CancerNCT00863200
Identification and Treatment of Depression
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Telephone Intervention and Questionnaires & Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 12 Feb 2019
- 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: African American or Hispanics over 18 years of age being treated for cancer at LBJ General Hospital in Houston.
Who may be able to join
- Diagnosis of cancer
- Self-identified as African American or Latino
- English or Spanish speaking
- 18 years of age or older
- Receiving treatment in the medical oncology, genitourinary oncology, or gynecologic oncology clinics at LBJ General Hospital
- Reports a level of "4" or greater on the MDASI "sadness" and/or "distress" items.
Who cannot join
- 1) Not willing to use a telephone to report symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Treatment of Depression in Underserved African American and Latino Patients With Cancer
The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: telephone intervention or standard care. You have an equal chance of being assigned to either group.
No matter which group you are assigned to, you will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing during your regularly scheduled visits. You will also be asked to call your doctor and/or nurse right away when your symptoms are severe. The doctor and/or nurse will give you instructions about calling when your symptoms are severe.
You will receive educational material about emotional distress, sadness, and depression in people who are being treated for cancer. The material also will tell you about community resources that are available for people with cancer.
Feedback Group:
If you are assigned to the feedback group, your symptom information will be collected using a telephone system. You will be asked to rate 13 symptoms, such as sadness, emotional distress, and fatigue, on a scale of 0 to 10 using the touch tone key pad of your telephone. The 0 means that you are not having the symptom at all, and the 10 means that the symptom is as bad as you can imagine.
If you rate either of the 2 symptoms of sadness and/or emotional distress as moderate or severe, then the telephone system will send a message to the research staff and your doctor or nurse right away. Only the symptoms of sadness and emotional distress will be reported right away to the doctor or nurse and the research staff. If you answer moderate to severe to any other questions, it will not be sent right away to the doctor, nurse or study staff. The telephone system usually works very well. But, if for any reason the telephone system is not working, the research staff will report any moderate or severe sadness or distress to your doctor or nurse. Your doctor or nurse also will receive a written summary of your symptom ratings before your next clinic visit.
Standard Care Group:
If you are assigned to the standard care group, your symptom information will not be collected using the telephone system. You will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing.
Telephone System:
For patients in the feedback group, the research staff will teach you how to use a telephone system for measuring your symptoms. The research staff also will ask you to practice using the telephone system. The telephone system will call you 1 time a week for 16 weeks. You will be asked to rate your symptoms and how much the symptoms interfere with your life. You can set up a time to receive the phone calls that works best for you. Rating your symptoms using the telephone system will take about 5 minutes for each call.
If you do not answer the telephone system on the first call, then the system will try to reach you 3 more times. If you do not answer after the fourth try, then the research staff will call you to find out why you could not answer the telephone system. If you prefer, the research staff will change the day or time that the telephone system calls you.
Questionnaires and Interviews:
You will be asked to fill out 3 questionnaires during 3 regularly scheduled clinic visits. These questionnaires ask questions about pain, stress, sadness, quality of life, and other symptoms you may be experiencing. You will also compete an interview at the first and third visit. During the interview, you will be asked questions about your feelings and emotions. The questionnaires and interview will be completed at the following times:
- At the first visit when you enroll in the study, 8-10 weeks after the study begins, and 14-16 weeks after the study begins, you will complete the questionnaires. This will take about 45 minutes.
- At the first visit and 14-16 weeks after the study begins, you will complete a short interview. Completing the interview will take about 15 minutes.
Length of Study:
Your participation in this study will last up to 16 weeks.
This is an investigational study.
Up to 166 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Cancer
- Being tested
- Telephone Intervention, Questionnaires & Interviews
- Keywords
- Depression, Cancer, African Americans, Latinos, Hispanics, Interactive voice response, IVR, Behavioral Intervention
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterventionBehavioural
Also called Interactive voice response, IVR
Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.
Questionnaires & InterviewsBehavioural
Also called Survey
3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Intervention Group | Not described Receives: Behavioral: Telephone Intervention; Behavioral: Questionnaires & Interviews | |
| Standard Care Group | Not described Receives: Behavioral: Questionnaires & Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Tito Mendoza, BS,MED,MS,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863200
- Sponsor's protocol ID
- 2008-0327
- Status last verified
- May 2019
- First submitted
- 16 Mar 2009
- Last updated
- 28 May 2019
- 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 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Treatment of Depression in Underserved African American and Latino Patients With Cancer
- ClinicalTrials.gov ID
- NCT00863200
- Acronym / sponsor ID
- 2008-0327
- Conditions
- Cancer
- Keywords
- Depression, Cancer, African Americans, Latinos, Hispanics, Interactive voice response, IVR, Behavioral Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Mar 2009 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 17 Mar 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 learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.
Detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: telephone intervention or standard care. You have an equal chance of being assigned to either group.
No matter which group you are assigned to, you will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing during your regularly scheduled visits. You will also be asked to call your doctor and/or nurse right away when your symptoms are severe. The doctor and/or nurse will give you instructions about calling when your symptoms are severe.
You will receive educational material about emotional distress, sadness, and depression in people who are being treated for cancer. The material also will tell you about community resources that are available for people with cancer.
Feedback Group:
If you are assigned to the feedback group, your symptom information will be collected using a telephone system. You will be asked to rate 13 symptoms, such as sadness, emotional distress, and fatigue, on a scale of 0 to 10 using the touch tone key pad of your telephone. The 0 means that you are not having the symptom at all, and the 10 means that the symptom is as bad as you can imagine.
If you rate either of the 2 symptoms of sadness and/or emotional distress as moderate or severe, then the telephone system will send a message to the research staff and your doctor or nurse right away. Only the symptoms of sadness and emotional distress will be reported right away to the doctor or nurse and the research staff. If you answer moderate to severe to any other questions, it will not be sent right away to the doctor, nurse or study staff. The telephone system usually works very well. But, if for any reason the telephone system is not working, the research staff will report any moderate or severe sadness or distress to your doctor or nurse. Your doctor or nurse also will receive a written summary of your symptom ratings before your next clinic visit.
Standard Care Group:
If you are assigned to the standard care group, your symptom information will not be collected using the telephone system. You will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing.
Telephone System:
For patients in the feedback group, the research staff will teach you how to use a telephone system for measuring your symptoms. The research staff also will ask you to practice using the telephone system. The telephone system will call you 1 time a week for 16 weeks. You will be asked to rate your symptoms and how much the symptoms interfere with your life. You can set up a time to receive the phone calls that works best for you. Rating your symptoms using the telephone system will take about 5 minutes for each call.
If you do not answer the telephone system on the first call, then the system will try to reach you 3 more times. If you do not answer after the fourth try, then the research staff will call you to find out why you could not answer the telephone system. If you prefer, the research staff will change the day or time that the telephone system calls you.
Questionnaires and Interviews:
You will be asked to fill out 3 questionnaires during 3 regularly scheduled clinic visits. These questionnaires ask questions about pain, stress, sadness, quality of life, and other symptoms you may be experiencing. You will also compete an interview at the first and third visit. During the interview, you will be asked questions about your feelings and emotions. The questionnaires and interview will be completed at the following times:
- At the first visit when you enroll in the study, 8-10 weeks after the study begins, and 14-16 weeks after the study begins, you will complete the questionnaires. This will take about 45 minutes.
- At the first visit and 14-16 weeks after the study begins, you will complete a short interview. Completing the interview will take about 15 minutes.
Length of Study:
Your participation in this study will last up to 16 weeks.
This is an investigational study.
Up to 166 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Intervention Group | – | Behavioral: Telephone Intervention, Behavioral: Questionnaires & Interviews |
| Standard Care Group | – | Behavioral: Questionnaires & Interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African American or Hispanics over 18 years of age being treated for cancer at LBJ General Hospital in Houston.
Key inclusion criteria (6 listed)
- Diagnosis of cancer
- Self-identified as African American or Latino
- English or Spanish speaking
- 18 years of age or older
- Receiving treatment in the medical oncology, genitourinary oncology, or gynecologic oncology clinics at LBJ General Hospital
Key exclusion criteria (1 listed)
- 1) Not willing to use a telephone to report symptoms.
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 |
|---|---|---|
| Telephone InterventionAlso: Interactive voice response, IVRSymptom information will be collected using an automated telephone system, approximately 5 minutes per week. | Behavioural | Telephone Intervention Group |
| Questionnaires & InterviewsAlso: Survey3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits. | Behavioural | Standard Care Group, Telephone Intervention Group |
Primary outcome
Learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.
Time frame: 3 Years
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 28 May 2019.
- 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.
Tito Mendoza, BS,MED,MS,PHD 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 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 6 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 28 May 2019. 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?
Learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer. (time frame: 3 Years). 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 28 May 2019.