Completed

Reducing Barriers to Pain and Fatigue Management

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+35

+ Genital Diseases

+ Breast Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Interventional
Study Start: June 2005
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleReducing Barriers to Pain and Fatigue Management
NCT00900835
Principal SponsorCity of Hope Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

470 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBreast DiseasesBreast NeoplasmsBronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsFatigueGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteNeurologic ManifestationsPainProstatic DiseasesProstatic NeoplasmsRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSigns and SymptomsSkin DiseasesPathological Conditions, Signs and SymptomsThoracic NeoplasmsUrogenital NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesMale Urogenital DiseasesSmall Cell Lung Carcinoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

City of Hope Comprehensive Cancer Center

Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps
CompletedOne Study Center