Trial record 1 of 1 for:
wf1901
An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)
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| ClinicalTrials.gov Identifier: NCT04462302 |
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Recruitment Status :
Recruiting
First Posted : July 8, 2020
Last Update Posted : March 10, 2023
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Sponsor:
Wake Forest University Health Sciences
Collaborators:
National Cancer Institute (NCI)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Behavioral: Internet-based pain coping skills program | Not Applicable |
This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 456 participants will be enrolled (228 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.
Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 456 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Internet-delivered Management of Pain Among Cancer Treatment Survivors |
| Actual Study Start Date : | May 13, 2021 |
| Estimated Primary Completion Date : | October 1, 2024 |
| Estimated Study Completion Date : | April 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Internet-based program + Pain Education
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.
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Behavioral: Internet-based pain coping skills program
The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain. |
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No Intervention: Pain Education Only
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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Primary Outcome Measures :
- Pain Severity [ Time Frame: Change from Baseline to 10 week ]The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
- Pain Interference [ Time Frame: Change from Baseline to 10 week ]The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
Secondary Outcome Measures :
- Pain Severity [ Time Frame: 22 and 34 weeks ]The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
- Pain Interference [ Time Frame: 22 and 34 weeks ]The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
- Opioid/analgesic medication use [ Time Frame: Baseline and 10 week ]A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).
- Opioid/analgesic medication use [ Time Frame: Baseline, 10, 22, and 24 week ]7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).
- Health-Related Quality of Life [ Time Frame: Baseline, 10, 22, and 24 week ]Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.
- Pain Management Self-Efficacy [ Time Frame: Baseline, 10, 22, and 24 week ]Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
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May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive as per treating clinician judgement at the time of screening.
- Patients who are actively receiving anticancer therapy at the time of screening should not have plans in place to change to another therapy for the duration of the delivered intervention period (i.e., the three month leading up to primary outcome evaluation.)
- Patients who are actively receiving anticancer therapy at the time of screening must have been on that therapy for a minimum of four weeks prior to enrollment (i.e., no change in anticancer therapy in the previous month).
- 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 evaluation-timepoint.
- 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 day of radiotherapy, etc.).
- 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) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
- 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 develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).
- 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.
Exclusion Criteria:
- 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 severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
- 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 in the medical record.
- 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 concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462302
Contacts
| Contact: Karen Craver | 336-716-0891 | NCORP@wakehealth.edu |
Locations
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Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Study Chair: | Glenn Lesser, MD | Wake Forest University Health Sciences |
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT04462302 |
| Other Study ID Numbers: |
IRB00066906 3UG1CA189824-06S1 ( U.S. NIH Grant/Contract ) WF-1901 ( Other Identifier: Wake Forest NCORP Research Base ) NCI-2020-02315 ( Registry Identifier: NCI CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | July 8, 2020 Key Record Dates |
| Last Update Posted: | March 10, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514. |
| Time Frame: | 6 months after publication for a 2 year duration |
| Access Criteria: | upon request to NCORP@wakehealth.edu |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Wake Forest University Health Sciences:
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Cancer pain Survivor Pain Pain coping |