PCST-Full (Pain Coping Skills Training)SMARTNCT02791646
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
A study testing Pain Coping Skills Training Full and Pain Coping Skills Brief in people with PCST-Full (Pain Coping Skills Training) and PCST-Brief, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PCST-Full (Pain Coping Skills Training), PCST-Brief
- What is being tested?
- Pain Coping Skills Training Full and Pain Coping Skills Brief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2016to 13 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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).
Read the 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).
- Being tested
- Pain Coping Skills Training Full, Pain Coping Skills Brief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coping Skills Training FullBehavioural
Pain Coping Skills Training Full(PCST-Full) will consist of a 5-session intervention delivered to participants at the medical center by their therapist.
Pain Coping Skills BriefBehavioural
Pain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging
| Study group | Role | What they receive |
|---|---|---|
| PCST-Full | Experimental | PCST-full will consist of a 5-session intervention delivered to participants at the medical center by their therapist. Receives: Behavioral: Pain Coping Skills Training Full |
| PCST-Brief | Experimental | Pain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging Receives: Behavioral: Pain Coping Skills Brief |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks, 3 months and 6 months
Secondary outcomes (6)
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.
Measured: 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)
Measured: 8 months
Practicality as measured by retention
Retention will be indicated by 80% of consented participants completing the study protocol (i.e., remain enrolled)
Measured: 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
Measured: 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
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start23 Nov 2016
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCST-Full (Pain Coping Skills Training)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara J Somers, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791646
- Sponsor's protocol ID
- Pro00070823
- Acronym
- SMART
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2016
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Reed SD, Winger JG, Hyland KA, Fisher HM, Kelleher SA, Miller SN, Davidian M, Laber EB, Keefe FJ, Somers TJ. Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer. J Pain. 2023 Sep;24(9):1712-1720. doi: 10.1016/j.jpain.2023.05.004. Epub 2023 May 13.
PubMed 37187219Kelleher 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.
PubMed 28408335
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
- ClinicalTrials.gov ID
- NCT02791646
- Acronym / sponsor ID
- SMART / Pro00070823
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCST-Full | Experimental | Behavioral: Pain Coping Skills Training FullPCST-full will consist of a 5-session intervention delivered to participants at the medical center by their therapist. |
| PCST-Brief | Experimental | Behavioral: Pain Coping Skills BriefPain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Coping Skills Training FullPain Coping Skills Training Full(PCST-Full) will consist of a 5-session intervention delivered to participants at the medical center by their therapist. | Behavioural | PCST-Full |
| Pain Coping Skills BriefPain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging | Behavioural | PCST-Brief |
Primary outcome
Change in Pain intensity
Time frame: 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
Time frame: 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.
6 secondary outcomes
Pain Interference
Time frame: Baseline, 6 weeks, 3 months and 6 months
Practicality as measured by accrual
Time frame: 8 months
Practicality as measured by retention
Time frame: 8 months
Practicality as measured by adherence
Time frame: 8 months
Pain Catastrophizing, as measured by the 6-item pain catastrophizing subscale of the Coping Strategies Questionnaire
Time frame: Baseline, 6 weeks, 3 months and 6 months
Cost-Effectiveness
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Derived from this study: PubMed 37187219Li Y, Reed SD, Winger JG, Hyland KA, Fisher HM, Kelleher SA, Miller SN, Davidian M, Laber EB, Keefe FJ, Somers TJ. Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer. J Pain. 2023 Sep;24(9):1712-1720. doi: 10.1016/j.jpain.2023.05.004. Epub 2023 May 13.
- Derived from this study: PubMed 28408335Kelleher 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara J Somers, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Coping Skills Training Full and Pain Coping Skills Brief in people with PCST-Full (Pain Coping Skills Training) and PCST-Brief, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (time frame: baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791646, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.