Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema

Lymphedema Clinical Trial

Official title:

The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465253
• Other study ID #: 18549
• Secondary ID: NCI-2020-0347518
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: June 21, 2022

Study information

• Verified date: July 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Carcinoma
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Best Practice
Undergo standard of care occupational therapy

Behavioral:
• Motivational Interviewing
Participate in discussions via videoconferencing
• Motivational Interviewing
Participate in interview via videoconferencing

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 4 weeks
Primary	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.	Baseline up to 4 weeks
Primary	Change in the number of times each patient performed the self-management program	Will be compared by a paired t-test.	Baseline up to 4 weeks
Secondary	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.	Baseline up to 4 weeks
Secondary	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.	Baseline up to 4 weeks