Head and Neck CancerNCT00761397
Adherence to Swallowing Exercises in Head and Neck Cancer
An observational study of Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Interview, Phone Call and Brochure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2008to 30 Sep 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck cancer who previously had radiation treatment
Who may be able to join
- Men and women are eligible if they a) are predispositioned to receive radiation treatment for oropharyngeal, laryngeal, hypopharyngeal, nasopharyngeal, or an unknown primary cancer with cervical metastases,
- are stage II-IVB for oropharyngeal and laryngeal
- are stage I-IVB for hypopharyngeal and nasopharyngeal
- at least 18 years of age,
- speak English,
- are oriented to time, person, and place,
- and have a Zubrod performance status of 0 to 2.
Who cannot join
- have other cancer diagnoses, except non-melanoma skin cancer,
- had treatment for previous H \& N cancer or radiation to the head and neck, or
- history of previous head and neck surgery (excluding biopsy, tonsillectomy, tracheotomy or selective neck dissection),
- history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment.
Read the detailed description
If you agree to take part in this study, you will be taught ways to cope with the side effects of radiation as a way to help you do your swallowing exercises during radiation treatment. To find out if the swallowing exercises are being performed, researchers will compare 2 groups of participants.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups, the Study Program Group or the Usual Care Group. You will have an equal chance of being in either group.
As a part of standard of care, a speech pathologist will teach you how to perform swallowing exercises.
If you are assigned to the Study Program Group, you will complete the following:
- You will meet 1 time a week with study staff during radiation treatment either by phone or in person. These meetings will last between 15 to 30 minutes. During the meetings, you will be asked how many swallowing exercises you have completed during the last week and about any problems you may have had completing the exercises.
- You will receive phone calls for 4 weeks after the last radiation treatment. These phone calls will also last between 15 and 30 minutes. The study staff will ask questions about if you have been doing your exercises and discuss tips to help you continue to do them.
- You will receive a weekly newsletter that has information about ways to cope with any problems you may experience when completing the swallowing exercises.
If you are assigned to the Usual Care Group, you will complete the following:
- The study staff will follow up with you before and during your radiation treatments to make sure that you are scheduled with and have attended your speech pathology appointments. At these appointments, you will be taught how to do the swallowing exercises and given information to help you complete the exercises.
- You will receive a detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises.
- You will be asked if you would like to participate in another study protocol.
Questionnaires:
Participants in both groups will fill out a questionnaire asking questions about whether or not you have been completing the swallowing and dental exercises and how you have been coping with stress. The questionnaire will also collect information about the disease and demographic information such as age, gender, race, education level, and marital status. This questionnaire will take about 30 minutes to complete each time. You will complete this questionnaire on Day 1, and again 6 weeks, 6 months, 1 year, and 2 years after completing radiation treatment. The second and third questionnaires will be mailed to you along with a stamped envelope for you to return the questionnaires.
Interview:
You will be interviewed. The interview will ask questions about your successful strategies for coping with radiation side effects.
If you disclose through your assessments or discussion that you are having suicidal thoughts or could benefit from antidepressant medication, you may be referred for a consultation with Dr. Alan Valentine, an M. D. Anderson psychiatrist participating in this research study. Study staff will also let your treating doctor and/or regular doctor know about the referral for consultation.
Newsletter:
You will allow the research staff to record any successful strategies for coping with radiation side effects in a written newsletter that will be given to future participants.
Length of Study:
You will remain on study for up to 2 years.
This is an investigational study.
Up to 350 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Interview, Phone Call, Brochure, Questionnaire
- Keywords
- Oropharyngeal cancer, Dysphagic, Swallowing exercises, Swallowing rehabilitative regimens, PREPARE, Patients' Radiation Expectations, Prevention, Adherence, Rehabilitative Exercises
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises
Phone CallBehavioural
Phone call follow ups for 4 weeks after last radiation treatment
BrochureOther
Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises
QuestionnaireOther
Day 1 of study, 10 weeks after starting study, \& 12 months after starting study
| Study group | Role | What they receive |
|---|---|---|
| Study Program Group | Not described Receives: Behavioral: Interview; Behavioral: Phone Call; Other: Questionnaire | |
| Usual Care Group | Not described Receives: Other: Brochure; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)
Measured: Day 1, 10 Weeks, and at 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study start29 Aug 2008
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
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.
- More trials run by M.D. Anderson Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Eileen H. Shinn, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761397
- Sponsor's protocol ID
- 2008-0360
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2008
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Swallowing Exercises in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00761397
- Acronym / sponsor ID
- 2008-0360
- Conditions
- Head and Neck Cancer
- Keywords
- Oropharyngeal cancer, Dysphagic, Swallowing exercises, Swallowing rehabilitative regimens, PREPARE, Patients' Radiation Expectations, Prevention, Adherence, Rehabilitative Exercises
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 485 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 29 Aug 2008 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 29 Sep 2008 (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 goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment.
Detailed description
If you agree to take part in this study, you will be taught ways to cope with the side effects of radiation as a way to help you do your swallowing exercises during radiation treatment. To find out if the swallowing exercises are being performed, researchers will compare 2 groups of participants.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups, the Study Program Group or the Usual Care Group. You will have an equal chance of being in either group.
As a part of standard of care, a speech pathologist will teach you how to perform swallowing exercises.
If you are assigned to the Study Program Group, you will complete the following:
- You will meet 1 time a week with study staff during radiation treatment either by phone or in person. These meetings will last between 15 to 30 minutes. During the meetings, you will be asked how many swallowing exercises you have completed during the last week and about any problems you may have had completing the exercises.
- You will receive phone calls for 4 weeks after the last radiation treatment. These phone calls will also last between 15 and 30 minutes. The study staff will ask questions about if you have been doing your exercises and discuss tips to help you continue to do them.
- You will receive a weekly newsletter that has information about ways to cope with any problems you may experience when completing the swallowing exercises.
If you are assigned to the Usual Care Group, you will complete the following:
- The study staff will follow up with you before and during your radiation treatments to make sure that you are scheduled with and have attended your speech pathology appointments. At these appointments, you will be taught how to do the swallowing exercises and given information to help you complete the exercises.
- You will receive a detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises.
- You will be asked if you would like to participate in another study protocol.
Questionnaires:
Participants in both groups will fill out a questionnaire asking questions about whether or not you have been completing the swallowing and dental exercises and how you have been coping with stress. The questionnaire will also collect information about the disease and demographic information such as age, gender, race, education level, and marital status. This questionnaire will take about 30 minutes to complete each time. You will complete this questionnaire on Day 1, and again 6 weeks, 6 months, 1 year, and 2 years after completing radiation treatment. The second and third questionnaires will be mailed to you along with a stamped envelope for you to return the questionnaires.
Interview:
You will be interviewed. The interview will ask questions about your successful strategies for coping with radiation side effects.
If you disclose through your assessments or discussion that you are having suicidal thoughts or could benefit from antidepressant medication, you may be referred for a consultation with Dr. Alan Valentine, an M. D. Anderson psychiatrist participating in this research study. Study staff will also let your treating doctor and/or regular doctor know about the referral for consultation.
Newsletter:
You will allow the research staff to record any successful strategies for coping with radiation side effects in a written newsletter that will be given to future participants.
Length of Study:
You will remain on study for up to 2 years.
This is an investigational study.
Up to 350 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Program Group | – | Behavioral: Interview, Behavioral: Phone Call, Other: Questionnaire |
| Usual Care Group | – | Other: Brochure, Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck cancer who previously had radiation treatment
Key inclusion criteria (7 listed)
- Men and women are eligible if they a) are predispositioned to receive radiation treatment for oropharyngeal, laryngeal, hypopharyngeal, nasopharyngeal, or an unknown primary cancer with cervical metastases,
- are stage II-IVB for oropharyngeal and laryngeal
- are stage I-IVB for hypopharyngeal and nasopharyngeal
- at least 18 years of age,
- speak English,
Key exclusion criteria (4 listed)
- have other cancer diagnoses, except non-melanoma skin cancer,
- had treatment for previous H \& N cancer or radiation to the head and neck, or
- history of previous head and neck surgery (excluding biopsy, tonsillectomy, tracheotomy or selective neck dissection),
- history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
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 |
|---|---|---|
| Interview15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises | Behavioural | Study Program Group |
| Phone CallPhone call follow ups for 4 weeks after last radiation treatment | Behavioural | Study Program Group |
| BrochureDetailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises | Other | Usual Care Group |
| QuestionnaireDay 1 of study, 10 weeks after starting study, \& 12 months after starting study | Other | Study Program Group, Usual Care Group |
Primary outcome
Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)
Time frame: Day 1, 10 Weeks, and at 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Eileen H. Shinn, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by M.D. Anderson 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 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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?
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?
Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises) (time frame: Day 1, 10 Weeks, and at 12 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 13 Jan 2020.