Carcinoma of Male Breast Clinical Trial
Official title:
The Sense of Hope Alleviates Fatigue in Breast Cancer Survivors
This study explores the relationship between the sense of hope and fatigue in breast cancer survivors and provides a reference for future planning improvements for breast cancer survivors experiencing fatigue.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 90 Years |
| Eligibility |
Inclusion criteria: 1. diagnosed as a breast cancer patient 2. complete operation,chemotherapy and radiation therapy 3. understand the treatment and condition by herself 4. conscious clear who can speaking Mandarin or: Taiwanese 5. after consenting , the participant agree to participate orally or write down in the consent form Exclusion criteria: 1. Can not speaking Mandarin or Taiwanese 2. Psychotic or Understanding barriers 3. refuse verbally or write the Consent Form |
Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
Alexander S, Minton O, Andrews P, Stone P. A comparison of the characteristics of disease-free breast cancer survivors with or without cancer-related fatigue syndrome. Eur J Cancer. 2009 Feb;45(3):384-92. doi: 10.1016/j.ejca.2008.09.010. Epub 2008 Oct 30. — View Citation
Berger AM, Gerber LH, Mayer DK. Cancer-related fatigue: implications for breast cancer survivors. Cancer. 2012 Apr 15;118(8 Suppl):2261-9. doi: 10.1002/cncr.27475. Review. — View Citation
Brady MJ, Peterman AH, Fitchett G, Mo M, Cella D. A case for including spirituality in quality of life measurement in oncology. Psychooncology. 1999 Sep-Oct;8(5):417-28. — View Citation
Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. — View Citation
Gielissen MF, Wiborg JF, Verhagen CA, Knoop H, Bleijenberg G. Examining the role of physical activity in reducing postcancer fatigue. Support Care Cancer. 2012 Jul;20(7):1441-7. doi: 10.1007/s00520-011-1227-4. Epub 2011 Jul 21. — View Citation
Goldstein D, Bennett BK, Webber K, Boyle F, de Souza PL, Wilcken NR, Scott EM, Toppler R, Murie P, O'Malley L, McCourt J, Friedlander M, Hickie IB, Lloyd AR. Cancer-related fatigue in women with breast cancer: outcomes of a 5-year prospective cohort study. J Clin Oncol. 2012 May 20;30(15):1805-12. doi: 10.1200/JCO.2011.34.6148. Epub 2012 Apr 16. — View Citation
Hoffman AJ, von Eye A, Gift AG, Given BA, Given CW, Rothert M. Testing a theoretical model of perceived self-efficacy for cancer-related fatigue self-management and optimal physical functional status. Nurs Res. 2009 Jan-Feb;58(1):32-41. doi: 10.1097/NNR.0b013e3181903d7b. — View Citation
Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Mar 7;104(5):386-405. doi: 10.1093/jnci/djr541. Epub 2012 Jan 23. Review. — View Citation
Koch L, Jansen L, Herrmann A, Stegmaier C, Holleczek B, Singer S, Brenner H, Arndt V. Quality of life in long-term breast cancer survivors - a 10-year longitudinal population-based study. Acta Oncol. 2013 Aug;52(6):1119-28. doi: 10.3109/0284186X.2013.774461. Epub 2013 Mar 20. — View Citation
Mattioli JL, Repinski R, Chappy SL. The meaning of hope and social support in patients receiving chemotherapy. Oncol Nurs Forum. 2008 Sep;35(5):822-9. doi: 10.1188/08.ONF.822-829. — View Citation
Olson K. A new way of thinking about fatigue: a reconceptualization. Oncol Nurs Forum. 2007 Jan;34(1):93-9. Review. — View Citation
Piper BF, Cella D. Cancer-related fatigue: definitions and clinical subtypes. J Natl Compr Canc Netw. 2010 Aug;8(8):958-66. — View Citation
Ribi K, Bernhard J, Rufibach K, Thürlimann B, von Moos R, Ruhstaller T, Glaus A, Böhme C. Endocrine symptom assessment in women with breast cancer: what a simple "yes" means. Support Care Cancer. 2007 Dec;15(12):1349-56. Epub 2007 May 26. — View Citation
Rustøen T, Cooper BA, Miaskowski C. The importance of hope as a mediator of psychological distress and life satisfaction in a community sample of cancer patients. Cancer Nurs. 2010 Jul-Aug;33(4):258-67. doi: 10.1097/NCC.0b013e3181d6fb61. — View Citation
Trudel-Fitzgerald C, Savard J, Ivers H. Evolution of cancer-related symptoms over an 18-month period. J Pain Symptom Manage. 2013 Jun;45(6):1007-18. doi: 10.1016/j.jpainsymman.2012.06.009. Epub 2012 Sep 24. — View Citation
* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Multidimensional Fatigue Symptom Inventory-Short Form | A 30-item self-report questionnaire designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. | Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy | No |
| Secondary | Herth Hope Index | A 12-item self-report questionnaire containing three dimensions: temporality and future, positive readiness and expectancy, and interconnectedness. Tested on family caregivers of terminally ill people and terminally ill persons as well as in community and hospital patients and family members. (Herth, 1990) | Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy | No |
| Secondary | The Inventory of Socially Supportive Behaviors | A 40-item self-report questionnaire designed to assess how often individuals received various forms of assistance during the preceding month, such as directive guidance (e.g., offering advice), nondirective support (e.g., listening and reflecting), positive social exchange (e.g., expressing confidence and encouragement), and tangible assistance (e.g., providing materials or services). (Barrera, Sandler, & Ramsay, 1981). | Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy | No |