Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

Primary

• Pain Interference

  PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference.

  Time frame: Baseline, 4 weeks, 8 weeks

• Pain Intensity

  PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.

  Time frame: Baseline, 4 weeks, 8 weeks

• Pain Inventory

  Brief Pain Inventory (BPI) survey. Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain. For pain levels, various questions ask participants to rate pain on a scale of 0-10, 0 being no pain and 10 being pain as bad as you can imagine. For questions about pain interference, each question is on a scale of 0-10, where 0 does not interfere and 10 completely interferes. BPI is scored as an average of each subsection, where a higher average suggests greater severity of pain/more interference.

  Time frame: Baseline, 4 weeks, 8 weeks

• Sleep Disturbance

  PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.

  Time frame: Baseline, 4 weeks, 8 weeks

• Sleep-Related Impairment

  PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment

  Time frame: Baseline, 4 weeks, 8 weeks

• Depression/Anxiety

  Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.

  Time frame: Baseline, 4 weeks, 8 weeks

• Fatigue

  PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue.

  Time frame: Baseline, 4 weeks, 8 weeks

• Health Related Quality of Life

  Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health.

  Time frame: Baseline, 4 weeks, 8 weeks

• FACT-Cog Cognitive Function

  Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.

  Time frame: Baseline, 4 weeks, 8 weeks

• Stroop Task Test of Cognitive Function

  Stroop Task

  Time frame: Baseline, 4 weeks, 8 weeks

• DSST Test of Cognitive Function

  Digit Symbol Substitution Task (DSST)

  Time frame: Baseline, 4 weeks, 8 weeks

• Conners Test of Cognitive Function

  Conners Continuous Performance Test - Version 3 (CPT-3)

  Time frame: Baseline, 4 weeks, 8 weeks

• Plasma Cannabinoids

  Plasma cannabinoid levels in participants will be measured from biological samples.

  Time frame: Baseline, 4 weeks, 8 weeks

• PROMIS Pain Intensity (Right Now)

  PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (Right Now). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.

  Time frame: 4 weeks

• Drug Effects

  Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.

  Time frame: 4 weeks

• ARCI-Marijuana Scale

  Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.

  Time frame: 4 weeks

• Drug Effects - Mood

  Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.

  Time frame: 4 weeks

• Drug Effects - Blood Cannabinoids

  Acute plasma cannabinoid levels in participants will be measured from blood samples pre-drug administration, on-hour post drug administration, and 2-hours post drug administration at week 4 appointment.

  Time frame: 4 weeks