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Coaching to Improve Care of Cancer Pain

18 Years
80 Years
Not Enrolling

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Trial Information

Coaching to Improve Care of Cancer Pain

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Outcome Measure:

Pain control 2, 6, and 12 weeks after the index visit

Outcome Time Frame:

Baseline, 2, 6, and 12 weeks

Safety Issue:


Principal Investigator

Richard L Kravitz, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UC Davis Center for Health Services Research in Primary Care


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

December 2011

Related Keywords:

  • Pain
  • Palliative Care



UC Davis Cancer Center Sacramento, California  95817
VA Northern California Health Care System Mather, California  95655
Kaiser Permanente Northern California Oakland, California  94612