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.
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 250 participants will be enrolled (125 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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
456
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.
Pain Severity
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).
Time frame: Change from Baseline to 10 week
Pain Interference
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).
Time frame: Change from Baseline to 10 week
Pain Severity
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).
Time frame: 22 and 34 weeks
Pain Interference
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).
Time frame: 22 and 34 weeks
Opioid/analgesic medication use
A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).
Time frame: Baseline and 10 week
Opioid/analgesic medication use
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
...and 140 more locations
Time frame: Baseline, 10, 22, and 24 week
Health-Related Quality of Life
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.
Time frame: Baseline, 10, 22, and 24 week
Pain Management Self-Efficacy
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.
Time frame: Baseline, 10, 22, and 24 week