Head and Neck CancerNCT02204631
2 Phase Use Of Educational Materials In Head And Neck Cancer Center
A study testing Head and Neck Educational Handbook in people with Head and Neck Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future. 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?
- Head and Neck Educational Handbook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2014to 22 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
- Patients who have a treatment plan including both chemotherapy and radiation.
- Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
- Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.
Who cannot join
- Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
- Patients who cannot speak, read and write in English with minimal assistance from a family member.
- Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
- Patients who will not be receiving their cancer treatment at MGH.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center
The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.
Read the detailed description
There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.
- Conditions
- Head and Neck Cancer
- Being tested
- Head and Neck Educational Handbook
- Keywords
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and Neck Educational HandbookOther
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Educational Handbook | Experimental | * Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).
* After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth.
* Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception). Receives: Other: Head and Neck Educational Handbook |
| Non Head and Neck Educational Handbook | No intervention | * Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception). * The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center. * Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception). * At completion of "Phase I", all 30 participants will also be given a copy of the handbook and an accompanying questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information Satisfaction Questionnaire (ISQ)
The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.
Measured: Baseline, 4 Months, 6 Months
Secondary outcomes (3)
Percentage of participant change of scores of psychological distress
Measured: Baseline, 4 Months, 6 Months
Percentage of change participant symptom burden
Measured: Baseline, 4 Months, 6 Months
Percentage of Participant illness perception
Measured: Baseline, 4 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start12 Aug 2014
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
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 Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori J. Wirth, MD, Massachusetts General Hospital
- Investigators
- Lori Wirth, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204631
- Sponsor's protocol ID
- 14-244
- Status last verified
- May 2017
- First submitted
- 29 Jul 2014
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center
- ClinicalTrials.gov ID
- NCT02204631
- Acronym / sponsor ID
- 14-244
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 30 Jul 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.
The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.
Detailed description
There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Educational Handbook | Experimental | Other: Head and Neck Educational Handbook* Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception). * After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth. * Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception). |
| Non Head and Neck Educational Handbook | No intervention | –* Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception). * The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center. * Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception). * At completion of "Phase I", all 30 participants will also be given a copy of the handbook and an accompanying questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
- Patients who have a treatment plan including both chemotherapy and radiation.
- Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
- Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.
Key exclusion criteria (4 listed)
- Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
- Patients who cannot speak, read and write in English with minimal assistance from a family member.
- Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
- Patients who will not be receiving their cancer treatment at MGH.
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 |
|---|---|---|
| Head and Neck Educational Handbook | Other | Head and Neck Educational Handbook |
Primary outcome
Information Satisfaction Questionnaire (ISQ)
Time frame: Baseline, 4 Months, 6 Months
The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.
3 secondary outcomes
Percentage of participant change of scores of psychological distress
Time frame: Baseline, 4 Months, 6 Months
Percentage of change participant symptom burden
Time frame: Baseline, 4 Months, 6 Months
Percentage of Participant illness perception
Time frame: Baseline, 4 Months, 6 Months
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 25 May 2017.
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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.
Lori Wirth, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head and Neck Educational Handbook in people with Head and Neck Cancer, run by Massachusetts General Hospital 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 4 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 25 May 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?
Information Satisfaction Questionnaire (ISQ) (time frame: Baseline, 4 Months, 6 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 May 2017.