This is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Also proposed is a secondary focus on subjective and objective function, medication use, psychological distress, and coping.
Chemotherapy-induced peripheral neuropathy (CIPN) is a sensory polyneuropathy occurring in 50-75% of patients receiving neurotoxic chemotherapy that presents with varying degrees of paresthesia, dysesthesia, allodynia, hyperalgesia, and pain. For 30% of survivors, CIPN remains for a lifetime, often accompanied by morbidity, increased healthcare utilization, impaired functional and psychological status, strained relationships, and reduced quality of life. CIPN patients often present with multiple patterns of peripheral neuropathy owing to diversity in their causative etiologies, environmental factors, and patient-specific pathophysiology. Recent studies call for a shift in focus from solely etiologic characterization (e.g. drug mechanism based) to individual pain phenotyping that characterizes CIPN patients based on the reaction of the nervous system (e.g. pain processing). Given its high prevalence, complex presentation, absence of effective prevention, and few established therapies for addressing long-term symptoms, CIPN poses a major burden to patients/providers. Better understanding of CIPN's underlying biological and psychosocial mechanisms paired with enhanced access to effective interventions may lead to improved CIPN management. Cognitive behavioral pain coping skills training (PCST) has shown effectiveness for reducing pain-related suffering among patients with cancer pain as well as those experiencing various neuropathic symptoms-they target specific psychological processes known to contribute to pain, distress, and disability. Despite established effectiveness, in-person PCST interventions often are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, and travel requirements. There remains a need for evidence-based behavioral pain interventions for CIPN delivered with innovative methods to overcome treatment access barriers, reduce pain interference, and enhance quality of life/functioning. We developed an 8-week internet-delivered PCST program using an expert systems approach designed to retain essential features of in-person PCST that does not require therapist involvement-a concept increasingly important for providing socially-distant care amid the corona virus disease (COVID-19) pandemic. The published small trials investigating PCST for CIPN demonstrates promise of this approach for reducing the CIPN burden and justifies larger-scale testing of internet-based PCST for CIPN.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Participants in the intervention group will complete 8 weeks of pain coping skills training delivered online
Adherence Rate
Participant adherence in the pilot trial will be measured individually based on the number of modules completed, of the 8 possible modules, during the 12 week intervention period. Participants who complete 6 of the 8 modules will be considered "completers" of the program, though the percent adherence to the program would be 75%.
Time frame: Week 12
Retention Rate
Participant retention in the pilot trial will be based on the percentage of all participants that are retained in the trial overtime. If 100% of participants complete 100% of the modules, this would equate to a 100% retention rate.
Time frame: Week 12
Acceptability of the Intervention
Acceptability will be assessed based on two indicators: the ability to recruit the desired number of participants into the trial during the specified recruitment period (26 total participants) and based on assessments of participant satisfaction with the program. Participant satisfaction will be assessed via satisfaction surveys developed specifically for the online pain coping skills training intervention, with questions scored on a likert scale ranging from "not at all satisfied" to "very satisfied" for each unique aspect of the program.
Time frame: Week12
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Time frame: baseline
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 12
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Time frame: Week 24
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Time frame: Week 36
Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b - Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Medication and substance amount use
Medication and substance use will be monitored with diaries completed at multiple timepoints during the study, and using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS). The TAPS assesses substance use behaviors over the last 12 months.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - PROMIS Cognitive Function scale
Psychological distress will be assessed via the PROMIS Cognitive Function scale, a 4-item questionnaire that asks participants to report on how often they have experienced certain thoughts and cognitive processes over the last 7 days, scored on a likert scale from "never" to "very often".
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)
Psychological distress will be assessed via the General Anxiety Disorder scale (GAD 7) - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - Patient Health Questionnaire (PHQ 8)
Psychological distress will be assessed via the Patient Health Questionnaire (PHQ 8) - Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) -Total score ≥3 for first 2 questions suggests anxiety -Total score ≥3 for last 2 questions suggests depression.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Coping
Coping will be assessed via questionnaire designed specifically for the internet-based pain coping skills program featured in the intervention. Questions pertain to how well participants feel that have developed adaptive coping strategies related to their pain coping processes, as well as how often they incorporate new coping skills into daily life.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Spirituality
Spirituality will be assessed using the 38-item Brief Multidimensional Measure of Religiousness and Spirituality, which assesses spirituality across 11 domains, including: daily spiritual experiences; values and beliefs; forgiveness; private religious practices; religious and spiritual coping; religious support; religious and spiritual history; commitment; organizational religiousness, and overall self ranking.
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks