Cancer PainNCT01230515
Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol
An observational study of Cancer Pain, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Individual patient interview, focus group and structured survey and interview, focus group and structured survey
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2008
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospice Staff Caregiver Patient Referring Physician
Who may be able to join
- Patient eligibility includes:
- Alive Hospice outpatient
- Diagnosis of carcinoma
- Pain requiring fixed dose opioids
- Age > 21 years
- Not pregnant or lactating
Show all 19Show fewer
- Willing and able to sign informed consent
- Able to speak/comprehend English
- Caregiver eligibility will include:
- Caregiver for an Alive Hospice patient
- Willing and able to sign informed consent
- Able to speak/comprehend English
- Hospice Staff eligibility will include:
- Currently on staff at Alive Hospice
- Willing and able to sign informed consent
- Able to read/speak English.
- Referring Physician eligibility will include:
- Having recently referred patients to Alive Hospice
- Willing and able to sign informed consent and able to read/speak English.
Who cannot join
- patients < 21 years of age
- pregnant or lactating
- patients, caregiver and or Hospice staff that does not speak/comprehend English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.
- Conditions
- Cancer Pain
- Being tested
- Individual patient interview, focus group and structured survey, interview, focus group and structured survey
- Keywords
- Oncology Pain Management in outpatient hospice setting
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual patient interview, focus group and structured surveyOther
interview, focus group and structured surveyOther
interview, focus group and structured surveyOther
interview, focus group and structured surveyOther
| Study group | Role | What they receive |
|---|---|---|
| Caregiver | Family members will be asked to complete a demographic survey, an assessment of the patient's current pain, and a series of questionnaires including: Caregiver Pain Medicine Questionnaire, the Stressful Caregiving Adult Reactions To Experiences of Dying Scale, and the Caregivers' Self Efficacy in Pain Management Questionnaire. Upon completion of the questionnaires, patients and caregivers will be interviewed separately. Receives: Other: interview, focus group and structured survey | |
| Hospice staff | Hospice staff will be asked to complete the Pain Knowledge and Attitudes survey. They will also complete the Technology Acceptance Model (TAM) questionnaire to assess the perceived utility of an opioid titration order sheet to help manage pain control. A demographic survey will also be completed. Receives: Other: interview, focus group and structured survey | |
| Referring physician | Referring physicians will be asked to complete the Pain Knowledge and Attitudes survey as well as the TAM questionnaire and Demographic Survey. Receives: Other: interview, focus group and structured survey | |
| Patient | Demographic information includes education, marital status, number in household, and employment status will be obtained from patient. Clinical data will be obtained from the patient's medical records. Information to be obtained will include information about the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription. The patient will also take a pain assessment survey. Receives: Other: Individual patient interview, focus group and structured survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate pain control
Measured: Until death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara Murphy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230515
- Sponsor's protocol ID
- VICC SUPP 0566
- Other IDs
- P30CA068485
- Status last verified
- Sep 2012
- First submitted
- 11 Oct 2010
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol
- ClinicalTrials.gov ID
- NCT01230515
- Acronym / sponsor ID
- VICC SUPP 0566
- Conditions
- Cancer Pain
- Keywords
- Oncology Pain Management in outpatient hospice setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Oct 2010 (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.
The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caregiver | – | Other: interview, focus group and structured surveyFamily members will be asked to complete a demographic survey, an assessment of the patient's current pain, and a series of questionnaires including: Caregiver Pain Medicine Questionnaire, the Stressful Caregiving Adult Reactions To Experiences of Dying Scale, and the Caregivers' Self Efficacy in Pain Management Questionnaire. Upon completion of the questionnaires, patients and caregivers will be interviewed separately. |
| Hospice staff | – | Other: interview, focus group and structured surveyHospice staff will be asked to complete the Pain Knowledge and Attitudes survey. They will also complete the Technology Acceptance Model (TAM) questionnaire to assess the perceived utility of an opioid titration order sheet to help manage pain control. A demographic survey will also be completed. |
| Referring physician | – | Other: interview, focus group and structured surveyReferring physicians will be asked to complete the Pain Knowledge and Attitudes survey as well as the TAM questionnaire and Demographic Survey. |
| Patient | – | Other: Individual patient interview, focus group and structured surveyDemographic information includes education, marital status, number in household, and employment status will be obtained from patient. Clinical data will be obtained from the patient's medical records. Information to be obtained will include information about the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription. The patient will also take a pain assessment survey. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospice Staff Caregiver Patient Referring Physician
Key inclusion criteria (19 listed)
- Patient eligibility includes:
- Caregiver for an Alive Hospice patient
- Willing and able to sign informed consent
- Able to speak/comprehend English
- Currently on staff at Alive Hospice
Key exclusion criteria (3 listed)
- patients < 21 years of age
- pregnant or lactating
- patients, caregiver and or Hospice staff that does not speak/comprehend English
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 |
|---|---|---|
| Individual patient interview, focus group and structured survey | Other | Patient |
| interview, focus group and structured survey | Other | Caregiver |
| interview, focus group and structured survey | Other | Hospice staff |
| interview, focus group and structured survey | Other | Referring physician |
Primary outcome
Adequate pain control
Time frame: Until death.
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 10 Sep 2012.
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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.
Barbara Murphy, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain, run by Vanderbilt-Ingram Cancer 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?
The sponsor lists 19 inclusion and 3 exclusion criteria. 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 10 Sep 2012. 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?
Adequate pain control (time frame: Until death.). 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 10 Sep 2012.