Head And Neck CancerNCT00824252
Spousal Support 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 look at social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head And Neck Cancer
- What is being tested?
- Questionnaires & Study Visit
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2008to 23 Feb 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and neck cancer patients who will be starting radiation therapy and their spouses.
Who may be able to join
- Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer
- Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less
- Part 2. Patient has a spouse or significant other with whom he/she resides
- Part 2. Patient is able to vocalize well enough to complete the spousal interaction task
- Parts 1 and 2. Patient and spouse are able to read and speak English
- Parts 1 and 2. Patient and spouse are able to provide informed consent
- Parts 1 and 2. Patient and spouse are at least 18 years of age
- Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient.
Who cannot join
- 1) None
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
Official title: Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer
The goal of this research study is to look at social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses.
Read the detailed description
If you agree to take part in this study, you first fill out a questionnaire, which will take about 1 hour. You will also have a study visit with your spouse, where you and your spouse will fill out several questionnaires, have a videotaped discussion, and complete tasks on the computer. This study visit will last about 75 minutes.
Health and Relationship Questionnaire:
On Day 1 you will be given a questionnaire about your health and your relationship with your spouse. This will be before you begin treatment. You may complete the questionnaire while waiting for your clinic appointment, or you may take it home, complete it, and return it by mail. It will take about 60 minutes to complete.
If you agree to take part in this study, your spouse will also be asked to take part. If your spouse does not wish to take part, your participation in this study will be over after you complete the questionnaire.
Study Visit:
During the first 2 weeks after you start treatment, you and your spouse will come to the clinic together for a study visit. The visit will take about 75 minutes. For all of the procedures at this visit, you and your spouse will be in the same room together. A study staff member will also be in the room, except for during the videotaped discussions. The following procedures will be performed at the study visit:
- You will complete a questionnaire that asks you to identify one instance where you felt supported by your spouse since the cancer diagnosis, and one issue that has caused conflict with your spouse since the cancer diagnosis. You will also complete a questionnaire about your mood. Your spouse will complete the same questionnaires. This will take about 10-15 minutes.
- You and your spouse will take part in a videotaped discussion. You will discuss the topic you identified as an instance where you felt supported by your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as an instance where he/she felt supported by you since the cancer diagnosis. This will take about 10-15 minutes.
- After the discussion, you and your spouse will be asked to complete a cognitive (thinking) task, on separate computers. Words in different colors will appear on the computer screen. The goal of the task is to name the color of the words, as quickly as possible. It will take about 5 minutes to complete the task.
- After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
- You and your spouse will take part in another videotaped discussion. This time, you will discuss the topic you identified as causing conflict with your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as causing conflict since the cancer diagnosis. It will take about 10-15 minutes.
- After the discussion, you and your spouse will repeat the same cognitive task. It will again be on separate computers and will take about 5 minutes.
- After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
- At the conclusion of the study visit, you will have the option to view the videotape of your discussion with your spouse. If, after viewing your videotape you decide for any reason that you do not want it to be used for research, the tape will be destroyed.
Follow-Up Questionnaire:
You will complete the Health and Relationship questionnaire 2 more times.
If possible, you will complete this questionnaire while you are at the clinic for your regularly scheduled follow-up visits that will occur 4 months and 12 months after you complete your radiation treatment. Otherwise, if your appointment is not on the same schedule as this study's questionnaire schedule, you will receive the questionnaire by mail and you should mail it back to the study staff.
Information Collection:
During the course of this study, a study staff member will review your medical records to collect medical information such as your diagnosis and health history.
Length of Study:
After you complete the last questionnaire (Month 12), your participation in this study will be over.
This is an investigational study. For any questionnaires that you are asked to return by mail, you will be provided stamped envelopes.
Up to 452 participants (226 patients and 226 spouses) will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Head And Neck Cancer
- Being tested
- Questionnaires & Study Visit
- Keywords
- Head And Neck Cancer, HNC, Radiation Therapy, Spousal Support, Emotional Disclosure, Observational, Social Constraints, Questionnaires, Videotaped Interview, Quality of Life
- 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.
Questionnaires & Study VisitBehavioural
Also called Survey
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
| Study group | Role | What they receive |
|---|---|---|
| Spousal Support | Questionnaire for Head and Neck Cancer Patients + Spouses Receives: Behavioral: Questionnaires & Study Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social + Relationship Factors Affecting QOL of HNC Patients & Spouses
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study start8 Dec 2008
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
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
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, PHD, MA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824252
- Sponsor's protocol ID
- 2008-0188
- Other IDs
- K07CA124668
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2009
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00824252
- Acronym / sponsor ID
- 2008-0188
- Conditions
- Head And Neck Cancer
- Keywords
- Head And Neck Cancer, HNC, Radiation Therapy, Spousal Support, Emotional Disclosure, Observational, Social Constraints, Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Dec 2008 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 16 Jan 2009 (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 look at social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses.
Detailed description
If you agree to take part in this study, you first fill out a questionnaire, which will take about 1 hour. You will also have a study visit with your spouse, where you and your spouse will fill out several questionnaires, have a videotaped discussion, and complete tasks on the computer. This study visit will last about 75 minutes.
Health and Relationship Questionnaire:
On Day 1 you will be given a questionnaire about your health and your relationship with your spouse. This will be before you begin treatment. You may complete the questionnaire while waiting for your clinic appointment, or you may take it home, complete it, and return it by mail. It will take about 60 minutes to complete.
If you agree to take part in this study, your spouse will also be asked to take part. If your spouse does not wish to take part, your participation in this study will be over after you complete the questionnaire.
Study Visit:
During the first 2 weeks after you start treatment, you and your spouse will come to the clinic together for a study visit. The visit will take about 75 minutes. For all of the procedures at this visit, you and your spouse will be in the same room together. A study staff member will also be in the room, except for during the videotaped discussions. The following procedures will be performed at the study visit:
- You will complete a questionnaire that asks you to identify one instance where you felt supported by your spouse since the cancer diagnosis, and one issue that has caused conflict with your spouse since the cancer diagnosis. You will also complete a questionnaire about your mood. Your spouse will complete the same questionnaires. This will take about 10-15 minutes.
- You and your spouse will take part in a videotaped discussion. You will discuss the topic you identified as an instance where you felt supported by your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as an instance where he/she felt supported by you since the cancer diagnosis. This will take about 10-15 minutes.
- After the discussion, you and your spouse will be asked to complete a cognitive (thinking) task, on separate computers. Words in different colors will appear on the computer screen. The goal of the task is to name the color of the words, as quickly as possible. It will take about 5 minutes to complete the task.
- After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
- You and your spouse will take part in another videotaped discussion. This time, you will discuss the topic you identified as causing conflict with your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as causing conflict since the cancer diagnosis. It will take about 10-15 minutes.
- After the discussion, you and your spouse will repeat the same cognitive task. It will again be on separate computers and will take about 5 minutes.
- After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
- At the conclusion of the study visit, you will have the option to view the videotape of your discussion with your spouse. If, after viewing your videotape you decide for any reason that you do not want it to be used for research, the tape will be destroyed.
Follow-Up Questionnaire:
You will complete the Health and Relationship questionnaire 2 more times.
If possible, you will complete this questionnaire while you are at the clinic for your regularly scheduled follow-up visits that will occur 4 months and 12 months after you complete your radiation treatment. Otherwise, if your appointment is not on the same schedule as this study's questionnaire schedule, you will receive the questionnaire by mail and you should mail it back to the study staff.
Information Collection:
During the course of this study, a study staff member will review your medical records to collect medical information such as your diagnosis and health history.
Length of Study:
After you complete the last questionnaire (Month 12), your participation in this study will be over.
This is an investigational study. For any questionnaires that you are asked to return by mail, you will be provided stamped envelopes.
Up to 452 participants (226 patients and 226 spouses) will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spousal Support | – | Behavioral: Questionnaires & Study VisitQuestionnaire for Head and Neck Cancer Patients + Spouses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer patients who will be starting radiation therapy and their spouses.
Key inclusion criteria (8 listed)
- Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer
- Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less
- Part 2. Patient has a spouse or significant other with whom he/she resides
- Part 2. Patient is able to vocalize well enough to complete the spousal interaction task
- Parts 1 and 2. Patient and spouse are able to read and speak English
Key exclusion criteria (1 listed)
- 1) None
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 |
|---|---|---|
| Questionnaires & Study VisitAlso: SurveyIndividual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours) | Behavioural | Spousal Support |
Primary outcome
Social + Relationship Factors Affecting QOL of HNC Patients & Spouses
Time frame: 12 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 8 Mar 2022.
- 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.
Kathrin Milbury, PHD, MA 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 8 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: finished, as of the sponsor's last update on 8 Mar 2022. 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?
Social + Relationship Factors Affecting QOL of HNC Patients & Spouses (time frame: 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 8 Mar 2022.