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Coaching to Improve Care of Cancer Pain

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Education and Coaching
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Palliative Care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Northern California Health Care System
  • Kaiser Permanente Northern California
  • UC Davis Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

A

B

Arm Description

Tailored Coaching and Education

Active Control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain self-efficacy
Communication self-efficacy

Full Information

First Posted
January 25, 2006
Last Updated
June 7, 2017
Sponsor
University of California, Davis
Collaborators
Kaiser Permanente, VA Northern California Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00283166
Brief Title
Coaching to Improve Care of Cancer Pain
Official Title
Coaching to Improve Care of Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Kaiser Permanente, VA Northern California Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Palliative Care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Tailored Coaching and Education
Arm Title
B
Arm Type
Other
Arm Description
Active Control
Intervention Type
Behavioral
Intervention Name(s)
Tailored Education and Coaching
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain control 2, 6, and 12 weeks after the index visit
Time Frame
Baseline, 2, 6, and 12 weeks
Secondary Outcome Measure Information:
Title
Pain self-efficacy
Time Frame
Baseline, 2, 6, 12 weeks
Title
Communication self-efficacy
Time Frame
Baseline, 2, 6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Kravitz, MD, MSPH
Organizational Affiliation
UC Davis Center for Health Services Research in Primary Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
UC Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95818
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19737424
Citation
Kravitz RL, Tancredi DJ, Street RL Jr, Kalauokalani D, Grennan T, Wun T, Slee C, Evans Dean D, Lewis L, Saito N, Franks P. Cancer Health Empowerment for Living without Pain (Ca-HELP): study design and rationale for a tailored education and coaching intervention to enhance care of cancer-related pain. BMC Cancer. 2009 Sep 9;9:319. doi: 10.1186/1471-2407-9-319.
Results Reference
background
PubMed Identifier
19962845
Citation
Street RL Jr, Slee C, Kalauokalani DK, Dean DE, Tancredi DJ, Kravitz RL. Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns. 2010 Jul;80(1):42-7. doi: 10.1016/j.pec.2009.10.009. Epub 2009 Dec 4.
Results Reference
result

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Coaching to Improve Care of Cancer Pain

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