The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema
NCT ID: NCT02650297
Last Updated: 2016-01-08
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2009-10-31
2009-12-31
Brief Summary
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Detailed Description
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Lymphedema is a common complication for breast cancer therapy. Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.
methods: 42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). A certified nurse worked on Combined Decongestive Therapy in the intervention group in two phases. In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, CDT was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CDT and pneumatic compression pump
combined decongestive therapy consists of the pressure of bandage, manual lymphatic drainage, and exercises that increase the flow of lymph and skin care are used. Intermittent pneumatic pump is not as a part of CDT, but it can be used as an adjunct method. This device according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk.
combined decongestive therapy
Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.
pneumatic compression pump
Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk
not CDT and pneumatic compression pump
Patients in the control group received no treatment for lymphedema but were placed on the waiting list for CDT as soon as possible after the 8 weeks follow-up period.
No interventions assigned to this group
Interventions
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combined decongestive therapy
Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.
pneumatic compression pump
Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk
Eligibility Criteria
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Inclusion Criteria
2. history of surgery and chemotherapy and as needed hormone therapy and radiotherapy,
3. affected by lymphedema (with degree of mild to severe) based on specialist diagnosis,
4. at least 1 year ago was undergone axillary node dissection,
5. do not have knowledge about combined decongestive therapy,
6. phone accessibility,
7. 35-70 years old.
Exclusion Criteria
2. existence sever pain at axillary area,
3. history of hysterectomy duo to uterus cancer,
4. severe cardiac disease,
5. heart failure,
6. renal failure,
7. severe hypertension,
8. existing other malignancies,
9. recurrent infection in arm,
10. musclo skeletal disease
35 Years
70 Years
FEMALE
No
Sponsors
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badri jaafari
OTHER
Responsible Party
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badri jaafari
faculty member of IAUKazeroun
Principal Investigators
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badri jaafari, author
Role: STUDY_CHAIR
Department of Nursing, College of Nursing & Midwifery, Kazeroun Azad University, Kazeroun, Iran
References
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Isaksson G, Feuk B. Morbidity from axillary treatment in breast cancer--a follow-up study in a district hospital. Acta Oncol. 2000;39(3):335-6. doi: 10.1080/028418600750013104. No abstract available.
Kaviani A, Lotfi M. Control of lymphedema after breast cancer treatment. 1st ed. Tehran: Tehran university of medical
Didem K, Ufuk YS, Serdar S, Zumre A. The comparison of two different physiotherapy methods in treatment of lymphedema after breast surgery. Breast Cancer Res Treat. 2005 Sep;93(1):49-54. doi: 10.1007/s10549-005-3781-2.
Nielsen I, Gordon S, Selby A. Breast cancer-related lymphoedema risk reduction advice: a challenge for health professionals. Cancer Treat Rev. 2008 Nov;34(7):621-8. doi: 10.1016/j.ctrv.2007.11.002. Epub 2008 Aug 8.
Hormes JM, Lytle LA, Gross CR, Ahmed RL, Troxel AB, Schmitz KH. The body image and relationships scale: development and validation of a measure of body image in female breast cancer survivors. J Clin Oncol. 2008 Mar 10;26(8):1269-74. doi: 10.1200/JCO.2007.14.2661.
Ridner SH. The psycho-social impact of lymphedema. Lymphat Res Biol. 2009;7(2):109-12. doi: 10.1089/lrb.2009.0004.
Pain SJ, Purushotham AD. Lymphoedema following surgery for breast cancer. Br J Surg. 2000 Sep;87(9):1128-41. doi: 10.1046/j.1365-2168.2000.01569.x.
Foldi M. Lymphology in the second millennium. Lymphology. 2001 Mar;34(1):12-21. No abstract available.
Harris SR, Hugi MR, Olivotto IA, Levine M; Steering Committee for Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001 Jan 23;164(2):191-9.
Uzkeser H, Karatay S, Erdemci B, Koc M, Senel K. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. 2015 May;22(3):300-7. doi: 10.1007/s12282-013-0481-3. Epub 2013 Aug 8.
Irdesel J, Celiktas SK. Effectiveness of exercise and compression garments in the treatment of breast cancer related lymphedema- Original article. Turk J Phys Med Rehab, 2007;53:16-21.
Passik S, Newman M, Brennan M, Holland J. Psychiatric consultation for women undergoing rehabilitation for upper-extremity lymphedema following breast cancer treatment. J Pain Symptom Manage. 1993 May;8(4):226-33. doi: 10.1016/0885-3924(93)90132-f.
Pruzinsky T. Enhancing quality of life in medical populations: a vision for body image assessment and rehabilitation as standards of care. Body Image. 2004 Jan;1(1):71-81. doi: 10.1016/S1740-1445(03)00010-X.
Passik SD, McDonald MV. Psychosocial aspects of upper extremity lymphedema in women treated for breast carcinoma. Cancer. 1998 Dec 15;83(12 Suppl American):2817-20. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-2.
Speck RM, Gross CR, Hormes JM, Ahmed RL, Lytle LA, Hwang WT, Schmitz KH. Changes in the Body Image and Relationship Scale following a one-year strength training trial for breast cancer survivors with or at risk for lymphedema. Breast Cancer Res Treat. 2010 Jun;121(2):421-30. doi: 10.1007/s10549-009-0550-7. Epub 2009 Sep 22.
Poorkiani M, Abbaszadeh A, Hazrati M, Jafari P, Sadeghi M, Mohammadianpanah M. The effect of rehabilitation on quality of life in female breast cancer survivors in Iran. Indian J Med Paediatr Oncol. 2010 Oct;31(4):105-9. doi: 10.4103/0971-5851.76190.
Teo I, Novy DM, Chang DW, Cox MG, Fingeret MC. Examining pain, body image, and depressive symptoms in patients with lymphedema secondary to breast cancer. Psychooncology. 2015 Nov;24(11):1377-83. doi: 10.1002/pon.3745. Epub 2015 Jan 20.
Related Links
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Other Identifiers
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IAUKazeroun
Identifier Type: -
Identifier Source: org_study_id
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