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Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART

NCT02791646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2023-08-07

No results posted yet for this study

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).

Conditions

  • PCST-Full (Pain Coping Skills Training)
  • PCST-Brief

Interventions

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.

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

Sponsors & Collaborators

Principal Investigators

  • Tamara J Somers, Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-23
Primary Completion
2021-08-13
Completion
2021-08-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02791646 on ClinicalTrials.gov