Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART (SMART)

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).

Study Overview

• Status: Completed
• Conditions: PCST-Full (Pain Coping Skills Training); PCST-Brief
• Intervention / Treatment: Behavioral: Pain Coping Skills Training Full; Behavioral: Pain Coping Skills Brief

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).

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCST-Full; PCST-full will consist of a 5-session intervention delivered to participants at the medical center by their therapist.	Behavioral: Pain 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.
Experimental: PCST-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	Behavioral: Pain 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Practicality as measured by retention	Retention will be indicated by 80% of consented participants completing the study protocol (i.e., remain enrolled)	8 months
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Tamara J Somers, Ph.D., Duke University

Publications and helpful links

General Publications

• Kelleher SA, Dorfman CS, Plumb Vilardaga JC, Majestic C, Winger J, Gandhi V, Nunez C, Van Denburg A, Shelby RA, Reed SD, Murphy S, Davidian M, Laber EB, Kimmick GG, Westbrook KW, Abernethy AP, Somers TJ. Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART. Contemp Clin Trials. 2017 Jun;57:51-57. doi: 10.1016/j.cct.2017.04.001. Epub 2017 Apr 11.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2016
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimated): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: Pro00070823