Breast CancerNCT00900835
Pain and Fatigue Management in Patients With Breast Cancer, Prostate Cancer, Colon Cancer, or Lung Cancer
A study testing educational intervention, questionnaire administration and study of socioeconomic and demographic variables in people with Breast Cancer and Colorectal Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may improve quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Fatigue
- What is being tested?
- educational intervention, questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Reducing Barriers to Pain and Fatigue Management
RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may improve quality of life.
PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast cancer, prostate cancer, colon cancer, or lung cancer.
Read the detailed description
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.
- Conditions
- Breast Cancer, Colorectal Cancer, Fatigue, Lung Cancer, Pain, Prostate Cancer
- Being tested
- educational intervention, questionnaire administration, study of socioeconomic and demographic variables, assessment of therapy complications, fatigue assessment and management
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Fatigue, Lung Neoplasms, Pain, Prostatic Neoplasms, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
assessment of therapy complicationsProcedure or surgery
fatigue assessment and managementProcedure or surgery
quality-of-life assessmentProcedure or surgery
standard follow-up careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Pain knowledge of patients and professionals
Fatigue knowledge of patients and professionals
Adherence to algorithm by patients, professionals, and system
Satisfaction of patients and professionals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2005
- Primary completionSep 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Betty Ferrell, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900835
- Sponsor's protocol ID
- 04140
- Other IDs
- R01CA115323, P30CA033572, CHNMC-04140, CDR0000628799
- Status last verified
- Mar 2011
- First submitted
- 12 May 2009
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers to Pain and Fatigue Management
- ClinicalTrials.gov ID
- NCT00900835
- Acronym / sponsor ID
- 04140
- Conditions
- Breast Cancer, Colorectal Cancer, Fatigue, Lung Cancer, Pain, Prostate Cancer
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may improve quality of life.
PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast cancer, prostate cancer, colon cancer, or lung cancer.
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| fatigue assessment and management | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
Primary outcome
Quality of life
Pain knowledge of patients and professionals
Fatigue knowledge of patients and professionals
Adherence to algorithm by patients, professionals, and system
Satisfaction of patients and professionals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Ferrell, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, questionnaire administration and study of socioeconomic and demographic variables in people with Breast Cancer and Colorectal Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.