NCT00708019

Brief Summary

This study will test two different doses of a psychoeducational intervention to improve cancer pain management. In addition, the study will determine if the changes in pain management behaviors that the patients and family caregivers learn continue to be used when the intervention stops. It is hypothesized that patients and family caregivers who receive the high dose intervention will have a greater decrease in pain intensity scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 5, 2016

Completed
Last Updated

May 5, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

June 30, 2008

Results QC Date

January 22, 2015

Last Update Submit

April 1, 2016

Conditions

CancerPain

Keywords

cancer painbone metastasispsychoeducational interventionnurse coachingpatient educationbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Average Pain Intensity Score

    Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis. Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks).

    10 weeks

Secondary Outcomes (1)

  • Worst Pain Intensity Score

    10 weeks

Study Arms (2)

Low dose

EXPERIMENTAL

Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)

Behavioral: PRO-SELF PLUS Pain Management Program

High dose

EXPERIMENTAL

High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)

Behavioral: PRO-SELF PLUS Pain Management Program

Interventions

PRO-SELF PLUS Pain Management ProgramBEHAVIORAL

The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

High doseLow dose

Eligibility Criteria

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

You may qualify if:

  • adult oncology outpatients (\> 18 years of age)
  • able to read, write, and understand English
  • agree to participate and give informed consent
  • have a KPS Score of \> 50
  • have an average pain intensity score of \> 3.0 on a 0 to 10 NRS
  • have radiographic evidence of bone metastasis
  • visceral or somatic pain
  • have a life expectancy of at least 6 months
  • are receiving outpatient treatment for cancer (not AIDS-related) with any single or combination therapy, and have a telephone line

You may not qualify if:

  • A documented previous or current psychiatric disorder or if at the time of recruitment they are receiving hospice care in order not to interfere with the pain management program provided by hospice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

UCSF Helen Diller Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

NeoplasmsPainCancer PainBreast Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Christine Miaskowski
Organization
University of California, San Francisco
chris.miaskowski@nursing.ucsf.edu
415-476-9407

Study Officials

  • Christine A. Miaskowski, RN, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 2, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

May 5, 2016

Results First Posted

May 5, 2016

Record last verified: 2016-04

Locations

US(2)