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New treatment option for Cancer
Official title An Internet-based Program to Help Cancer Survivors Manage Pain
ClinicalTrials.gov ID: NCT04462302
What this study is testing
- What it's testing
- To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery...
- May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
- Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period...
- Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks...
- A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
You likely can't join if
- Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence...
- Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders...
- Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving...
- Currently being prescribed buprenorphine or suboxone.
- Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an...
- Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided...
See the full eligibility criteria
Who can join
- Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted...
- May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
- Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.
- Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling...
- A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
- A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).
- In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome...
- Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last...
- Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
- Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
- Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen)...
- Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
- Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to...
- ECOG performance status of 0, 1, or 2.
- Age ≥18 years at the time of study entry
- Must be able to speak, read and understand English.
What rules you out
- Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of...
- Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
- Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented...
- Currently being prescribed buprenorphine or suboxone.
- Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care...
- Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
- Does not have a working email address.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Smith, Arkansas, United States
- Antioch, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Redwood City, California, United States
- Richmond, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- San Rafael, California, United States
- Santa Clara, California, United States
- Santa Rosa, California, United States
- South San Francisco, California, United States
- Stockton, California, United States
- Vacaville, California, United States
+ 102 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Smith, Arkansas, United States; Antioch, California, United States; Dublin, California, United States; Fremont, California, United States; Fresno, California, United States; Modesto, California, United States and 116 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.