Breast CancerLymph-FlowNCT02462226
Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow)
A study testing The-Optimal-Lymph-Flow and Arm Precaution in people with Breast Cancer and Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume… Read more about this study
- Who is it for?
- Ages 21 to 89 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Lymphedema
- What is being tested?
- The-Optimal-Lymph-Flow and Arm Precaution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 1 Dec 2016
- 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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
- Patients who report persistent or intermittent pain, including aching, tenderness, soreness;
- Patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);
- Patients may or may not have a history of lymphedema or have been treated for lymphedema.
- Patients have Internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the Cancer Center.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who do not report any pain, including aching, tenderness, and soreness;
- Patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
- Patients who have lymphedema due to cancer recurrence.
- Patients with documented advanced cardiac or renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The-Optimal-Lymph-Flow ™: An e-Health Approach to Enhancing Management of Chronic Pain and Symptoms Related to Lymphedema Among Women Treated for Breast Cancer
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention.
Read the detailed description
Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, i.e. abnormal accumulation of lymph fluid in the ipsilateral upper limb or body.
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention. The study length for patients is 12 weeks.
- Conditions
- Breast Cancer, Pain, Lymphedema
- Being tested
- The-Optimal-Lymph-Flow, Arm Precaution
- Medical subject headings
- Breast Neoplasms, Pain, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The-Optimal-Lymph-FlowBehavioural
The-Optimal-Lymph-Flow ™ is a web-based educational and behavioral program focusing on self-care strategies to manage pain and symptoms related to lymphedema. The Optimal Lymph-Flow™ is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI.
Arm PrecautionBehavioural
The webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb.
| Study group | Role | What they receive |
|---|---|---|
| Arm Precaution | Active comparator | Patients assigned to Education #1 will receive arm precaution self-care strategies. The webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb. Exercises to promote limb mobility will also provided. Only the patients in the control group will be given access to Arm Precautions section.
Patients will be given access to the website to learn about the arm precaution program. Receives: Behavioral: Arm Precaution |
| The-Optimal-Lymph-Flow | Experimental | The Optimal Lymph-Flow™ is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI.
Patients will be given the access to the website to learn about the The-optimal-Lymph-Flow program Receives: Behavioral: The-Optimal-Lymph-Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI) is a valid and reliable self-report tool to assess pain, including aching, soreness, tenderness, as well as symptoms related to lymphedema (i.e. , arm swelling, breast swelling, chest wall swelling, heaviness, firmness, tightness, stiffness, burning, stabbing numbness, tenderness, stiffness, redness, blistering, and tingling (pins and needles. Each symptom can be treated as categorical variable by choosing a "Yes" or "No" to indicate the presence or absence of a given symptom. Each item can also be rated on a Likert-type scale from 0 (no presence of a given symptom) to 4 (greatest severity of a given symptom). Higher scores indicate more severe symptom presence. A response frame of last three months will be used for all participants to ensure the chronicity of symptom presence.
Measured: 12 weeks
Secondary outcomes (4)
Limb Volume Difference by Infra-red Perometer.
Perometry 350S will be performed on each arm as it is held horizontally. The perometer maps a 3-dimensional graph of the affected and non-affected extremities using numerous rectilinear light beams, and interfaces with a computer for data analysis and storage. A 3-dimensional limb image will be generated and limb volume will be calculated. This optoelectronic method has a standard deviation of 8.9 ml (arm), less than 0.5% of Limb Volume with repeated measuring.
Measured: 12 weeks
The Pain Impact Questionnaire™ (PIQ-6™)
The Pain Impact Questionnaire™ (PIQ-6™), a reliable and valid six question health survey, will be used to measure pain severity and the impact of pain on an individual's functional health and well-being. The PIQ-6 measures the severity of pain and its impact on work and leisure activities, as well as on emotional well-being within a variety of diseases and general populations. High PIQ-6™ T scores indicate greater pain impact/worse health
Measured: 12 Weeks
Body Weight and Body Mass Index [BMI]
An electrical device (InBody 520, Biospace Co., Ltd) will be used to measure the participants' body weight, BMI is calculated using the formula: weight (kg) / height (m2).
Measured: 12 Weeks
Risk Reduction Behavior Checklist
Risk Reduction Behavior Checklist is a structured self-report checklist that will be used to quantitatively and qualitatively assess patients' practice of self-care behaviors at the study endpoint of 12-week after intervention. The checklist include a list of self-care behaviors that promote lymph flow, e.g. muscle-tightening deep breathing, muscle-tightening pumping, shoulder exercises, large muscle exercises, and having nutrition-balance and portion-appropriate diet, as well as compression therapy for lymphedema.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462226
- Sponsor's protocol ID
- 15-00221
- Acronym
- Lymph-Flow
- Status last verified
- Apr 2017
- First submitted
- 20 May 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu MR, Axelrod D, Guth AA, Scagliola J, Rampertaap K, El-Shammaa N, Qiu JM, McTernan ML, Frye L, Park CS, Yu G, Tilley C, Wang Y. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial. JMIR Cancer. 2022 Jan 17;8(1):e29485. doi: 10.2196/29485.
PubMed 35037883Fu MR, Axelrod D, Guth A, Scagliola J, Rampertaap K, El-Shammaa N, Fletcher J, Zhang Y, Qiu JM, Schnabel F, Hiotis K, Wang Y, D'Eramo Melkus G. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol. JMIR Res Protoc. 2016 Jan 21;5(1):e7. doi: 10.2196/resprot.5104.
PubMed 26795447
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The-Optimal-Lymph-Flow ™: An e-Health Approach to Enhancing Management of Chronic Pain and Symptoms Related to Lymphedema Among Women Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT02462226
- Acronym / sponsor ID
- Lymph-Flow / 15-00221
- Conditions
- Breast Cancer, Pain, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention.
Detailed description
Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, i.e. abnormal accumulation of lymph fluid in the ipsilateral upper limb or body.
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention. The study length for patients is 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Precaution | Active comparator | Behavioral: Arm PrecautionPatients assigned to Education #1 will receive arm precaution self-care strategies. The webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb. Exercises to promote limb mobility will also provided. Only the patients in the control group will be given access to Arm Precautions section. Patients will be given access to the website to learn about the arm precaution program. |
| The-Optimal-Lymph-Flow | Experimental | Behavioral: The-Optimal-Lymph-FlowThe Optimal Lymph-Flow™ is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI. Patients will be given the access to the website to learn about the The-optimal-Lymph-Flow program |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
- Patients who report persistent or intermittent pain, including aching, tenderness, soreness;
- Patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);
- Patients may or may not have a history of lymphedema or have been treated for lymphedema.
- Patients have Internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the Cancer Center.
Key exclusion criteria (4 listed)
- Patients who do not report any pain, including aching, tenderness, and soreness;
- Patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
- Patients who have lymphedema due to cancer recurrence.
- Patients with documented advanced cardiac or renal disease.
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 |
|---|---|---|
| The-Optimal-Lymph-FlowThe-Optimal-Lymph-Flow ™ is a web-based educational and behavioral program focusing on self-care strategies to manage pain and symptoms related to lymphedema. The Optimal Lymph-Flow™ is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI. | Behavioural | The-Optimal-Lymph-Flow |
| Arm PrecautionThe webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb. | Behavioural | Arm Precaution |
Primary outcome
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI
Time frame: 12 weeks
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI) is a valid and reliable self-report tool to assess pain, including aching, soreness, tenderness, as well as symptoms related to lymphedema (i.e. , arm swelling, breast swelling, chest wall swelling, heaviness, firmness, tightness, stiffness, burning, stabbing numbness, tenderness, stiffness, redness, blistering, and tingling (pins and needles. Each symptom can be treated as categorical variable by choosing a "Yes" or "No" to indicate the presence or absence of a given symptom. Each item can also be rated on a Likert-type scale from 0 (no presence of a given symptom) to 4 (greatest severity of a given symptom). Higher scores indicate more severe symptom presence. A response frame of last three months will be used for all participants to ensure the chronicity of symptom presence.
4 secondary outcomes
Limb Volume Difference by Infra-red Perometer.
Time frame: 12 weeks
The Pain Impact Questionnaire™ (PIQ-6™)
Time frame: 12 Weeks
Body Weight and Body Mass Index [BMI]
Time frame: 12 Weeks
Risk Reduction Behavior Checklist
Time frame: 12 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 20 Apr 2017.
- Derived from this study: PubMed 35037883Fu MR, Axelrod D, Guth AA, Scagliola J, Rampertaap K, El-Shammaa N, Qiu JM, McTernan ML, Frye L, Park CS, Yu G, Tilley C, Wang Y. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial. JMIR Cancer. 2022 Jan 17;8(1):e29485. doi: 10.2196/29485.
- Derived from this study: PubMed 26795447Fu MR, Axelrod D, Guth A, Scagliola J, Rampertaap K, El-Shammaa N, Fletcher J, Zhang Y, Qiu JM, Schnabel F, Hiotis K, Wang Y, D'Eramo Melkus G. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol. JMIR Res Protoc. 2016 Jan 21;5(1):e7. doi: 10.2196/resprot.5104.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The-Optimal-Lymph-Flow and Arm Precaution in people with Breast Cancer and Pain, run by NYU Langone Health 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 6 inclusion and 4 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 20 Apr 2017. 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?
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462226, which also lists 2 linked publications.
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 20 Apr 2017.