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NCT Number: NCT02650297

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

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.

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Key information

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined decongestive therapy

Other

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

Device

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 outcomes

  1. changes in the body image

    Time frame: change from baseline body image at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

badri jaafari

Other

Registry information

Official study title

The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2016
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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