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NCORP Trials

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

Status
Active
Cancer Type
Cancer Control
Trial Phase
Phase III
Eligibility
18 years and older, male and female, Male and Female
Study Type
Treatment
Other
NCD ID
NCT04462302
Protocol IDs
WF-1901 (primary)
NCI-2020-02315
Study Sponsor
WAKE
NCI Full Details
https://clinicaltrials.gov/ct2/show/NCT04462302?term=wf1901&draw=2&rank=1

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.
 

Objectives

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.

 
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