Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498875
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2007-07-06
Brief Title:
Depression and Adherence in Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Depression and Adherence in Head and Neck Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients Recruitment rate patient satisfaction attendance questionnaire completion rates and the reliability and validity of the questionnaires will be assessed
Conduct preliminary analyses on the efficacy of the intervention in improving patients depression Evaluate whether depression levels in patients receiving the intervention decreases and whether the decrease is greater among those who complete more sessions
Test the relationship between patients depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens
Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients Recruitment rate patient satisfaction attendance questionnaire completion rates and the reliability and validity of the questionnaires will be assessed
Conduct preliminary analyses on the efficacy of the intervention in improving patients depression Evaluate whether depression levels in patients receiving the intervention decreases and whether the decrease is greater among those who complete more sessions
Test the relationship between patients depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens
Detailed Description:
You will be asked to fill out a questionnaire containing questions about your mood coping with cancer how closely you follow your treatment schedule your thoughts your demographic information such as age and race and your medical history It should take between 25-35 minutes to complete the questionnaire If you score as nondepressed on the questionnaire you will be contacted again every week for 6 weeks during radiation treatment to check for depression again If you score as depressed during a later screening you will then be asked additional questions about your symptoms coping and social support It should take between 10-20 minutes to complete these additional questions
If the answers to your questionnaire indicate that you may be depressed you will be offered the intervention portion of the study Only those participants who score as depressed on the questionnaire will be assigned to the intervention You will then be informed of your test results and provided with a list of community referrals Whoever is responsible for your treatment whether he or she is a MD Anderson physician community referring physician or both will also be informed of these test results and a note will be added to your medical record
You will be asked to take part in 7 sessions with a trained doctoral-level psychologist or advanced clinical doctoral student under the supervision of a licensed psychiatrist The first two sessions may be conducted in person face to face or may be conducted over the telephone The remaining five sessions will be done over the telephone These sessions will last between 30 and 45 minutes and will occur every week for seven weeks
The 30-45 minute telephone sessions will use cognitive-behavioral techniques a method proven to be effective in relieving depressive symptoms Cognitive-behavioral techniques will teach you skills in relaxation and activity scheduling as well as ways to recognize and fight negative thoughts You will also be given a journal to record and practice ways of fighting depression The intervention will include an educational component for your spousepartner or caregiver on the nature of clinical depression The spousecaregiver will be given a booklet which explains facts about depressive disorders and helpful ways that they can support you You may also be given over-the counter samples of toothpaste and oral products if approved by your doctor or dentist You will also be given the use of a mini-food-blender to help you problem solve issues of eating during the course of the study You will be asked to return the mini-food-blender at the end of the study
If you participate in the intervention upon completion you will receive a short survey asking about your satisfaction with the intervention After completing the first questionnaire you may be contacted again to complete five follow-up questionnaires at the beginning of radiation treatment as well as six and twelve weeks and again six and twelve months after radiation treatment begins The questionnaires will be similar to the first one but will also contain questions about any additional depression care you received while participating in the study or after the intervention This information will include prescription of antidepressants formal referral to psychiatric services referral to support groups and any depression care you received in addition to the intervention in this study You will also be asked how closely you followed the swallowing exercises your dental care habits and your referrals to other sources in the community
Researchers will also collect medical information from your medical record such as cancer stage if the disease has gotten worse treatment and side effects This information will allow researchers to look at how specific treatments affect patients You may also be involved in an interview regarding your personal experience The study staff will tape-record the interview after you have given your consent verbally and on the tape In order to protect your confidentiality the study staff will store the digital record of the interview on an external hard drive and the record will be destroyed after the study is complete
To provide quality control for the intervention a random sample of telephone counseling sessions may be tape-recorded Before tape-recording the session the counselor will ask for your permission to be tape-recorded and will then tape-record your permission on the audiotape No identifying information will be recorded on the audiotape and the recorded sessions will be reviewed by project team members for research purposes only Audiotapes will be labeled with study identification numbers only so none of your personal information will be on the tape itself
If your answers to the questionnaires or your responses during the face-to-face sessions or telephone calls show that you are having suicidal thoughts or may need antidepressant medication you will be referred for a consultation with Dr Alan Valentine a MD Anderson psychiatrist who is also participating in this research study Researchers will also let your treating physicians know about the referral to Dr Valentine if you are referred for further treatment
If your answers to the questionnaires or your responses during the face to face sessions or telephone calls show that you have a problem with alcohol abuse you will be referred for a consultation with Dr Kathleen Rickman a MD Anderson advanced nurse practitioner who is also participating in this research study Researchers will also let your treating physicians know about the referral to Dr Rickman if you are referred for further treatment
This is an investigational study A total of 350 head and neck cancer patients will take part in this study All will be enrolled at MD Anderson
If the answers to your questionnaire indicate that you may be depressed you will be offered the intervention portion of the study Only those participants who score as depressed on the questionnaire will be assigned to the intervention You will then be informed of your test results and provided with a list of community referrals Whoever is responsible for your treatment whether he or she is a MD Anderson physician community referring physician or both will also be informed of these test results and a note will be added to your medical record
You will be asked to take part in 7 sessions with a trained doctoral-level psychologist or advanced clinical doctoral student under the supervision of a licensed psychiatrist The first two sessions may be conducted in person face to face or may be conducted over the telephone The remaining five sessions will be done over the telephone These sessions will last between 30 and 45 minutes and will occur every week for seven weeks
The 30-45 minute telephone sessions will use cognitive-behavioral techniques a method proven to be effective in relieving depressive symptoms Cognitive-behavioral techniques will teach you skills in relaxation and activity scheduling as well as ways to recognize and fight negative thoughts You will also be given a journal to record and practice ways of fighting depression The intervention will include an educational component for your spousepartner or caregiver on the nature of clinical depression The spousecaregiver will be given a booklet which explains facts about depressive disorders and helpful ways that they can support you You may also be given over-the counter samples of toothpaste and oral products if approved by your doctor or dentist You will also be given the use of a mini-food-blender to help you problem solve issues of eating during the course of the study You will be asked to return the mini-food-blender at the end of the study
If you participate in the intervention upon completion you will receive a short survey asking about your satisfaction with the intervention After completing the first questionnaire you may be contacted again to complete five follow-up questionnaires at the beginning of radiation treatment as well as six and twelve weeks and again six and twelve months after radiation treatment begins The questionnaires will be similar to the first one but will also contain questions about any additional depression care you received while participating in the study or after the intervention This information will include prescription of antidepressants formal referral to psychiatric services referral to support groups and any depression care you received in addition to the intervention in this study You will also be asked how closely you followed the swallowing exercises your dental care habits and your referrals to other sources in the community
Researchers will also collect medical information from your medical record such as cancer stage if the disease has gotten worse treatment and side effects This information will allow researchers to look at how specific treatments affect patients You may also be involved in an interview regarding your personal experience The study staff will tape-record the interview after you have given your consent verbally and on the tape In order to protect your confidentiality the study staff will store the digital record of the interview on an external hard drive and the record will be destroyed after the study is complete
To provide quality control for the intervention a random sample of telephone counseling sessions may be tape-recorded Before tape-recording the session the counselor will ask for your permission to be tape-recorded and will then tape-record your permission on the audiotape No identifying information will be recorded on the audiotape and the recorded sessions will be reviewed by project team members for research purposes only Audiotapes will be labeled with study identification numbers only so none of your personal information will be on the tape itself
If your answers to the questionnaires or your responses during the face-to-face sessions or telephone calls show that you are having suicidal thoughts or may need antidepressant medication you will be referred for a consultation with Dr Alan Valentine a MD Anderson psychiatrist who is also participating in this research study Researchers will also let your treating physicians know about the referral to Dr Valentine if you are referred for further treatment
If your answers to the questionnaires or your responses during the face to face sessions or telephone calls show that you have a problem with alcohol abuse you will be referred for a consultation with Dr Kathleen Rickman a MD Anderson advanced nurse practitioner who is also participating in this research study Researchers will also let your treating physicians know about the referral to Dr Rickman if you are referred for further treatment
This is an investigational study A total of 350 head and neck cancer patients will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02098 | REGISTRY | NCI CTRP | None |