The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors (CCIP)
19. dubna 2016 aktualizováno: Texas Tech University Health Sciences Center
This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured "Change Cycle Work Shop" coping class as compared to current local standard of care programs.
It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences.
Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Breast cancer is the most common cancer among North American women. A combination of screening mammography and improvements in treatment has resulted in a substantial decrease in mortality which explains why more women diagnosed at a younger age are becoming long-term survivors.Consequently, quality of life (QL) issues have become increasingly important in the contemporary multidisciplinary management of breast cancer. Standard of car survivorship program has evolved over several years to include 3 facets: (1)clinical surveillance program to include routine follow up exams; (2) local support group programs; and (3) rehabilitation program offering physical and occupational rehab, along with lymphedema prevention and treatment.
Many studies have reported on successful interventions (listed in our references) with improvements in quality of life; however the effects did not last long after intervention. This has brought into question the real value of such interventions. The proposed class will focus on teaching life skills that have shown long-lasting effect in the corporate world of change. Thus, our goal is to determine if the impact of the class will be similar in the healthcare arena, specifically cancer survivorship. Our last study on assessing quality of life revealed that patients were suffering deficits in quality of life, specifically with regard to the emotional scale despite the standard of care approach available. We therefore propose this intervention to be studied as proof of concept so that depending on the results of the proposed trial, this class can become a routine part of the survivorship program.
Typ studie
Intervenční
Zápis (Aktuální)
120
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Texas
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Amarillo, Texas, Spojené státy, 79106
- Texas Tech University Health Sciences Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- female
- 18 years old or older
- established diagnosis of breast cancer
- diagnosis from January 2010 onward
- must be patient of Texas Tech University Health Sciences Center-Breast Center of Excellence
- must agree to participate in study structure of randomization
Exclusion Criteria:
- those who do not accept randomization
- women with medical conditions that preclude them from attending the coping class
- women with personal issues that preclude them from attending the coping class
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Coping Class
A 4-hour structured program which will be offered once a month as the "Coping Class" by a certified facilitator of "The Change Cycle."
Quality of Life survey completed at 5 time points after informed consent.
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A 4-hour structured program which will be offered once a month as the "Coping Class" by a certified facilitator of "The Change Cycle."
The coping class uses standardized materials and skills training.
Standardized materials for the intervention arm will include "Change Moves Me" Participant's Guide/Journal, Locator Assessment Profile, The Change Cycle Color Model, and class evaluation.
The structure of the class includes a profile of each stage to gain perspective and understanding, teaching personal change skills for each stage and a primary focus for movement to the next stage.
The overall design follows an "act as if" philosophy, guiding participants through each stage of The Change Cycle, irrespective of which stage they are actually in.
The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument.
The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).
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Aktivní komparátor: Standard of Care
Standard of Care.
Three components of this: (1)Surveillance Program, (2)Local support groups centered at community cancer centers, (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation.Quality of Life surveys completed at 5 time points after informed consent.
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The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument.
The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).
Standard of Care.
Three components of this: (1)Surveillance Program: all patients diagnosed with breast cancer are seen every six months for the first two years and yearly thereafter to rule out disease recurrence by history and physical exam at each visit in addition to the annual mammogram.
(2)Local support groups centered at community cancer centers.
These are generally attended by 12-16 women monthly; all breast cancer patients receive the information about these groups.
Associated with these programs, some classes are offered sporadically in nutrition, and exercise.
(3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation to all women, thus provides prevention and treatment of lymphedema and monitored shoulder range of motion.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Quality of Life Questionnaire
Časové okno: Baseline
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Baseline
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Quality of Life Questionnaire
Časové okno: change from Baseline and at 6 months
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change from Baseline and at 6 months
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Quality of Life Questionnaire
Časové okno: change from Baseline and at 12 months
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change from Baseline and at 12 months
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Quality of Life Questionnaire
Časové okno: change from Baseline and at 18 months
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change from Baseline and at 18 months
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Quality of Life Questionnaire
Časové okno: change from Baseline and at 24 months
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change from Baseline and at 24 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Rakhshanda L Rahman, MD, Texas Tech University Health Sciences Center-Amarillo
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
- Allen SM, Shah AC, Nezu AM, Nezu CM, Ciambrone D, Hogan J, Mor V. A problem-solving approach to stress reduction among younger women with breast carcinoma: a randomized controlled trial. Cancer. 2002 Jun 15;94(12):3089-100. doi: 10.1002/cncr.10586.
- Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.
- Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.
- Bloom JR, Stewart SL, Chang S, Banks PJ. Then and now: quality of life of young breast cancer survivors. Psychooncology. 2004 Mar;13(3):147-60. doi: 10.1002/pon.794.
- U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2009.http://www.cdc.gov/uscs.
- http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-and-figures-2010 (accessed on 9/10/2011).
- http://statecancerprofiles.cancer.gov/prevalence/index.php?
- Garfinkel L, Boring CC, Heath CW Jr. Changing trends. An overview of breast cancer incidence and mortality. Cancer. 1994 Jul 1;74(1 Suppl):222-7. doi: 10.1002/cncr.2820741304.
- De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217.
- American Cancer Society. Cancer Facts and Figures 2009. American Cancer society: Atlanta, GA, 2009
- Meyerowitz BE. Psychosocial correlates of breast cancer and its treatments. Psychol Bull. 1980 Jan;87(1):108-31. No abstract available.
- Glanz K, Lerman C. Psychosocial impact of breast cancer: A critical review. Ann Behav Med 14:204-212, 1992
- Ganz PA, Desmond KA, Leedham B, Rowland JH, Meyerowitz BE, Belin TR. Quality of life in long-term, disease-free survivors of breast cancer: a follow-up study. J Natl Cancer Inst. 2002 Jan 2;94(1):39-49. doi: 10.1093/jnci/94.1.39. Erratum In: J Natl Cancer Inst 2002 Mar 20;94(6):463.
- Calman KC. Definitions and dimensions of quality of life. In Quality of life of cancer patients, Aaronson NK, Beckmann J (eds). Raven Press: New York, 1987; 1-10
- Stanton AL, Danoff-Burg S, Cameron CL, Bishop M, Collins CA, Kirk SB, Sworowski LA, Twillman R. Emotionally expressive coping predicts psychological and physical adjustment to breast cancer. J Consult Clin Psychol. 2000 Oct;68(5):875-82.
- McCaul KD, Sandgren AK, King B, O'Donnell S, Branstetter A, Foreman G. Coping and adjustment to breast cancer. Psychooncology. 1999 May-Jun;8(3):230-6. doi: 10.1002/(SICI)1099-1611(199905/06)8:33.0.CO;2-#.
- Schnoll RA, Harlow LL, Stolbach LL, Brandt U. A structural model of the relationships among stage of disease, age, coping, and psychological adjustment in women with breast cancer. Psychooncology. 1998 Mar-Apr;7(2):69-77. doi: 10.1002/(SICI)1099-1611(199803/04)7:23.0.CO;2-8.
- www.changecycle.com
- Kubler-Ross. On Death and Dying: What the Dying Have to Teach Doctors, Nurses, Clergy and their own Families. Simon and Schuster, New York, 1969
- Ellis A. MacLaren C. (1998). Rational-emotive behavior therapy: A therapist's guide. California: Impact publishers
- Piaget, J. and Inhelder, B. (1962). The Psychology of the Child. New York: Basic Books
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- Ellis A (1994). Reason and Emotion in psychotherapy-revised and updated. New York, NY: Birch Lane Press
- Schwartz, B. (2004). The paradox of choice: why more is less. New York: Ecco Press
- Iyengar SS, Lepper MR. When choice is demotivating: can one desire too much of a good thing? J Pers Soc Psychol. 2000 Dec;79(6):995-1006. doi: 10.1037//0022-3514.79.6.995.
- Bridges W. (2003). Managing transitions: Making the most of change. 2nd ed. New York: Da Capo Press
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2012
Primární dokončení (Aktuální)
1. prosince 2015
Dokončení studie (Aktuální)
1. prosince 2015
Termíny zápisu do studia
První předloženo
21. listopadu 2012
První předloženo, které splnilo kritéria kontroly kvality
26. listopadu 2012
První zveřejněno (Odhad)
27. listopadu 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
21. dubna 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. dubna 2016
Naposledy ověřeno
1. dubna 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- A12-3719
Plán pro data jednotlivých účastníků (IPD)
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