Breast Cancer Clinical Trial
Official title:
Improving Emotion Regulation at the End of Breast Cancer Treatment: A Randomized Controlled Study Assessing the Impact of a Multi-Component Psychological Group Intervention
Verified date | December 2020 |
Source | Université Libre de Bruxelles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The end of treatment marks the beginning of a challenging period for breast cancer patients. While this period often provokes a sense of relief, it can also be a source of apprehension and vulnerability regarding the future. Patients may be brought to feel contradictory thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty and fear of cancer recurrence. In order to accompany breast cancer patients during this transition period and to address these emotional difficulties, the Institut Jules Bordet has launched an 8-session psychological multi-component group intervention. Its objective is to bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts, learning to cope with uncertainty, attention reorientation toward positive thoughts) to promote emotion management and well-being.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Experiencing moderate to high emotion dysregulation (one to four scores = or > 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts) - Non-metastatic breast cancer - Post chimiotherapy, radiotherapy, surgery treatment - Age > 18 years - Completing a written informed consent Exclusion Criteria: - Male - Non-fluency in French - Severe cognitive impairment - Severe and/or acute psychiatric disorder. |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Libre de Bruxelles | Centre de Psycho-Oncologie (CPO), Jules Bordet Institute |
Belgium,
Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients' supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009 Dec 20;27(36):6172-9. doi: 10.1200/JCO.2009.22.5151. Epub 2009 Nov 2. — View Citation
Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29. — View Citation
Baker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. — View Citation
Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IJzendoorn MH. Threat-related attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull. 2007 Jan;133(1):1-24. — View Citation
Berking, M., & Schwarz, J. (2013). Affect regulation training. Handbook of Emotion Regulation. New York: Guilford.
Björneklett HG, Lindemalm C, Rosenblad A, Ojutkangas ML, Letocha H, Strang P, Bergkvist L. A randomised controlled trial of support group intervention after breast cancer treatment: results on anxiety and depression. Acta Oncol. 2012 Feb;51(2):198-207. doi: 10.3109/0284186X.2011.610352. Epub 2011 Sep 19. — View Citation
Borkovec, T.D., et al. (1998). Worry: a cognitive phenomenon intimately linked to affective, physiological, and interpersonal behavioral processes. Cognitive Therapy and Research, 22(6), 561-576.
Chambless DL, Ollendick TH. Empirically supported psychological interventions: controversies and evidence. Annu Rev Psychol. 2001;52:685-716. — View Citation
Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. — View Citation
Costanzo ES, Lutgendorf SK, Mattes ML, Trehan S, Robinson CB, Tewfik F, Roman SL. Adjusting to life after treatment: distress and quality of life following treatment for breast cancer. Br J Cancer. 2007 Dec 17;97(12):1625-31. Epub 2007 Nov 13. — View Citation
Davey HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007 Apr;60(4):356-60. Epub 2006 Dec 27. — View Citation
Deacon BJ, Abramowitz JS. Cognitive and behavioral treatments for anxiety disorders: a review of meta-analytic findings. J Clin Psychol. 2004 Apr;60(4):429-41. — View Citation
Devine EC, Westlake SK. The effects of psychoeducational care provided to adults with cancer: meta-analysis of 116 studies. Oncol Nurs Forum. 1995 Oct;22(9):1369-81. — View Citation
DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. — View Citation
Dolbeault S, Cayrou S, Brédart A, Viala AL, Desclaux B, Saltel P, Gauvain-Piquard A, Hardy P, Dickes P. The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study. Psychooncology. 2009 Jun;18(6):647-56. doi: 10.1002/pon.1440. — View Citation
Duijts SF, Faber MM, Oldenburg HS, van Beurden M, Aaronson NK. Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors--a meta-analysis. Psychooncology. 2011 Feb;20(2):115-26. doi: 10.1002/pon.1728. Review. — View Citation
Duijts SF, van Beurden M, Oldenburg HS, Hunter MS, Kieffer JM, Stuiver MM, Gerritsma MA, Menke-Pluymers MB, Plaisier PW, Rijna H, Lopes Cardozo AM, Timmers G, van der Meij S, van der Veen H, Bijker N, de Widt-Levert LM, Geenen MM, Heuff G, van Dulken EJ, Boven E, Aaronson NK. Efficacy of cognitive behavioral therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: results of a randomized, controlled, multicenter trial. J Clin Oncol. 2012 Nov 20;30(33):4124-33. doi: 10.1200/JCO.2012.41.8525. Epub 2012 Oct 8. — View Citation
Elsesser, K., Van Berkel, M., & Sartory, G. (1994). The effects of anxiety management training on psychological variables and immune parameters in cancer patients. Behavioural and Cognitive Psychotherapy, 22, 13-23.
Falagas ME, Zarkadoulia EA, Ioannidou EN, Peppas G, Christodoulou C, Rafailidis PI. The effect of psychosocial factors on breast cancer outcome: a systematic review. Breast Cancer Res. 2007;9(4):R44. — View Citation
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. — View Citation
Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6. Review. — View Citation
Fredrickson BL, Losada MF. Positive affect and the complex dynamics of human flourishing. Am Psychol. 2005 Oct;60(7):678-86. Erratum in: Am Psychol. 2013 Dec;68(9):822. — View Citation
Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. — View Citation
Friedman BH. An autonomic flexibility-neurovisceral integration model of anxiety and cardiac vagal tone. Biol Psychol. 2007 Feb;74(2):185-99. Epub 2006 Oct 27. Review. — View Citation
Hammond DC. Hypnosis in the treatment of anxiety- and stress-related disorders. Expert Rev Neurother. 2010 Feb;10(2):263-73. doi: 10.1586/ern.09.140. Review. — View Citation
Harrison SE, Watson EK, Ward AM, Khan NF, Turner D, Adams E, Forman D, Roche MF, Rose PW. Primary health and supportive care needs of long-term cancer survivors: a questionnaire survey. J Clin Oncol. 2011 May 20;29(15):2091-8. doi: 10.1200/JCO.2010.32.5167. Epub 2011 Apr 25. — View Citation
Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G. Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Cancer. 2010 Apr;18(4):471-9. doi: 10.1007/s00520-009-0696-1. Epub 2009 Oct 29. — View Citation
Hidderley M, Holt M. A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses. Eur J Oncol Nurs. 2004 Mar;8(1):61-5. — View Citation
Hopwood P, Sumo G, Mills J, Haviland J, Bliss JM; START Trials Management Group. The course of anxiety and depression over 5 years of follow-up and risk factors in women with early breast cancer: results from the UK Standardisation of Radiotherapy Trials (START). Breast. 2010 Apr;19(2):84-91. doi: 10.1016/j.breast.2009.11.007. Epub 2009 Dec 29. — View Citation
Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751. Review. — View Citation
Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16. Review. — View Citation
Jermann, F., et al. (2006). Cognitive Emotion Regulation Questionnaire (CERQ): Confirmatory Factor Analysis and Psychometric Properties of the French Translation. European Journal of Psychological Assessment, 22, 126-131.
Kastenbaum, R. (2000). The psychology of death (3rd ed.). New York: Springer.
Killingsworth MA, Gilbert DT. A wandering mind is an unhappy mind. Science. 2010 Nov 12;330(6006):932. doi: 10.1126/science.1192439. — View Citation
Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. — View Citation
Kirsch I, Montgomery G, Sapirstein G. Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis. J Consult Clin Psychol. 1995 Apr;63(2):214-20. — View Citation
Lang PJ, Davis M, Ohman A. Fear and anxiety: animal models and human cognitive psychophysiology. J Affect Disord. 2000 Dec;61(3):137-59. Review. — View Citation
Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23. — View Citation
Lebel S, Rosberger Z, Edgar L, Devins GM. Comparison of four common stressors across the breast cancer trajectory. J Psychosom Res. 2007 Sep;63(3):225-32. Epub 2007 Aug 2. — View Citation
Lebel S, Rosberger Z, Edgar L, Devins GM. Emotional distress impacts fear of the future among breast cancer survivors not the reverse. J Cancer Surviv. 2009 Jun;3(2):117-27. doi: 10.1007/s11764-009-0082-5. Epub 2009 Mar 26. — View Citation
Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529. — View Citation
Llewellyn CD, Weinman J, McGurk M, Humphris G. Can we predict which head and neck cancer survivors develop fears of recurrence? J Psychosom Res. 2008 Dec;65(6):525-32. doi: 10.1016/j.jpsychores.2008.03.014. Epub 2008 Sep 24. — View Citation
Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Liénard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7. — View Citation
Merckaert, I., et al. (2016). Emotion regulation at the beginning of the survivorship period for breast cancer: Comparing the impact of an 8-session to a 15-session multicomponent group intervention, submitted abstract. Psychooncology.
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. — View Citation
Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J. 1993 Mar;13(1):15-24. Review. — View Citation
Mishel MH, Germino BB, Gil KM, Belyea M, Laney IC, Stewart J, Porter L, Clayton M. Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005 Nov;14(11):962-78. — View Citation
Montazeri A, Jarvandi S, Haghighat S, Vahdani M, Sajadian A, Ebrahimi M, Haji-Mahmoodi M. Anxiety and depression in breast cancer patients before and after participation in a cancer support group. Patient Educ Couns. 2001 Dec 1;45(3):195-8. — View Citation
Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. — View Citation
Naaman SC, Radwan K, Fergusson D, Johnson S. Status of psychological trials in breast cancer patients: a report of three meta-analyses. Psychiatry. 2009 Spring;72(1):50-69. doi: 10.1521/psyc.2009.72.1.50. Review. — View Citation
Norton PJ, Price EC. A meta-analytic review of adult cognitive-behavioral treatment outcome across the anxiety disorders. J Nerv Ment Dis. 2007 Jun;195(6):521-31. — View Citation
Osborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatry Med. 2006;36(1):13-34. Review. — View Citation
Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P. The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer. 2000 Jan 1;88(1):226-37. — View Citation
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. — View Citation
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part II: Immunologic effects. J Clin Oncol. 2005 Sep 1;23(25):6097-106. — View Citation
Scheier MF, Helgeson VS, Schulz R, Colvin S, Berga S, Bridges MW, Knapp J, Gerszten K, Pappert WS. Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. J Clin Oncol. 2005 Jul 1;23(19):4298-311. — View Citation
Schmidt RE, Gay P, Courvoisier D, Jermann F, Ceschi G, David M, Brinkmann K, Van der Linden M. Anatomy of the White Bear Suppression Inventory (WBSI): a review of previous findings and a new approach. J Pers Assess. 2009 Jul;91(4):323-30. doi: 10.1080/00223890902935738. Review. — View Citation
Sheard T, Maguire P. The effect of psychological interventions on anxiety and depression in cancer patients: results of two meta-analyses. Br J Cancer. 1999 Aug;80(11):1770-80. — View Citation
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. Review. — View Citation
Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15. — View Citation
Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10. Review. — View Citation
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. — View Citation
Stanton AL, Ganz PA, Rowland JH, Meyerowitz BE, Krupnick JL, Sears SR. Promoting adjustment after treatment for cancer. Cancer. 2005 Dec 1;104(11 Suppl):2608-13. — View Citation
Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. Review. — View Citation
Stark DP, House A. Anxiety in cancer patients. Br J Cancer. 2000 Nov;83(10):1261-7. Review. — View Citation
Stewart RE, Chambless DL. Cognitive-behavioral therapy for adult anxiety disorders in clinical practice: a meta-analysis of effectiveness studies. J Consult Clin Psychol. 2009 Aug;77(4):595-606. doi: 10.1037/a0016032. — View Citation
Traeger L, Greer JA, Fernandez-Robles C, Temel JS, Pirl WF. Evidence-based treatment of anxiety in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1197-205. doi: 10.1200/JCO.2011.39.5632. Epub 2012 Mar 12. Review. — View Citation
Visser MR, Smets EM. Fatigue, depression and quality of life in cancer patients: how are they related? Support Care Cancer. 1998 Mar;6(2):101-8. — View Citation
Watson M, Greer S, Young J, Inayat Q, Burgess C, Robertson B. Development of a questionnaire measure of adjustment to cancer: the MAC scale. Psychol Med. 1988 Feb;18(1):203-9. — View Citation
Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. — View Citation
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. Review. — View Citation
Würtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19. — View Citation
Zebrack BJ, Ganz PA, Bernaards CA, Petersen L, Abraham L. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006 May;15(5):407-21. — View Citation
Zelenski, J. M., & Larsen, R. J. (2000). The Distribution of Basic Emotions in Everyday Life: A State and Trait Perspective from Experience Sampling Data. Journal of Research in Personality, 34(2), 178-197.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation
* Note: There are 75 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Patients' Subjective Emotion Regulation through six 10-cm visual analog scales assessing anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels | Change in patients' subjective emotion regulation will be examined using the Emotion Regulation Task. Patients are asked to self-report their anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels just after both exposures to anxiety triggers (the Mental Adjustment to Cancer Scale (MAC)) and the Impact of Cancer questionnaire Version 2 (IOCv2)) and regulation exercises (self-relaxation and induced relaxation) using six 10-cm visual analog scales (VAS; with the extreme left defined as "not at all" and the extreme right defined as "extremely"). VAS are used because such scales have been shown to be appropriate and adequate for the assessment of emotional states (Davey et al., 2007; Wewers & Lowe, 1990). | Change from T1 (baseline) Patients' Subjective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Patients' Subjective Emotion Regulation at T3 (4 months after T2) for the CG | |
Primary | Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute) | Change in patients' objective emotion regulation will be examined using the Emotion Regulation Task. Heart rate (beats per minute) is measured throughout the Emotion Regulation Task using an ambulatory digital Holter recorder. | Change from T1 (baseline) Patients' Objective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 monts after T2) for the EG; Change from T2 Patients' Objective Emotion Regulation at T3 (4 monts after T2) for the CG | |
Primary | Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment | Change in patients' emotion regulation in their everyday life will be assessed through an ecological momentary assessment (EMA) procedure during 7 days. The EMA procedure will allow to observe the evolution of the ratio between positive and negative emotions in patients' everyday life (Fredrickson & Losada, 2005). | Change from T1 (baseline) Emotion Regulation in their Everyday Life at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Emotion Regulation in their Everyday Life at T3 (4 months after T2) for the CG | |
Primary | Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ) | Change in patients' emotional state will be assessed in terms of anxiety:
Anxiety is assessed by the Hospital Anxiety Depression Scale (HADS) - anxiety 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder. Anxiety is also assessed by the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry. |
Change from T1 (baseline) Anxiety State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Anxiety State at T3 (4 months after T2) for the CG | |
Primary | Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS) | Change in patients' emotional state will be assessed in terms of depression:
Depression is assessed by the Hospital Anxiety Depression Scale - depression 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder. |
Change from T1 (baseline) Depression State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Depression State at T3 (4 months after T2) for the CG | |
Primary | Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI) | Change in patients' emotional state will be assessed in terms of fear of cancer recurrence: Fear of cancer recurrence is assessed by the Fear of Cancer Recurrence Inventory (FCRI). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence. | Change from T1 (baseline) Fear of Cancer Recurrence State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Fear of Cancer Recurrence State at T3 (4 months after T2) for the CG | |
Secondary | Change in an adapted Emotion Symptom Assessment Scale (ESAS) | Patients will complete a self-report adapted Emotion Symptom Assessment Scale (ESAS) assessing from 0 to 10 their usual emotional and symptomatic states (i.e., pain, physical fatigue, psychological fatigue, sleeping difficulties, memory disorder, concentration disorder, feeling of discomfort, hot flushes, depression, anxiety, fear of cancer recurrence, and ruminations). | Change from T1 (baseline) ESAS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ESAS at T3 (4 months after T2) for the CG | |
Secondary | Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire | Patients will complete the Hospital Anxiety and Depression Scale (HADS) - anxiety and depression 14-item ordinal self-report subscales (Zigmond & Snaith, 1983). Each item is scored from 0 to 3. The total score ranges from 0 to 42. A total score from 0 to 12 is considered as normal, from 13 to 18 as an adaptation disorder, and from 19 to 42 as a mood disorder. | Change from T1 (baseline) HADS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 HADS at T3 (4 months after T2) for the CG | |
Secondary | Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire | Patients will complete the Fear of Cancer Recurrence Inventory (FCRI) (Simard & Savard, 2009). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence. | Change from T1 (baseline) FCRI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FCRI at T3 (4 months after T2) for the CG | |
Secondary | Change in the White Bear Suppression Inventory (WBSI) | Patients will complete the White Bear Suppression Inventory (WBSI) (Schmidt et al., 2009 ; Wegner & Zanakos, 1994). The WBSI is a 15-item ordinal self-report measure of thought suppression. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater tendencies to suppress thoughts. | Change from T1 (baseline) WBSI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 WBSI at T3 (4 months after T2) for the CG | |
Secondary | Change in the Mental Adjustment to Cancer Scale (MAC) | Patients will complete the Mental Adjustment to Cancer Scale (MAC) (Watson et al., 1988). The MAC is a 40-item ordinal self-report ordinal measure of five psychological dimensions of mental adjustment in cancer patients (fighting spirit, anxious preoccupation, helpless-hopelessness, fatalism, and avoidance). Each item is scored from 1 (definitely does not apply to me) to 4 (definitely applies to me). | Change from T1 (baseline) MAC at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MAC at T3 (4 months after T2) for the CG | |
Secondary | Change in Penn State Worry Questionnaire (PSWQ) | Patients will complete the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry. | Change from T1 (baseline) PSWQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 PSWQ at T3 (4 months after T2) for the CG | |
Secondary | Change in the Five Facet of Mindfulness Questionnaire (FFMQ) | Patients will complete the Five Facet of Mindfulness Questionnaire (FFMQ) (Baer et al., 2008). The FFMQ is 39-item ordinal self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Each item is scored from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating more mindfulness. | Change from T1 (baseline) FFMQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FFMQ at T3 (4 months after T2) for the CG | |
Secondary | Change in the Metacognitions About Health Anxiety Questionnaire (MCQ-30) | Patients will complete the Metacognitions About Health Anxiety Questionnaire (MCQ-30) (Wells & Cartwright-Hatton, 2004). The MCQ-30 is a 30-item self-report measure of metacognitive beliefs (beliefs about thinking). The MCQ-30 have five subscales: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about the need to control thoughts. Each item is scored from 1 (do not agree) to 4 (agree very much). Subscale scores range from 6 to 24, and total scores range from 30 to 120, with higher scores indicating higher levels of unhelpful metacognitions. | Change from T1 (baseline) MCQ-30 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MCQ-30 at T3 (4 months after T2) for the CG | |
Secondary | Change in the Insomnia Severity Index (ISI) | Patients will complete the Insomnia Severity Index (ISI) (Morin et al., 2011). The ISI is a brief 7-item self-report measure of insomnia. A total score from 0 to 7 is considered as no clinically significant insomnia, from 8 to 14 as a subthreshold insomnia, from 15 to 21 as a moderate clinical insomnia, and from 22 to 28 as a severe clinical insomnia. | Change from T1 (baseline) ISI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ISI at T3 (4 months after T2) for the CG | |
Secondary | Change in the Impact of Cancer Scale (IOCv2) | Patients will complete the Impact of Cancer Scale (IOCv2) (Zebrack et al., 2006). The IOCv2 is a 37-item self-report measure of the quality of life of long-term cancer survivorship. The IOCv2 consists of two higher-order scales, a Positive Impact Scale and a Negative Impact Scale, each with four subscales: Altruism and empathy, health awareness, meaning of cancer, and positive self-evaluation subscales for the Positive Impact Scale, and appearance concerns, body change concerns, life interferences, and worry subscales for the Negative Impact Scale. The IOCv2 also have three additional subscales measuring employment and relationship impacts. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). A higher score on a subscale/scale implies stronger endorsement of that content area. | Change from T1 (baseline) IOCv2 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 IOCv2 at T3 (4 months after T2) for the CG | |
Secondary | Change in the Cognitive Emotion Regulation Questionnaire (CERQ) | Patients will complete the Cognitive Emotion Regulation Questionnaire (CERQ) (Jermann et al., 2006). The CERQ is a 36-item self-report measure of cognitive emotion regulation strategies someone uses after having experienced negative events or situations. The CERQ distinguishes 9 cognitive coping strategie: Self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophizing, and other-blame. Each item is scored from 1 ((almost) never) to 5 (always). The higher the score on a subscale, the more the patient uses this cognitive coping strategy. | Change from T1 (baseline) CERQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 CERQ at T3 (4 months after T2) for the CG | |
Secondary | Change in the Multidimensional Fatigue Inventory (MFI-20) | Patients will complete the Multidimensional Fatigue Inventory (MFI-20) (Smets et al., 1995). The MFI-20 is a 20-item self-report measure of fatigue which covers the five following dimensions: General fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating greater fatigue. | Change from T1 (baseline) MFI-20 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MFI-20 at T3 (4 months after T2) for the CG | |
Secondary | Change in a Life Event Questionnaire | Patients will complete a life event questionnaire assessing hours of physical activity practice, hours of sleep, drugs use, cafeine, theine and alcohol intake, psychogical background, and health care use. | Change from T1 (baseline) Life Event Questionnaire at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Life Event Questionnaire at T3 (4 months after T2) for the CG | |
Secondary | Change in Ecological Momentary Assessment through the use of a pedometer and a measure of cardio frequency (Garmin vívoactive® HR) | Patients are provided with an armband (Garmin vívoactive® HR) to continuously record during nine days (two days of test and seven days of assessment), their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns. | Change from T1 (baseline) Heart Rate, Physical Activiy and Sleep Patterns at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Ecological Momentary Assessment at T3 (4 months after T2) for the CG | |
Secondary | Change in Attentional Bias through a dot probe task | The attentional dot probe computer task will provide a dynamic picture of patients' attentional orientation. | Change from T1 (baseline) Attentional Bias at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Attentional Bias at T3 (4 months after T2) for the CG |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |