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Completed

NCT Number: NCT00769821

The Impact of Lymphedema on Breast Cancer Survivors

RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco School of Nursing

San Francisco, California, 94115, United States

About this study

OBJECTIVES:

  • To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, and local upper extremity functioning.
  • To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, and overall health-related functioning.
  • To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, overall health-related functioning, and quality of life.

OUTLINE: Patients are stratified according to presence of lymphedema (yes vs no).

Patients complete self-reporting questionnaires to assess the degree of lymphedema using the Norman Questionnaire and Jane M. Armer's Lymphedema and Breast Cancer Questionnaire; lymphedema-associated symptoms using Symptoms in the Affected Breast/Mastectomy site questionnaire, Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire, and General Symptom Experience questionnaire; local upper extremity functioning using hand dominance questionnaire and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; quality of life (QOL) using the Multidimensional QOL Scale; and comorbidity using the Charleston Comorbidity Scale. Patients undergo a 3.5-hour testing to assess the degree of lymphedema by arm circumference and bioimpedance spectroscopy (BIS); local upper extremity functioning by strength testing, range of movement and neurodynamic testing using a goniometer, a skin examination, skin sensation and sensation at scar using the Semmes-Weinstein Monofilament test, and fine motor control/finger coordination using the Purdue Pegboard, Finger Tapper, and Vibration Threshold; and overall health-related functioning using a graded exercise test.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • No breast cancer on both sides
  • No recurrence of breast cancer (local or distant)
  • Completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months
  • No prior contralateral or bilateral mastectomy
  • No pre-existing lymphedema prior to breast cancer diagnosis
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Weight < 300 pounds
  • Mentally and physically able to participate
  • No current infection or lymphangitis involving the affected arm
  • No pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning
  • No contraindications to bioimpedance spectroscopy (BIS) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound)
  • No contraindications to exercise testing as outlined by the American Heart Association and the American College of Sports Medicine

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

Questionnaire Administration

Other

assessment of therapy complications

Procedure

bioimpedance spectroscopy

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS)

    Time frame: study visit approximately 5 hours

  2. Lymphedema-associated symptoms by Symptoms in the Affected Breast/Mastectomy site questionnaire; Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire; and General Symptom Experience questionnaire

    Time frame: study visit approximately 5 hours

  3. Local upper extremity function by tests & questionnaires (e.g., hand dominance; strength; range of motion & neurodynamics; fine motor control/finger coordination; skin exam; skin & scar sensation [Semmes-Weinstein Monofilament])

    Time frame: study visit approximately 5 hours

  4. Overall health-related functioning as assessed by Medical Outcomes Study-Short Form 36 (MOS-SF36), graded exercise test using a treadmill stress test, and cardio-respiratory fitness using peak VO2

    Time frame: study visit approximately 5 hours

  5. Quality of life (QOL) as assessed by Multidimensional QOL Scale

    Time frame: study visit approximately 5 hours

  6. Comorbidity as assessed by Charleston Comorbidity Scale

    Time frame: study visit approximately 5 hours

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Impact of Lymphedema on Local and Overall Functioning

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 9, 2008
Registry last updated
Dec 12, 2012

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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