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Internet-Based Pain Management Program for Cancer Survivors (IMPACTS Trial)
N/A
Recruiting
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
Age ≥18 years at the time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10, 22, and 24 week
Awards & highlights
IMPACTS Trial Summary
This trial is testing whether an online pain coping skills program, plus enhanced usual care, can help improve cancer survivors' pain severity and pain interference more than just enhanced usual care alone.
Who is the study for?
This trial is for adult cancer survivors with persistent pain, who've been treated with surgery, radiation, or chemotherapy. They must have stable cancer and not be planning major treatment changes during the study. Participants need reliable internet access and should understand English. Those on a steady pain medication regimen can join but shouldn't plan to increase their dosage.Check my eligibility
What is being tested?
The study tests an Internet-based program designed to help manage pain against usual care alone in cancer survivors. It measures how well the program reduces pain severity and interference using the Brief Pain Inventory before and after the intervention.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on coping skills for managing pain via an online platform, there are no direct side effects like those associated with medications or surgical procedures.
IMPACTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had only superficial skin cancers or in situ malignancy.
Select...
I am 18 years old or older.
Select...
I have been treated for cancer with surgery, radiation, or drugs.
Select...
It has been 5 years or less since I finished my cancer treatment.
Select...
I have been treated for invasive cancer, not just skin cancer or in situ malignancy.
Select...
I am not planning to change my current cancer treatment for the next three months.
Select...
My pain level is 4 or higher on the PROMIS scale.
Select...
I can take care of myself and am up and about more than half of my waking hours.
IMPACTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 10, 22, and 24 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10, 22, and 24 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Health-Related Quality of Life
Opioid/analgesic medication use
Pain Interference
+2 moreIMPACTS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Internet-based program + Pain EducationExperimental Treatment1 Intervention
If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
Group II: Pain Education OnlyActive Control1 Intervention
If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,003,781 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,192 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
648,908 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over two weeks since my last minor surgery.I have never had only superficial skin cancers or in situ malignancy.I have been on the same cancer treatment for at least 4 weeks.My only pain conditions are not related to my cancer (like arthritis or migraines).I am not on hospice or end-of-life care but may receive symptom management with my treatment.I am either not on any cancer treatment or on a stable treatment plan as judged by my doctor.I am 18 years old or older.I do not have a working email address.I have been treated for cancer with surgery, radiation, or drugs.I am currently taking buprenorphine or suboxone.It has been 5 years or less since I finished my cancer treatment.My pain medication dose has been stable for at least 14 days.I have been treated for invasive cancer, not just skin cancer or in situ malignancy.I am not planning to change my current cancer treatment for the next three months.My pain level is 4 or higher on the PROMIS scale.I can take care of myself and am up and about more than half of my waking hours.I do not have any surgeries or radiation treatments planned for the next 3 months.My pain started or got worse after my cancer diagnosis or treatment began.It has been over 4 weeks since my last major surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Pain Education Only
- Group 2: Internet-based program + Pain Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many locations is this trial being conducted?
"This trial is being conducted at the VCU Massey Cancer Center at Stony Point in Richmond, Hawaii, Queen's Cancer Center - Kuakini in Honolulu, Illinois, and Illinois CancerCare-Peru in Peru. 63 other locations are also participating."
Answered by AI
Are researchers looking for more test subjects?
"Yes, as of 9/2/2022 this clinical trial is still recruiting patients. 456 individuals are needed to participate and they can do so at any one of the 63 study sites across the nation."
Answered by AI
How many research subjects are being accepted into this trial?
"That is correct, the trial is still ongoing and actively recruiting patients. The information was first posted on May 13th, 2021 with the most recent update occurring September 2nd, 2022. 63 different centres are looking for 456 total patients."
Answered by AI
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