Validation of the Cancer Needs Questionnaire (CNQ) short form version in an ambulatory cancer setting. Qual Life Res 2004, 13:1225-1233.
64. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomised controlled trial. Br J Cancer 2006, 95:667-673. 10.1038/sj.bjc.6603320, 2360523, 16967054.
65. Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The Memorial Symptom Assessment Scale Short Form (MSAS-SF). Cancer 2000, 89:1162-1171. 10.1002/1097-0142(20000901)89:5<1162::AID-CNCR26>3.0.CO;2-Y, 10964347.
66. Hwang SS, Chang VT, Fairclough DL, Cogswell J, Kasimis B. Longitudinal quality of life in advanced cancer patients: pilot study results from a VA medical cancer center. J Pain Symptom Manage 2003, 25:225-235. 10.1016/S0885-3924(02)00641-3, 12614957.
67. Jensen PT, Groenvold M, Klee MC, Thranov I, Petersen MA, Machin D. Longitudinal study of sexual function and vaginal changes after radiotherapy for cervical cancer. Int J Radiat Oncol Biol Phys 2003, 56:937. [Erratum appears in Int J Radiat Oncol Biol Phys 2004;58:1321], 10.1016/S0360-3016(03)00362-6, 12829128.
68. Jensen PT, Klee MC, Thranov I, Groenvold M. Validation of a questionnaire for self-assessment of sexual function and vaginal changes after gynaecological cancer. Psychooncology 2004, 13:577-592. 10.1002/pon.757, 15295778.
69. Schofield P, Gough K, Ugalde A, Carey M, Aranda S, Sanson-Fisher R. Cancer Treatment Survey (CaTS): development and validation of a new instrument to measure patients' preparation for chemotherapy and radiotherapy. Psychooncology 2012, 21:307-315. 10.1002/pon.1896, 22383272.
70. Hox J. Multilevel Analysis: Techniques and Applications 2002, Mahwah, NJ: Lawrence Erlbaum Associates.
71. Yancy WS, Almirall D, Maciejewski ML, Kolotkin RL, McDuffie JR, Westman EC. Effects of two weight-loss diets on health-related quality of life. Qual Life Res 2009, 18:281-289. 10.1007/s11136-009-9444-8, 19212822.
72. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10:407-415. 10.1016/0197-2456(89)90005-6, 2691207.
73. Jaeschke R, Guyatt GH, Keller J, Singer J. Interpreting changes in quality-of-life score in N of 1 randomized trials. Control Clin Trials 1991, Suppl 4:226S-233S.
74. Carlson LE, Bultz BD. Efficacy and medical cost offset of psychosocial interventions in cancer care: Making the case for economic analyses. Psychooncology 2004, 13:837-849. 10.1002/pon.832, 15578622.