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The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

Primary Purpose

Lymphedema

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
combined decongestive therapy
pneumatic compression pump
Sponsored by
badri jaafari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema secondary to breast cancer, Breast cancer, Body image

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. histoty of breast cancer,
  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:

  1. psychotic disorder,
  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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CDT and pneumatic compression pump

    not CDT and pneumatic compression pump

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    changes in the body image
    Body image evaluated with the body image and relationships scale. Body image and relationships scale is a questionnaire that consists of 32 items in the three subscales or factors, named strength and health, social barriers, and appearance and sexuality. Higher scores on each subscale indicated greater impairment.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 29, 2015
    Last Updated
    January 7, 2016
    Sponsor
    badri jaafari
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02650297
    Brief Title
    The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema
    Official Title
    The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    badri jaafari

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.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). In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, Combined DecongestiveTherapy 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.
    Detailed Description
    Background: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema
    Keywords
    Lymphedema secondary to breast cancer, Breast cancer, Body image

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CDT and pneumatic compression pump
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    not CDT and pneumatic compression pump
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    combined decongestive therapy
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    pneumatic compression pump
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    changes in the body image
    Description
    Body image evaluated with the body image and relationships scale. Body image and relationships scale is a questionnaire that consists of 32 items in the three subscales or factors, named strength and health, social barriers, and appearance and sexuality. Higher scores on each subscale indicated greater impairment.
    Time Frame
    change from baseline body image at 8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: histoty of breast cancer, history of surgery and chemotherapy and as needed hormone therapy and radiotherapy, affected by lymphedema (with degree of mild to severe) based on specialist diagnosis, at least 1 year ago was undergone axillary node dissection, do not have knowledge about combined decongestive therapy, phone accessibility, 35-70 years old. Exclusion criteria: psychotic disorder, existence sever pain at axillary area, history of hysterectomy duo to uterus cancer, severe cardiac disease, heart failure, renal failure, severe hypertension, existing other malignancies, recurrent infection in arm, musclo skeletal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    badri jaafari, author
    Organizational Affiliation
    Department of Nursing, College of Nursing & Midwifery, Kazeroun Azad University, Kazeroun, Iran
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10987230
    Citation
    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.
    Results Reference
    background
    Citation
    Kaviani A, Lotfi M. Control of lymphedema after breast cancer treatment. 1st ed. Tehran: Tehran university of medical
    Results Reference
    result
    PubMed Identifier
    16184458
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18691823
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18323550
    Citation
    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.
    Results Reference
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    PubMed Identifier
    19534633
    Citation
    Ridner SH. The psycho-social impact of lymphedema. Lymphat Res Biol. 2009;7(2):109-12. doi: 10.1089/lrb.2009.0004.
    Results Reference
    result
    PubMed Identifier
    10971418
    Citation
    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.
    Results Reference
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    PubMed Identifier
    11307660
    Citation
    Foldi M. Lymphology in the second millennium. Lymphology. 2001 Mar;34(1):12-21. No abstract available.
    Results Reference
    result
    PubMed Identifier
    11332311
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23925581
    Citation
    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.
    Results Reference
    result
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    7963764
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18089142
    Citation
    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.
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    PubMed Identifier
    9874404
    Citation
    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.
    Results Reference
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    PubMed Identifier
    19771507
    Citation
    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.
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    PubMed Identifier
    21584214
    Citation
    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.
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    25601235
    Citation
    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.
    Results Reference
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    Links:
    URL
    http://www.tums.ac.ir/faculties/akaviani
    Description
    website
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/16184458
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/18691823
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/18323550
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/11307660
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC80678/
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23925581
    Description
    Text Link
    URL
    http://connection.ebscohost.com/c/articles/25178700/effectiveness-exercise-compression-garments-treatment-breast-cancer-related-lymphedema
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/7963764
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/18089142
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/9874404
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/19771507
    Description
    Text Link
    URL
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3089917/
    Description
    Text Link

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    The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

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