PCST-Brief, PCST-Full (Pain Coping Skills Training)
Conditions
Brief summary
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).
Detailed description
The incidence of moderate to severe pain in cancer patients remains greater than 50%. NIH guidelines recommend the implementation of behavioral cancer pain interventions into patient care. Yet, implementation remains low. Evidence on patient dose-response (i.e., number of sessions, skills), intervention adaption based on initial response, and understanding personal characteristics related to differing dose-response can improve implementation by optimizing behavioral intervention delivery. 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 (N=327) will initially be randomized to receive either PCST-Full or PCST-Brief. Participants who do not respond (\<30% pain reduction) to their initially assigned intervention will be re-randomized to receive either maintenance (i.e., booster sessions focused on problem solving and skills reinforcement) or an increased level of intervention (i.e., additional sessions and skills). Participants who respond (\> 30% pain reduction) to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment. Intervention responses will be (% reduction in pain) 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).
Interventions
BEHAVIORALPain Coping Skills Training Full
Pain Coping Skills Training Full(PCST-Full) will consist of a 5-session intervention delivered to participants at the medical center by their therapist.
BEHAVIORALPain Coping Skills Brief
Pain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain intensity | baseline to 6 weeks | 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. |
| Change in Pain Intensity | Baseline, 6 weeks, 3 months and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Practicality as measured by retention | 8 months | Retention will be indicated by 80% of consented participants completing the study protocol (i.e., remain enrolled) |
| Practicality as measured by adherence | 8 months | 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 |
| Pain Interference | Baseline, 6 weeks, 3 months and 6 months | 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. |
| Cost-Effectiveness | 8 months | 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. |
| Pain Catastrophizing, as measured by the 6-item pain catastrophizing subscale of the Coping Strategies Questionnaire | Baseline, 6 weeks, 3 months and 6 months | 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 |
| Practicality as measured by accrual | 8 months | Accrual will be indicated by meeting the recruitment goal of 327 participants during the proposed 48 months of recruitment (\ 7 participants per month) |
Countries
United States
Outcome results
None listed