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.