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

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ClinicalTrials.gov Identifier: NCT02791646
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
PCST-Full (Pain Coping Skills Training) PCST-Brief Behavioral: Pain Coping Skills Training Full Behavioral: Pain Coping Skills Brief Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
Study Start Date : November 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Pain Interference [ Time Frame: 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.

  2. Practicality as measured by accrual [ Time Frame: 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)

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

  4. Practicality as measured by adherence [ Time Frame: 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

  5. 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 ]
    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

  6. Cost-Effectiveness [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791646


Contacts
Contact: Tamara J Somers, Ph.D. 919-416-3408 tamara.somers@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Tamara J Somers, PhD    919-416-3408      
Principal Investigator: Tamara J Somers, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Tamara J Somers, Ph.D. Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02791646     History of Changes
Other Study ID Numbers: Pro00070823
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms