Back to resultsRemotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
Primary Purpose
Breast Carcinoma, Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Motivational Interviewing
Motivational Interviewing
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Carcinoma
Eligibility Criteria
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
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Health services research (discussion, interview)
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in daily performance of the lymphedema management techniques
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.
Change in arm girth measurement
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.
Change in the number of times each patient performed the self-management program
Will be compared by a paired t-test.
Secondary Outcome Measures
Change in quality of life
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.
Change in occupational performance
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.
Full Information
NCT ID
NCT04465253
First Posted
July 7, 2020
Last Updated
July 12, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04465253
Brief Title
Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
Official Title
The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This trial studies how well the Remotivation Process in an occupational therapy program works in improving adherence to lymphedema treatment programs in patients with breast cancer-related lymphedema. Lymphedema treatment programs are well developed and effective, but adherence to these programs are an issue. The Remotivation Process is a series of techniques that helps guide discussions between occupational therapists and their patients based on their level of motivation. This study uses the Remotivation Process by gathering patients' thoughts about their experience with lymphedema and occupational therapy services to determine their motivation and learn about the barriers they face in order to improve adherence to these programs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Lymphedema
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health services research (discussion, interview)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Undergo standard of care occupational therapy
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI, Motivational Interviewing Intervention
Intervention Description
Participate in discussions via videoconferencing
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI, Motivational Interviewing Intervention
Intervention Description
Participate in interview via videoconferencing
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in daily performance of the lymphedema management techniques
Description
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.
Time Frame
Baseline up to 4 weeks
Title
Change in arm girth measurement
Description
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.
Time Frame
Baseline up to 4 weeks
Title
Change in the number of times each patient performed the self-management program
Description
Will be compared by a paired t-test.
Time Frame
Baseline up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
Baseline up to 4 weeks
Title
Change in occupational performance
Description
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.
Time Frame
Baseline up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Hite
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
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