A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol

BMC Cancer

Volumn 11, Issue , 2011, Pages

  Mann, Eleanor ^a   Smith, Melanie ^a   Hellier, Jennifer ^a   Hunter, Myra S ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; BEHAVIOR CHANGE; BREAST CANCER; CANCER PATIENT; COGNITIVE THERAPY; CONTROLLED STUDY; FEMALE; FOLLOW UP; GROUP THERAPY; HEALTH BELIEF; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; MENOPAUSAL SYNDROME; MOOD; MULTICENTER STUDY; NIGHT SWEAT; OPTIMISM; OUTCOME ASSESSMENT; PATIENT MONITORING; PSYCHOEDUCATION; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SKIN CONDUCTANCE; THERAPY EFFECT; TREATMENT DURATION; UNITED KINGDOM; AGED; BREAST TUMOR; CARCINOMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; MENOPAUSE; MENTAL STRESS; METHODOLOGY; MIDDLE AGED; PHYSIOLOGY; PSYCHOLOGICAL ASPECT; SWEATING; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; BREAST NEOPLASMS; CARCINOMA; COGNITIVE THERAPY; FEMALE; FOLLOW-UP STUDIES; HOT FLASHES; HUMANS; MENOPAUSE; MIDDLE AGED; STRESS, PSYCHOLOGICAL; SWEATING; TREATMENT OUTCOME;

EID: 79251552530     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-11-44     Document Type: Article

References (68)

1. Freeman E, Sherif K. Prevalence of hot flushes and night sweats around the world: a systematic review. Climacteric 2007, 10:197-214. 10.1080/13697130601181486, 17487647.
2. Carpenter J, Elam J, Ridner S, Carney P, Cherry G, Cucullu H. Sleep, fatigue, and depressive symptoms in breast cancer survivors and matched healthy women experiencing hot flashes. Oncology Nursing Forum 2004, 31:591-598. 10.1188/04.ONF.591-598, 15146224.
3. Hunter MS, Grunfeld EA, Mittal S, Sikka P, Ramirez AJ, Fentiman I, Hamed H. Menopausal symptoms in women with breast cancer: prevalence and treatment preferences. Psychooncology 2004, 13:769-778. 10.1002/pon.793, 15386641.
4. Gupta P, Sturdee DW, Hunter MS. Mid-age health in women from the Indian subcontinent (MAHWIS): general health and the experience of menopause in women. Climacteric 2006, 9:13-22. 10.1080/13697130500515776, 16428121.
5. Mom CH, Buijs C, Willemse PHB, Mourits MJE, de Vries EGE. Hot flushes in breast cancer patients. Crit Rev Oncol Hematol 2006, 57:63-77.
6. Pradhan A, Manson J, Rossouw J, Siscovick D, Mouton C, Rifai N, Wallace R, Jackson R, Pettinger M, Ridker P. Inflammatory biomarkers, hormone replacement therapy, and incident coronary heart disease: prospective analysis from the Women's Health Initiative observational study. Journal of the American Medical Association 2002, 288:980-987. 10.1001/jama.288.8.980, 12190368.
7. Beral V. Ovarian cancer and hormone replacement therapy in the Million Women Study. The Lancet 2007, 369:1703-1710.
8. Utian W. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes 2005, 3:47-57. 10.1186/1477-7525-3-47, 1190205, 16083502.
9. Dalal S, Zhukovsky D. Pathophysiology and management of hot flashes. Journal of Supportive Oncology 2006, 4:315-320.
10. Freedman R. Hot flashes: behavioral treatments, mechanisms, and relation to sleep. The American Journal of Medicine 2005, 118:124-130. 10.1016/j.amjmed.2005.09.046, 16414337.
11. Freedman R, Krell W. Reduced thermoregulatory null zone in postmenopausal women with hot flashes. Am J Obstet Gynecol 1999, 181:66-70. 10.1016/S0002-9378(99)70437-0, 10411797.
12. Swartzman LC, Edelberg R, Kemmann E. Impact of stress on objectively recorded menopausal hot flushes and on flush report bias. Health Psychol 1990, 9:529-545. 10.1037/0278-6133.9.5.529, 2226383.
13. Freeman E, Sammel M, Lin H, Gracia C, Kapoor S, Ferdousi T. The role of anxiety and hormonal changes in menopausal hot flashes. Menopause 2005, 12:258-266. 10.1097/01.GME.0000142440.49698.B7, 15879914.
14. Hunter MS, Rendall MJ. Bio-psycho-socio-cultural perspectives on menopause. Best Practice & Research: Clinical Obstetrics & Gynaecology 2007, 21:261-274.
15. Rendall MJ, Simonds LM, Hunter MS. The Hot Flush Beliefs Scale: A tool for assessing thoughts and beliefs associated with the experience of menopausal hot flushes and night sweats. Maturitas 2008, 60:158-169. 10.1016/j.maturitas.2008.05.001, 18554828.
16. Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res 2010, 69:491-501. 10.1016/j.jpsychores.2010.04.005, 20955869.
17. Miller H, Li R. Measuring hot flashes: summary of a National Institutes of Health workshop. Mayo Clin Proc 2004, 79:777-781. 10.4065/79.6.777, 15182093.
18. Mann E, Hunter MS. Concordance between self-reported and sternal skin conductance measures of hot flushes in symptomatic menopausal women: a systematic review. Menopause
19. Carpenter J, Storniolo A, Johns S, Monahan P, Azzouz F, Elam J, Johnson C, Shelton R. Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist 2007, 12:124-135. 10.1634/theoncologist.12-1-124, 17227907.
20. Stearns V, Ullmer L, Lopez J, Smith Y, Isaacs C, Hayes D. Hot flushes. The Lancet 2002, 360:1851-1861.
21. Hunter MS, Haqqani JR. An investigation of subjective perceptions and physiological measures of hot flushes and night sweats. Climacteric 2011, 13:146-151. 10.3109/13697131003735585, 20443722.
22. Dormire S, Carpenter J. An alternative to Unibase/glycol as an effective nonhydrating electrolyte medium for the measurement of electrodermal activity. Psychophysiology 2002, 39:423-426. 10.1111/1469-8986.3940423, 12212634.
23. Nelson H, Vesco K, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes systematic review and meta-analysis. Journal of the American Medical Association 2006, 295:2057-2071. 10.1001/jama.295.17.2057, 16670414.
24. Santoro N, Clarkson T, Freedman R, Fugh-Berman A, Loprinzi C, Reame N. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause 2004, 11:11-33. 10.1097/01.GME.0000143307.00654.A1, 14716179.
25. Andersohn F, Willich SN. Interaction of serotonin reuptake inhibitors with tamoxifen. BMJ 340.
26. Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric 2009, 12:16-25. 10.1080/13697130802566980, 19116803.
27. Dos Santos S, Hill N, Morgan A, Smith J, Thai C, Cheifetz O. Acupuncture for Treating Common Side Effects Associated With Breast Cancer Treatment: A Systematic Review. Medical Acupuncture 22:81-97.
28. Hervik J, Mjåland O. Acupuncture for the treatment of hot flashes in breast cancer patients, a randomized, controlled trial. Breast Cancer Res Treat 2009, 116:311-316. 10.1007/s10549-008-0210-3, 18839306.
29. Cho S, Whang W. Acupuncture for vasomotor menopausal symptoms: a systematic review. Menopause 2009, 16:1065-1073. 10.1097/gme.0b013e3181a48abd, 19424092.
30. Nir Y, Huang M, Schnyer R, Chen B, Manber R. Acupuncture for postmenopausal hot flashes. Maturitas 2007, 56:383-395. 10.1016/j.maturitas.2006.11.001, 17182200.
31. Daley A, Stokes-Lampard H, MacArthur C. Exercise to reduce vasomotor and other menopausal symptoms: A review. Maturitas 2009, 63:176-180. 10.1016/j.maturitas.2009.02.004, 19285813.
32. Elavsky S, McAuley E. Personality, menopausal symptoms, and physical activity outcomes in middle-aged women. Personality and Individual Differences 2009, 46:123-128. 10.1016/j.paid.2008.09.014, 2621079, 20046213.
33. Duijts S, Oldenburg H, van Beurden M, Aaronson N. Cognitive behavioral therapy and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: design of a multicenter trial. BMC Womens Health 2009, 9. 10.1186/1472-6874-9-15, 2706817, 19500403.
34. Raghavendra RM, Vadiraja HS, Nagarathna R, Nagendra HR, Rekha M, Vanitha N, Gopinath KS, Srinath BS, Vishweshwara MS, Madhavi YS, et al. Effects of a yoga program on cortisol rhythm and mood states in early breast cancer patients undergoing adjuvant radiotherapy: A randomized controlled trial. Integrative Cancer Therapies 2009, 8:37-46. 10.1177/1534735409331456, 19190034.
35. Lee MS, Kim JI, Ha JY, Boddy K, Ernst E. Yoga for menopausal symptoms: a systematic review. Menopause 2009, 16:602-608. 10.1097/gme.0b013e31818ffe39, 19169169.
36. Chattha R, Raghuram N, Venkatram P, Hongasandra N. Treating the climacteric symptoms in Indian women with an integrated approach to yoga therapy: a randomized control study. Menopause 2008, 15:862-870. 10.1097/gme.0b013e318167b902, 18463543.
37. Booth-LaForce C, Thurston R, Taylor M. A pilot study of a Hatha yoga treatment for menopausal symptoms. Maturitas 2007, 57:286-295. 10.1016/j.maturitas.2007.01.012, 17336473.
38. Freedman R, Woodward S. Behavioral treatment of menopausal hot flushes: evaluation by ambulatory monitoring. Am J Obstet Gynecol 1992, 167:436-439.
39. Irvin J, Domar A, Clark C, Zuttemzeister P, Friedman R. The effects of relaxation response training on menopausal symptoms. Journal of Psychosomatic Obstetrics & Gynecology 1996, 17:202-207.
40. Nedstrand E, Wijma K, Wyon Y, Hammar M. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Maturitas 2005, 51:154-162. 10.1016/j.maturitas.2004.05.017, 15917156.
41. Wijma K, Melin A, Nedstrand E, Hammar M. Treatment of menopausal symptoms with applied relaxation: A pilot study. J Behav Ther Exp Psychiatry 1997, 28:251-261. 10.1016/S0005-7916(97)00030-X, 9489686.
42. Nedstrand E, Wijma K, Wyon Y, Hammar M. Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study. Climacteric 2005, 8:243-250. 10.1080/13697130500118050, 16390756.
43. Fenlon D. Relaxation therapy as an intervention for hot flushes in women with breast cancer. European Journal of Oncology Nursing 1999, 3:223-231.
44. Ganz Greendale G, Peterson, Zibecchi, Kahn, Belin. Managing menopausal symptoms in breast cancer survivors: Results of a randomised controlled trial. J Natl Cancer Inst 2000, 92:1054-1064. 10.1093/jnci/92.13.1054, 10880548.
45. Hunter MS, Liao KLM. Evaluation of a four-session cognitive-behavioural intervention for menopausal hot flushes. British Journal of Health Psychology 1996, 1:113-125.
46. Hunter MS. Cognitive behavioural interventions for premenstrual and menopausal symptoms. Journal of Reproductive and Infant Psychology 2003, 21:183-193.
47. Hunter MS, Coventry S, Hamed H, Fentiman I, Grunfeld EA. Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psychooncology 2009, 18:560-563. 10.1002/pon.1414, 18646246.
48. Keefer L, Blanchard E. A Behavioral Group Treatment Program for Menopausal Hot Flashes: Results of a Pilot Study. Appl Psychophysiol Biofeedback 2005, 30:21-30. 10.1007/s10484-005-2171-1, 15889583.
49. Hunter MS. The Women's Health Questionnaire: a measure of mid-aged women's perceptions of their emotional and physical health. Psychology & Health 1992, 7:45-54.
50. Hunter MS, Coventry S, Mendes N, Grunfeld EA. Menopausal symptoms following breast cancer treatment: a qualitative investigation of cognitive and behavioural responses. Maturitas 2009, 63:336-340. 10.1016/j.maturitas.2009.06.003, 19616392.
51. World Medical Association Declaration of Helsinki. 2008, Retrieved 13 Jan 2009, World Medical Association., http://www.wma.net/en/30publications/10policies/b3/17c.pdf
52. Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol 2007, 27:379-387.
53. Ashford S, French D, Sniehotta F, Bishop A, Michie S. The refinement of a taxonomy of techniques to change behaviour. 2009, http://www.coventry.ac.uk/researchnet/d/276/a/6239
54. Harvey A cognitive theory and therapy for chronic Insomnia. Journal of Cognitive Psychotherapy: An International Quarterly 2005, 19:41-59. Harvey.
55. Hunter MS, Liao KLM. A psychological analysis of menopausal hot flushes. Br J Clin Psychol 1995, 34:589-599.
56. Webster J, Bahr D, Shults M, Grady D, Macer J. A miniature sternal skin-attached hot flash recorder. Springer Science and Business Media 2007, 14:676-680.
57. Carpenter J, Monahan P, Azzouz F. Accuracy of subjective hot flush reports compared with continuous sternal skin conductance monitoring. Obstet Gynecol 2004, 104:1322-1326. 10.1097/01.AOG.0000143891.79482.ee, 15572497.
58. Ware J, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide 1993, 2000. Lincoln, RI: QualityMetric Incorporated.
59. Ware J, Kosinski M. SF-36 physical & mental health summary scales: A manual for users of version 1 2001, Lincoln, RI: QualityMetric Incorporated, 2.
60. Hunter MS. The Women's Health Questionnaire (WHQ): frequently asked questions (FAQ). Health and Quality of Life Outcomes 2003, 1. 10.1186/1477-7525-1-41, 212192, 14521718.
61. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983, 385-396. 10.2307/2136404, 6668417.
62. Barsky A, Wyshak G, Klerman G. The somatosensory amplification scale and its relationship to hypochondriasis. J Psychiatr Res 1990, 24:323-334. 10.1016/0022-3956(90)90004-A, 2090830.
63. Scheier M, Carver C, Bridges M. Distinguishing optimism from neurotiscism(and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol 1994, 67:1063-1078. 10.1037/0022-3514.67.6.1063, 7815302.
64. Medical Research Council and Department for Health Joint Project guidance notes on Pharmacovigilance. 2007, Retrieved 13 Jan 2009, Medical Research Council and Department for Health., http://www.ct-toolkit.ac.uk/_db/_documents/Joint_Project_Guidance_on_Pharmacovigilance.pdf
65. Machin D, Fayers P, Pinol A. Sample size tables for clinical studies 1997, Oxford, UK: Blackwell Science.
66. Wampold B, Brown G. Estimating variability in outcomes attributable to therapists: A naturalistic study of outcomes in managed care. J Consult Clin Psychol 2005, 73:914-923. 10.1037/0022-006X.73.5.914, 16287391.
67. Emsley R, Dunn G, White I. Mediation and Moderation of treatment effects in randomised controlled trials of complex interventions. Stat Methods Med Res 2010, 19:237-270. 10.1177/0962280209105014, 19608601.
68. Byrne B. Structural equation modelling with AMOS: Basic concepts, applications, and programming 2001, Mahwah, NJ: Lawrence Erlbaum Associates.