Breast CarcinomaNCT04465253
Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema
A study testing Best Practice, Motivational Interviewing and Quality-of-Life Assessment in people with Breast Carcinoma and Lymphedema, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Lymphedema
- What is being tested?
- Best Practice, Motivational Interviewing and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma, Lymphedema
- Being tested
- Best Practice, Motivational Interviewing, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care occupational therapy
Motivational InterviewingBehavioural
Also called MI, Motivational Interviewing Intervention
Participate in discussions via videoconferencing
Motivational InterviewingBehavioural
Also called MI, Motivational Interviewing Intervention
Participate in interview via videoconferencing
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health services research (discussion, interview) | Experimental | 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. Receives: Other: Best Practice; Behavioral: Motivational Interviewing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 4 weeks
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.
Measured: Baseline up to 4 weeks
Change in the number of times each patient performed the self-management program
Will be compared by a paired t-test.
Measured: Baseline up to 4 weeks
Secondary outcomes (2)
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.
Measured: Baseline up to 4 weeks
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.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start13 May 2019
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sherry Hite, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465253
- Sponsor's protocol ID
- 18549
- Other IDs
- NCI-2020-03475, 18549, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04465253
- Acronym / sponsor ID
- 18549
- Conditions
- Breast Carcinoma, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (discussion, interview) | Experimental | Other: Best Practice, Behavioral: Motivational Interviewing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard of care occupational therapy | Other | Health services research (discussion, interview) |
| Motivational InterviewingAlso: MI, Motivational Interviewing InterventionParticipate in discussions via videoconferencing | Behavioural | Health services research (discussion, interview) |
| Motivational InterviewingAlso: MI, Motivational Interviewing InterventionParticipate in interview via videoconferencing | Behavioural | Health services research (discussion, interview) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health services research (discussion, interview) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (discussion, interview) |
Primary outcome
Change in daily performance of the lymphedema management techniques
Time frame: Baseline up to 4 weeks
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
Time frame: Baseline up to 4 weeks
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
Time frame: Baseline up to 4 weeks
Will be compared by a paired t-test.
2 secondary outcomes
Change in quality of life
Time frame: Baseline up to 4 weeks
Change in occupational performance
Time frame: Baseline up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Hite principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Motivational Interviewing and Quality-of-Life Assessment in people with Breast Carcinoma and Lymphedema, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily performance of the lymphedema management techniques (time frame: Baseline up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.