- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465253
Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. How does remotivation process change daily performance of the lymphedema management techniques? (Quantitative Study) II. How does the Remotivation Process affect the client's manifestation of breast cancer-related lymphedema (BCRL)? (Quantitative Study) III. How does the Remotivation Process affect the client's occupational participation and quality of life? (Quantitative Study) IV. What are the perspectives of patients with BCRL about the self-management program after participating in an occupational therapy using the Remotivation Process? (Qualitative Study) V. What are the perspectives of patients with BCRL about their arm after the occupational therapy program? (Qualitative Study) VI. How do patients with BCRL describe their daily life after occupational therapy? (Qualitative Study)
OUTLINE:
Patients participate in a discussion with an occupational therapist via videoconferencing over 15 minutes once weekly (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.
After completion of study, patients are followed up at 1 month.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Unilateral upper extremity lymphedema following procedures to address breast cancer, able to communicate in English and participate in discussion sessions and follow up for the duration of the study of eight weeks
- Women will be able to participate in work, household responsibilities, and possible child-rearing responsibilities. These are necessary components of quality of life and occupation, which are the primary concepts of interest of the study. The study will include women with varied levels of functional performance status and life expectancy as long as they are willing to participate in a 15-minute discussion once a week in addition to their scheduled occupational therapy sessions at City of Hope (COH)
- The effects of Remotivation Process on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- The participant should also be receiving occupational therapy services at COH for BCRL during the first week of the study. The participant can be an on-going patient receiving customary occupational therapy services, or a new patient who will be seen for occupational therapy initial evaluation. The study will include patients with BCRL regardless of any other medical treatment they are receiving in addition to occupational therapy. Some participants may only need less than 4 weeks of customary occupational therapy in order to meet their intervention goals. In this case, the participant will still be asked to return at the end of the fourth week for follow up. Data obtained from the outcome measures will be included in quantitative analysis. The participant will also be included in the list of names that will be randomly selected for the 60-minute interview
Exclusion Criteria:
- Patients should not have any uncontrolled illness including ongoing or active infection such as cellulitis
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health services research (discussion, interview)
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.
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Ancillary studies
Other Names:
Ancillary studies
Undergo standard of care occupational therapy
Other Names:
Participate in discussions via videoconferencing
Other Names:
Participate in interview via videoconferencing
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in daily performance of the lymphedema management techniques
Time Frame: Baseline up to 4 weeks
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Will be assessed by frequency count that records the number of times the participant performed the self-management program during the first and fourth week of the study, which is a 7-day period.
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Baseline up to 4 weeks
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Change in arm girth measurement
Time Frame: Baseline up to 4 weeks
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Repeated measures analysis of variance will be used to establish significance and compare the pre-test and post-test girth of the affected arm as well as compare the difference between the affected and non-affected arm at pre-test and post-test.
Non-parametric tests will be used should the study not meet the assumptions of parametric test.
For non-parametric tests in this case, Friedman's analysis of variance will be used to compare girth.
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Baseline up to 4 weeks
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Change in the number of times each patient performed the self-management program
Time Frame: Baseline up to 4 weeks
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Will be compared by a paired t-test.
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Baseline up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: Baseline up to 4 weeks
|
Will be measured by the Lymphedema Quality of Life Inventory.
Will be compared using paired t-test.
Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory.
Non-parametric tests will be used should the study not meet the assumptions of parametric test.
For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores.
The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory.
The qualitative phase follows a descriptive phenomenological design.
Thematic analysis will be used to analyze data.
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Baseline up to 4 weeks
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Change in occupational performance
Time Frame: Baseline up to 4 weeks
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Will be measured by the Model of Human Occupation Screening Tool.
Will be compared using paired t-test.
Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory.
Non-parametric tests will be used should the study not meet the assumptions of parametric test.
For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores.
The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory.
The qualitative phase follows a descriptive phenomenological design.
Thematic analysis will be used to analyze data.
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Baseline up to 4 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sherry Hite, City of Hope Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18549 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2020-03475 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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