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Telemedicine for Cancer-Related Depression and Pain
Phase 3
Waitlist Available
Research Sponsored by Indiana University Melvin and Bren Simon Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare telemedicine to standard care in treating patients with depression and/or pain caused by cancer.
Who is the study for?
This trial is for cancer patients experiencing moderate to severe depression (with a PHQ-9 score of 10 or higher) and/or pain (with a Brief Pain Inventory score of at least 6), not caused by treatments known for inducing depression. Participants must have a life expectancy over 6 months, speak English, and not be pregnant or suffering from cognitive impairments, schizophrenia, psychosis, or pursuing disability claims.Check my eligibility
What is being tested?
The study is examining the effectiveness of telemedicine versus standard care in managing depression and pain in cancer patients. It's designed as a phase III randomized clinical trial where participants are randomly assigned to receive either remote medical consultations (telemedicine) or traditional face-to-face healthcare services.See study design
What are the potential side effects?
Since this trial compares telemedicine with standard care rather than medication interventions, side effects are not typical as with drug trials. However, there may be differences in satisfaction or psychological impact between the two methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
Secondary outcome measures
Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
Health-related quality of life at baseline and 1, 3, 6, and 12 months
Treatment satisfaction at baseline and 1, 3, 6, and 12 months
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Who is running the clinical trial?
Indiana University Melvin and Bren Simon Cancer CenterLead Sponsor
5 Previous Clinical Trials
208 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,009 Total Patients Enrolled
97 Trials studying Pain
17,222 Patients Enrolled for Pain
Kurt Kroenke, MDStudy ChairRegenstrief Institute, Incorporated
5 Previous Clinical Trials
1,381 Total Patients Enrolled
4 Trials studying Pain
1,346 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My only pain comes from a condition I had before, like arthritis.My current pain is only because of a condition I already had, like arthritis.I am currently receiving hospice care.My depression is not caused by cancer treatments known to lead to depression.I experience pain due to my cancer.I feel persistently sad or have lost interest in activities.My depression was caused by cancer treatment.I have moderate memory or thinking problems.I have been diagnosed with clinical depression.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pain Patient Testimony for trial: Trial Name: NCT00313573 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this experimental program?
"Unfortunately, this study is not actively recruiting patients according to the clinicaltrials.gov website. The original posting was on February 1st, 2006 with the last update taking place on September 19th, 2013. There are, however, 1,729 other clinical trials that are currently looking for participants."
Answered by AI
What are the odds of experiencing adverse effects from this medication?
"The safety of this treatment was rated a 3 by our team at Power. This is due to the fact that this is a Phase 3 trial, thus there is both some efficacy data as well as multiple rounds of safety data."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Community Regional Cancer Care at Community Hospital North
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
Had depression to long. I thought it would be good to help with scientific research.
PatientReceived 1 prior treatment
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