NCT00283166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

January 25, 2006

Last Update Submit

June 7, 2017

Conditions

Pain

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 2, 6, and 12 weeks

Secondary Outcomes (2)

  • Pain self-efficacy

    Baseline, 2, 6, 12 weeks

  • Communication self-efficacy

    Baseline, 2, 6, 12 weeks

Study Arms (2)

A

EXPERIMENTAL

Tailored Coaching and Education

Behavioral: Tailored Education and Coaching

B

OTHER

Active Control

Behavioral: Tailored Education and Coaching

Interventions

Tailored Education and CoachingBEHAVIORAL

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

AB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Northern California Health Care System

Mather, California, 95655, United States

Location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

UC Davis Cancer Center

Sacramento, California, 95818, United States

Location

Related Publications (2)

  • 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.

    PMID: 19737424BACKGROUND

  • 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.

    PMID: 19962845RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard L Kravitz, MD, MSPH

    UC Davis Center for Health Services Research in Primary Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2009

Study Completion

December 1, 2011

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(3)