Coaching to Improve Care of Cancer Pain

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
VA Northern California Health Care System
Information provided by (Responsible Party):
Richard L. Kravitz, MD, MSPH, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00283166
First received: January 25, 2006
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Pain
Behavioral: Tailored Education and Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Official Title: Coaching to Improve Care of Cancer Pain

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Pain control 2, 6, and 12 weeks after the index visit [ Time Frame: Baseline, 2, 6, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain self-efficacy [ Time Frame: Baseline, 2, 6, 12 weeks ] [ Designated as safety issue: No ]
  • Communication self-efficacy [ Time Frame: Baseline, 2, 6, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Tailored Coaching and Education
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
B
Active Control
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283166

Locations
United States, California
VA Northern California Health Care System
Mather, California, United States, 95655
Kaiser Permanente Northern California
Oakland, California, United States, 94612
UC Davis Cancer Center
Sacramento, California, United States, 95818
Sponsors and Collaborators
University of California, Davis
Kaiser Permanente
VA Northern California Health Care System
Investigators
Principal Investigator: Richard L Kravitz, MD, MSPH UC Davis Center for Health Services Research in Primary Care
  More Information

Publications:
Responsible Party: Richard L. Kravitz, MD, MSPH, Professor, Internal Medicine, University of California, Davis
ClinicalTrials.gov Identifier: NCT00283166     History of Changes
Other Study ID Numbers: ACS-KRPC-0609, RSGPB-06-091-01-CPPB
Study First Received: January 25, 2006
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Palliative Care

ClinicalTrials.gov processed this record on September 18, 2014