PCST-Brief Clinical Trial
— SMARTOfficial title:
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
| Verified date | August 2023 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is a sequential multiple assignment randomized trial (SMART), that will examine response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills Training [PCST]) and subsequent response-based adjustments to doses. Cancer patients with pain will initially be randomized to receive either PCST-Full or PCST-Brief. Participants who do not report pain reduction to their initially assigned intervention will be re-randomized to receive either maintenance or an increased level of intervention. Participants who report pain reduction to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment. Intervention responses will be compared across conditions using a standard two-sided, two-sample t-test. Techniques typically used for SMART studies will be used to compare intervention dosage sequences across PCTS that adjusts to initial dosage based on patient responses. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
| Status | Completed |
| Enrollment | 327 |
| Est. completion date | August 13, 2021 |
| Est. primary completion date | August 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - diagnosis of breast cancer (initial or recurrence) within the last two years - being >18 years old - having a life expectancy of at least 12 months - having a pain intensity rating of >5. Exclusion Criteria: - cognitive impairment - metastases to the brain - presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff - current or past (<6 months) engagement in PCST for cancer. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Pain intensity | Pain intensity will be assessed by asking patients about their pain at its "worst", "least", "average", and "now". Patients will answer on a scale where 0 = "no pain" to 10 = "pain as bad as you can imagine". The worst, least, and average items will be asked in reference to the last 7 days. A composite averaged score of these four items will be used to represent pain intensity. | baseline to 6 weeks | |
| Primary | Change in Pain Intensity | Pain intensity will be assessed by asking patients about their pain at its "worst", "least", "average", and "now". Patients will answer on a scale where 0 = "no pain" to 10 = "pain as bad as you can imagine". The worst, least, and average items will be asked in reference to the last 7 days. A composite averaged score of these four items will be used to represent pain intensity. | Baseline, 6 weeks, 3 months and 6 months | |
| Secondary | Pain Interference | Pain interference will be assessed with the Brief Pain Inventory (BPI). Pain interference will be assessed by asking patients how much their pain has interfered with seven daily activities including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep within the last 7 days. Answers will be on a 0 = "does not interfere" to 10 = "completely interferes" scale; items will be averaged to represent pain interference. These measures have been recommended for use in chronic-pain clinical trials. | Baseline, 6 weeks, 3 months and 6 months | |
| Secondary | Practicality as measured by accrual | Accrual will be indicated by meeting the recruitment goal of 327 participants during the proposed 48 months of recruitment (~7 participants per month) | 8 months | |
| Secondary | Practicality as measured by retention | Retention will be indicated by 80% of consented participants completing the study protocol (i.e., remain enrolled) | 8 months | |
| Secondary | Practicality as measured by adherence | Adherence for patients who are accrued to the study will be examined by calculating the proportion successfully completing all intervention sessions during their first randomization and second randomization | 8 months | |
| Secondary | Pain Catastrophizing, as measured by the 6-item pain catastrophizing subscale of the Coping Strategies Questionnaire | These items ask about patients tendency to catastrophizing when faced with pain (e.g., "When I feel pain it is awful and it overwhelms me") and are answered on a 0 = never to 6 = always scale. Items are summed for a total score | Baseline, 6 weeks, 3 months and 6 months | |
| Secondary | Cost-Effectiveness | We will create a composite cost variable based on patient time, provider time, and the EQ-5D.The EQ-5D is a measure of health status that can be linked to population-based preference weights is widely used in economic evaluations. It is short, assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The respondent indicates no problems, some problems, or severe problems in each dimension. | 8 months |