Clinical trial NCT02393105: Sense of Hope Alleviates Fatigue in Breast Cancer Survivors
Official title: The Sense of Hope Alleviates Fatigue in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma of Male Breast
Keywords: Breast Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer survivors,complete chemotherapy and radiotherapy

Brief summary: 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.

Detailed description: Breast cancer is an important and escalating issue for females all over the world. Due to the improvement of medical and technological progress, the survival rate of breast cancer patient increases every year. Breast cancer survivors, after the discomforting distress from cancer treatment, will go through treatment-derived physical distress and worry about relapse. As a result the fatigue in breast cancer survivors has not been reduced after primary treatment. Feeling fatigue in a long term will bring mental illness problems ,decrease the quality of life and weaken the will to survive. A sense of hope in the face of fatigue may serve as an important driving force and enhance the survivors' will to survive. 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.

A cross-sectional study design is adopted for this study. The study expects to collect 200 questionnaires from breast cancer survivors through medical centers treating breast cancer and breast cancer patients communities. The questionnaire includes (a) the basic demographic information (b) disease history (c) social support scale; (d) short version multiaxial fatigue syndrome scale; (e) Hearst hope scale.

Answered questionnaires will be input to spreadsheets for further statistical analysis using SPSS 19.0 statistical software packages.

Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Fatigue Symptom Inventory-Short Form
timeFrame: Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy
Secondary outcomes:
measure: Herth Hope Index
timeFrame: Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy
measure: The Inventory of Socially Supportive Behaviors
timeFrame: Baseline measured after the completion of breast cancer surgery, radiation therapy and chemotherapy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: ChunaNG Pei-Hsuan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1002/(sici)1099-1611(199909/10)8:53.0.co;2-4.
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.
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.
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.
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.
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.
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.
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.
citation: Olson K. A new way of thinking about fatigue: a reconceptualization. Oncol Nurs Forum. 2007 Jan;34(1):93-9. doi: 10.1188/07.ONF.93-99.
citation: Piper BF, Cella D. Cancer-related fatigue: definitions and clinical subtypes. J Natl Compr Canc Netw. 2010 Aug;8(8):958-66. doi: 10.6004/jnccn.2010.0070.
citation: Ribi K, Bernhard J, Rufibach K, Thurlimann B, von Moos R, Ruhstaller T, Glaus A, Bohme C. Endocrine symptom assessment in women with breast cancer: what a simple "yes" means. Support Care Cancer. 2007 Dec;15(12):1349-56. doi: 10.1007/s00520-007-0258-3. Epub 2007 May 26.
citation: Rustoen 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.
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.