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Reducing Barriers to Pain and Fatigue Management


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Fatigue, Lung Cancer, Pain, Prostate Cancer

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Trial Information

Reducing Barriers to Pain and Fatigue Management


OBJECTIVES:

- To test the effects of the Passport to Comfort (Passport) intervention at 1 and 3
months post-intervention by comparing baseline data to the high-intensity intervention.

- To test the effects of select demographic and disease/treatment variables on outcomes
of the Passport model at 1 and 3 months post-intervention compared to pre-intervention.

- To examine perceived patient and professional satisfaction with the Passport model.

- To test the effects of the Passport intervention by comparing high-intensity to
low-intensity.

OUTLINE: Patients are stratified according to cancer diagnosis (breast vs prostate vs colon
vs lung), pain level (< 4 vs ≥ 4 on pain scale), and fatigue level (< 4 vs ≥ 4 on fatigue
scale). Patients are assigned to 1 of 3 groups.

- Group 1 (enrolled during months 1-8): Patients undergo pain and fatigue assessment
periodically by demographic and treatment data, Quality of life-Patient Tool, BQII,
Piper Fatigue Scale, Pain and Fatigue Knowledge Tools, and Patient Satisfaction Tool.
Patients receive usual care and undergo pain and fatigue evaluation with no algorithms
or formal education. Research nurses conduct chart audits to identify professional and
system barriers but receive no medical education, peer review, or feedback. Medical
professionals undergo assessment periodically by a Demographic Data Tool, Pain and
Fatigue Knowledge Tools, Chart Audit Tool, and Provider Satisfaction.

- Group 2 (enrolled during months 9-30): Patients and medical professionals are assessed
periodically as in group 1. Patients undergo a high-intensity Passport intervention
with algorithms based on National Comprehensive Cancer Network (NCCN) guidelines, pain
and fatigue education once weekly for 4 weeks, and follow-up reinforcement phone calls
every 2 weeks. Research nurses conduct chart audits of congruence between practice and
guidelines, tape education sessions, and receive feedback from the principal
investigator in the form of a Tape-Monitoring Checklist. Medical oncologists attend
training on the use of the algorithms, peer review pain and fatigue management audit
with feedback, and reinforce and apply content in clinical rounds.

- Group 3 (enrolled during months 34-57): Patients and medical professionals are assessed
periodically as in group 1. Patients undergo a low-intensity Passport intervention as
in group 2. Medical professionals conduct realistic implementation of the intervention
into existing systems and procedures within the cancer center, less direct education
and system intervention, and share group 2 experiences.

After completion of study intervention, patients are followed at 1 and 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast, prostate, colon, or lung cancer (any stage)

- Diagnosed ≥ 1 month before study entry

- Reports pain and/or fatigue intensity ≥ 4 on a scale of 0-10

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Life expectancy ≥ 6 months

- Able to read and understand English

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Quality of life

Safety Issue:

No

Principal Investigator

Betty Ferrell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

04140

NCT ID:

NCT00900835

Start Date:

June 2005

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Fatigue
  • Lung Cancer
  • Pain
  • Prostate Cancer
  • fatigue
  • pain
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent colon cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent non-small cell lung cancer
  • recurrent small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Fatigue
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010