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An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462302
Recruitment Status : Not yet recruiting
First Posted : July 8, 2020
Last Update Posted : April 30, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Detailed 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. 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).

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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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : April 1, 2025

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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).

  2. 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 :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 history of a cancer diagnosis and treatment. Must have a documented diagnosis of invasive cancer requiring therapy with any combination of surgery, radiation, and chemotherapy/drug therapy including single modality therapy only. Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
  • Must have been ≥3 months, but not more than 24 months since the completion of definitive cancer therapy (i.e., time since the last day of chemotherapy administration) with either no evidence of residual disease or with stable disease, as established by imaging, clinical exam, or laboratory testing at the time of screening.
  • Must have completed all planned anticancer therapy with the exception of maintenance therapy when appropriate. Maintenance therapy includes planned chronic immunotherapy, hormonal therapy, targeted therapy or chemotherapy given to prevent recurrence of disease rather than to treat active disease (e.g. long-term PD-1 or PD-L1 inhibitors in NSCLC patients following initial chemotherapy). Time frame applies to the most recent completion of treatment if participant has experienced cancer recurrence(s).
  • 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 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 study period up to the 10 Week Follow-up Visit. 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.
  • Suspected or proven progressive cancer by clinical history, exam or imaging evaluation. [Must have stable disease or considered to have no evidence of disease (NED)].
  • 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
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Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu

Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Christine Rini, PhD         
Carle on Vermilion
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Suparna Mantha         
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Suparna Mantha         
Carle Cancer Center
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Suparna Mantha         
United States, Ohio
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
United States, South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Study Chair: Glenn Lesser, MD Wake Forest University Health Sciences
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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: April 30, 2021
Last Verified: April 2021
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

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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:
Cancer pain
Survivor
Pain
Pain coping