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Behavioral Intervention

Quality-of-Life Assessment for Lymphedema

N/A
Waitlist Available
Led By Sherry Hite
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 4 weeks
Awards & highlights

Study Summary

This trial is studying how well the Remotivation Process works in improving adherence to lymphedema treatment programs in patients with breast cancer-related lymphedema.

Eligible Conditions
  • Lymphedema
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper arm
Change in daily performance of the lymphedema management techniques
Change in the number of times each patient performed the self-management program
Secondary outcome measures
Change in occupational performance
Change in quality of life

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: Health services research (discussion, interview)Experimental Treatment4 Interventions
Patients participate in a discussion with an occupational therapist via videoconferencing over 15 minutes QW for 4 weeks about their experience with lymphedema and the occupational services they received. After 4 weeks, some patients may also participate in an interview with an occupational therapist via videoconferencing over 60 minutes. During the first week of the study, patients also receive occupational therapy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing
2020
Completed Phase 3
~8850

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,441 Total Patients Enrolled
1 Trials studying Lymphedema
39 Patients Enrolled for Lymphedema
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,134 Total Patients Enrolled
31 Trials studying Lymphedema
14,311 Patients Enrolled for Lymphedema
Sherry HitePrincipal InvestigatorCity of Hope Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies which prospective participants can fill in this trial?

"Clinialtrials.gov indicates that the trial, which commenced on April 19th 2019 and was last updated on July 11th 2022 is not currently recruiting participants. Nonetheless, there are a multitude of other studies actively searching for patients at this time - 2331 to be exact."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
2019. "Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04465253.
~3 spots leftby Apr 2025
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