Head and Neck CancerNCT02170272
Home-Based Lymphedema Care Program (HBLCP) in Improving Lymphedema Self-Care in Head and Neck Cancer Survivors
A study testing Home-based Lymphedema Care Program in people with Head and Neck Cancer and Lymphedema, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Lymphedema
- What is being tested?
- Home-based Lymphedema Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- STAGE 1:
- EXPERT PANEL:
- A convenience sample of 10-15 experts (at least three lymphedema therapists and a varying number of HNC medical, radiation, and surgical oncologists, HNC nurse practitioners, speech and language pathologists, and nursing and informatics scientists) will be recruited to inform development of videos, protocol, and educational manual
- Knowledgeable in either HNC or lymphedema management or informatics
- LYMPHEDEMA THERAPISTS:
- Subsequent to the development of the materials, five additional therapists will be recruited to conduct an unbiased test of the therapists' training video and protocol
Show all 18Show fewer
- Certified lymphedema therapists
- Knowledgeable in head and neck lymphedema management
- PATIENT PARTICIPANTS:
- A convenience sample of 10 HNC survivors will be recruited to undergo a training session with the study therapist and test the patient video and educational manual
- Post HNC primary treatment
- No evidence of cancer (NED)
- Completion of lymphedema therapy for lymphedema of the head and neck
- Ability to understand English in order to complete questionnaires
- Able to complete the onsite training and home self-care activities for lymphedema management
- Able to provide informed consent
- STAGE 2 PATIENT PARTICIPANTS:
- Using the same inclusion criteria as Stage 1 a convenience sample of 30 different HNC survivors will be recruited
Who cannot join
- Patients with medical conditions (e.g., acute infection, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension) that would prohibit the safe implementation of home-based self-care of lymphedema will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema
This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop a home-based lymphedema care program (HBLCP) focusing on self-care of head and neck lymphedema in head and neck cancer (HNC) patients who have received lymphedema therapy. (Stage 1) II. To assess feasibility of the HBLCP for HNC patients with lymphedema to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) evaluate implementation fidelity (i.e., competence and compliance) and barriers to implementation fidelity; 3) assess safety; and 4) evaluate satisfaction. (Stage 2) III. To obtain preliminary efficacy data of the HBLCP via the following indicators: 1) head and neck lymphedema; 2) symptom burden; and 3) functional status. (Stage 2)
OUTLINE:
INTERVENTION DEVELOPMENT: A team of experts complete the development of a patient self-care video, an educational manual, a therapist training video, and a protocol. Lymphedema therapists test the therapist training video and protocol. Patients then undergo a training session with the study therapy and test the patient video and educational manual.
PILOT HBLCP TESTING: Participants undergo one training session with a lymphedema therapist. Participants also receive a self-care video and educational manual to review at home.
After completion of training session, participants are followed up at 1, 2, and 3 months.
- Conditions
- Head and Neck Cancer, Lymphedema
- Being tested
- Home-based Lymphedema Care Program
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Lymphedema Care ProgramBehavioural
Also called intervention, educational
Undergo HBLCP
| Study group | Role | What they receive |
|---|---|---|
| Home-based Lymphedema Care Program | Experimental | Home-based Lymphedema Care Program (HBLCP): Participants will undergo one training session with a lymphedema therapist, and then receive a self-care video and educational manual to review at home. After completion of training session, follow-up measures occur at 1, 2, and 3 months. Receives: Behavioral: Home-based Lymphedema Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity rate of head and neck lymphedema
Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased lymphedema severity) through measures of CTCAE, External HNLE-Fibrosis Grading Criteria, and Foldi's Scale at the study follow-ups
Measured: Baseline to up to 3 months
Secondary outcomes (2)
Change in rating of severity symptom burden
Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased symptom burden) through measures of VHNSS and LSIDS-H\&N at the study follow-ups
Measured: Baseline to up to 3 months
Change in rating of jaw, neck, and shoulder range of motion
Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved functional outcome measures in jaw, neck, and shoulder range of motion at the study follow-ups
Measured: Baseline to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionOct 2017
Why it stopped: Unable to obtain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vanderbilt Office of Clinical and Translational Scientist Development
- Responsible party
- Principal investigator, Jie Deng, Vanderbilt-Ingram Cancer Center
- Investigators
- Jie Deng, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170272
- Sponsor's protocol ID
- VICC HN 1431
- Other IDs
- NCI-2014-00867, P30CA068485
- Status last verified
- Jan 2018
- First submitted
- 13 Jun 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema
- ClinicalTrials.gov ID
- NCT02170272
- Acronym / sponsor ID
- VICC HN 1431
- Conditions
- Head and Neck Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to obtain funding
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vanderbilt Office of Clinical and Translational Scientist Development
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Jun 2014 (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.
This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life.
Detailed description
PRIMARY OBJECTIVES:
- To develop a home-based lymphedema care program (HBLCP) focusing on self-care of head and neck lymphedema in head and neck cancer (HNC) patients who have received lymphedema therapy. (Stage 1) II. To assess feasibility of the HBLCP for HNC patients with lymphedema to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) evaluate implementation fidelity (i.e., competence and compliance) and barriers to implementation fidelity; 3) assess safety; and 4) evaluate satisfaction. (Stage 2) III. To obtain preliminary efficacy data of the HBLCP via the following indicators: 1) head and neck lymphedema; 2) symptom burden; and 3) functional status. (Stage 2)
OUTLINE:
INTERVENTION DEVELOPMENT: A team of experts complete the development of a patient self-care video, an educational manual, a therapist training video, and a protocol. Lymphedema therapists test the therapist training video and protocol. Patients then undergo a training session with the study therapy and test the patient video and educational manual.
PILOT HBLCP TESTING: Participants undergo one training session with a lymphedema therapist. Participants also receive a self-care video and educational manual to review at home.
After completion of training session, participants are followed up at 1, 2, and 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based Lymphedema Care Program | Experimental | Behavioral: Home-based Lymphedema Care ProgramHome-based Lymphedema Care Program (HBLCP): Participants will undergo one training session with a lymphedema therapist, and then receive a self-care video and educational manual to review at home. After completion of training session, follow-up measures occur at 1, 2, and 3 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- STAGE 1:
- EXPERT PANEL:
- A convenience sample of 10-15 experts (at least three lymphedema therapists and a varying number of HNC medical, radiation, and surgical oncologists, HNC nurse practitioners, speech and language pathologists, and nursing and informatics scientists) will be recruited to inform development of videos, protocol, and educational manual
- Knowledgeable in either HNC or lymphedema management or informatics
- LYMPHEDEMA THERAPISTS:
Key exclusion criteria (1 listed)
- Patients with medical conditions (e.g., acute infection, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension) that would prohibit the safe implementation of home-based self-care of lymphedema will be excluded
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 |
|---|---|---|
| Home-based Lymphedema Care ProgramAlso: intervention, educationalUndergo HBLCP | Behavioural | Home-based Lymphedema Care Program |
Primary outcome
Change in severity rate of head and neck lymphedema
Time frame: Baseline to up to 3 months
Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased lymphedema severity) through measures of CTCAE, External HNLE-Fibrosis Grading Criteria, and Foldi's Scale at the study follow-ups
2 secondary outcomes
Change in rating of severity symptom burden
Time frame: Baseline to up to 3 months
Change in rating of jaw, neck, and shoulder range of motion
Time frame: Baseline to up to 3 months
Results and safety
The study was stopped early (reason given: Unable to obtain funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Jie Deng principal investigator
Vanderbilt-Ingram Cancer 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 Home-based Lymphedema Care Program in people with Head and Neck Cancer and Lymphedema, run by Vanderbilt-Ingram Cancer 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 18 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Jan 2018. 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 was stopped early (reason given: Unable to obtain funding). Results are not available in the source record.
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 severity rate of head and neck lymphedema (time frame: Baseline to up to 3 months). 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 25 Jan 2018.