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Coaching to Improve Care of Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283166
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : June 9, 2017
Sponsor:
Collaborators:
Kaiser Permanente
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE January 25, 2006
First Posted Date  ICMJE January 27, 2006
Last Update Posted Date June 9, 2017
Study Start Date  ICMJE November 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
Pain control 2, 6, and 12 weeks after the index visit [ Time Frame: Baseline, 2, 6, and 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2006)
Pain control 2, 6, and 12 weeks after the index visit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
  • Pain self-efficacy [ Time Frame: Baseline, 2, 6, 12 weeks ]
  • Communication self-efficacy [ Time Frame: Baseline, 2, 6, 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2006)
Improved management of other symptoms (eg, nausea, constipation, fatigue)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coaching to Improve Care of Cancer Pain
Official Title  ICMJE Coaching to Improve Care of Cancer Pain
Brief Summary An estimate of 90% of patients with cancer experience at least moderate pain at some point in their illness, and 42% of patients do not receive adequate palliation. The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers. The aims of the study are: 1) to compare the effects on pain, cancer-related symptoms, and health-related quality of life of a standard cancer pain leaflet versus face-to-face, tailored education and coaching; 2) to estimate the effect of tailored education and coaching on patients' self confidence for managing their pain and participating actively in care; and 3) to examine the mechanisms underlying the beneficial effects of the intervention. The proposed model will enhance research on pain management in that it is a pilot-tested intervention that is applicable in the outpatient setting, based on Social Cognitive Theory, and focused on patient activation and education.
Detailed Description

Background: A small, randomized trial was conducted in 2001, that supplied preliminary evidence that a carefully structured, one-time individualized education and coaching intervention has the potential to provide important clinical benefits for patients suffering from cancer-related pain. The study did not explore the impact of the intervention in a larger, more diverse patient population; the duration of the intervention's benefits; or the pathway by which the benefits are achieved. This project will attempt to address these issues while building on the literature that exists in palliation and physician-patient communication.

Objective/Hypothesis: The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers.

Specific Aims: The aims of this study are: 1) to compare the effects on pain, cancer-related symptoms, and health-related quality of life of a standard educational intervention versus face-to-face, tailored education and coaching; 2) to estimate the effect of tailored education and coaching on self-efficacy for pain self-management and for participation in care; and 3) to examine the mechanisms underlying the beneficial effects of the intervention.

Study Design: The proposed study is a randomized, controlled trial comparing "education only" with tailored education and coaching for patient activation (TEC). Eligible patients scheduled to see their oncologist at any of the three participating health systems will be invited to participate in the study. Consenting patients will be randomly allocated to TEC or education only. The intervention will be applied during a brief session just before the scheduled oncology visit. Allocation will be concealed from physicians, interviewers, and data analysts. Patients assigned to the usual care group will review the content of a standard informational booklet on cancer pain. A health educator will review key learning points and be available to answer questions. Patients assigned to the TEC group will receive an intervention designed to improve self-efficacy for both pain self-management and participation in care. Data will be collected from patients in a private waiting alcove just prior to the index visit (personal interview); during the index visit (audio-taping); and then two, six, and 12 weeks after the visit (phone interview). In addition to assessing effectiveness of the intervention, the study is designed to measure potential mediators and intermediate outcomes (attitudes, beliefs, self-efficacy, patient participation, quality of care, and adherence) and to examine the mechanisms underlying the intervention's beneficial effects. The study will contribute to a test of Social Cognitive Theory by examining whether the benefit of the intervention is more powerfully attenuated by changes in attitudes and beliefs or by changes in self-efficacy.

Cancer Relevance: Uncontrolled cancer pain remains prevalent. An estimated 90% of patients with cancer experience at least moderate pain at some point in their illness, and 42% of patients do not receive adequate palliation. Aside from impairing quality of life, uncontrolled pain can contribute to depression, increase the likelihood of suicide, and decrease patient acceptance of potentially beneficial therapy. The proposed project is valuable in that it will confirm the benefit of patient coaching, elucidate its mechanisms, and test Social Cognitive Theory. The proposed model will enlarge existing research on pain management in that it is: a (1) pilot tested, easily implementable intervention that is (2) applicable in the outpatient setting, (3) based on strong theory that makes predictions about mechanisms of benefit, and (4) focused on patient activation as well as education.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Pain
Intervention  ICMJE Behavioral: Tailored Education and Coaching
A: Patients receive one-on-one counseling and education about pain management and improving doctor-patient communication B: Patients receive booklet on cancer pain control
Study Arms  ICMJE
  • Experimental: A
    Tailored Coaching and Education
    Intervention: Behavioral: Tailored Education and Coaching
  • B
    Active Control
    Intervention: Behavioral: Tailored Education and Coaching
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2009)
258
Original Enrollment  ICMJE
 (submitted: January 25, 2006)
230
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Seen or scheduled to be seen at participating facility
  • Diagnosis of locally advanced or disseminated lung, breast, prostate, head and neck, gynecologic (ovarian, uterine, cervical), esophageal, or colorectal cancer
  • English speaking
  • Worst pain past two weeks 4/10 or higher

Exclusion Criteria:

  • Major surgical procedure scheduled within six weeks
  • Enrolled in hospice
  • Followed by pain management service (more than one visit made or scheduled)
  • Already contacted for study
  • Positive six-item dementia screen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283166
Other Study ID Numbers  ICMJE 224690
RSGPB-06-091-01-CPPB
ACS-KRPC-0609 ( Other Identifier: UC Davis )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • Kaiser Permanente
  • VA Northern California Health Care System
Investigators  ICMJE
Principal Investigator: Richard L Kravitz, MD, MSPH UC Davis Center for Health Services Research in Primary Care
PRS Account University of California, Davis
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP