PainNCT00609297
Pain Control in Hospice Patients With Cancer-Related Pain
An observational study of Pain and Solid Tumor, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Gathering information over time about cancer-related pain from patients in a hospice and their caregivers may help doctors learn more about pain control. PURPOSE: This clinical trial is studying how well standard pain control works in hospice patients with cancer-related pain. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Solid Tumor
- What is being tested?
- medical chart review, questionnaire administration and survey administration
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2011
- 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: Patients in Alive hospice who have pain and their caregivers.
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 11Show 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
Who cannot join
- PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part A
RATIONALE: Gathering information over time about cancer-related pain from patients in a hospice and their caregivers may help doctors learn more about pain control.
PURPOSE: This clinical trial is studying how well standard pain control works in hospice patients with cancer-related pain.
Read the detailed description
OBJECTIVES:
- To obtain prospective data describing standard pain management methods and outcomes in the hospice setting.
OUTLINE: Data regarding pain and pain management is obtained from three sources: the patient, the caregiver(s), and the medical records.
- Patient assessment*: At baseline, patients provide demographic data and complete the Pain Assessment Form verbally via interview. The form addresses average pain, worst pain, pain relief, hours in pain, pain-related distress, and barriers to pain control. Patients are asked to rate pain control. Patients also complete the Pain Communication Survey to assess how they communicate with health care providers about their pain. After the baseline assessment is completed, pain is assessed by the research nurse through home visits* 3 times weekly and telephone interviews twice weekly. During each visit or telephone contact, patients are interviewed to complete the Pain Assessment Form. Patients are followed until the time of death.
NOTE: *If a patient is not available for the scheduled home visit, the interview will take place over the phone; if a patient is hospitalized or transferred to the inpatient hospice facility, the patient interview will take place there.
- Primary caregiver assessment**: At baseline, primary caregivers complete a demographic survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain Management Scale (CSEPMS), the Caregiver Pain Management Questionnaire (CPMQ), and the Stressful Caregiver Adult Reactions to Experiences of Dying (SCARED). Caregivers are then interviewed by the study nurse using the Pain Assessment Form as a guideline. Follow-up data from caregivers is obtained through a daily diary, interviews, and structured surveys. Primary caregivers complete the Pain Assessment Form daily and are instructed to provide their assessment of the patient's pain. In addition, caregivers are interviewed daily by a study nurse, who reviews the daily Pain Assessment Form and obtains detailed information regarding the adequacy of patient pain control, side effects of medication, barriers to pain control, and caregiver concerns and burdens. Primary caregivers also complete CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4 as part of follow-up. Primary caregivers are contacted after the patient's death to assess pain control at the time of death.
- Secondary caregiver assessment: At baseline, secondary caregivers complete the same baseline evaluation as primary caregivers over the phone. They complete the Pain Assessment Form weekly and the CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4. Secondary caregivers also undergo a post-mortem interview based on the Pain Assessment Form.
- Chart review: Chart review is conducted by the research Nurse after a patient's death. Cancer and cancer-related treatment are obtained and documentation about pain management is recorded. From the time of study entry, all staff notes are reviewed to document: pain assessment, calls to physicians or other support personnel (including pharmacy calls), identified barriers to pain control, and treatment modifications (including medications to treat side effects).
NOTE: **Patients and primary caregivers are interviewed independently.
- Conditions
- Pain, Solid Tumor
- Being tested
- medical chart review, questionnaire administration, survey administration
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Also called None specified
The Research Nurse will conduct a chart review after the patient's death.
questionnaire administrationOther
Also called None Specified
The questionnaires will be completed at the end of week 1, week 2 and week 4.
survey administrationOther
Also called none specified
Given to patient and caregivers throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Alive Hospice Patients with Pain Receives: Other: medical chart review; Other: questionnaire administration; Other: survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of standard pain management methods and outcomes in the hospice setting
Measured: date on study to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 22 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 A. Murphy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609297
- Sponsor's protocol ID
- VICC SUPP 0731
- Other IDs
- VU-VICC-SUPP-0731, VU-VICC-070605
- Status last verified
- Oct 2012
- First submitted
- 6 Feb 2008
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 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 Stage 2, Part A
- ClinicalTrials.gov ID
- NCT00609297
- Acronym / sponsor ID
- VICC SUPP 0731
- Conditions
- Pain, Solid Tumor
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Feb 2008 (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: Gathering information over time about cancer-related pain from patients in a hospice and their caregivers may help doctors learn more about pain control.
PURPOSE: This clinical trial is studying how well standard pain control works in hospice patients with cancer-related pain.
Detailed description
OBJECTIVES:
- To obtain prospective data describing standard pain management methods and outcomes in the hospice setting.
OUTLINE: Data regarding pain and pain management is obtained from three sources: the patient, the caregiver(s), and the medical records.
- Patient assessment*: At baseline, patients provide demographic data and complete the Pain Assessment Form verbally via interview. The form addresses average pain, worst pain, pain relief, hours in pain, pain-related distress, and barriers to pain control. Patients are asked to rate pain control. Patients also complete the Pain Communication Survey to assess how they communicate with health care providers about their pain. After the baseline assessment is completed, pain is assessed by the research nurse through home visits* 3 times weekly and telephone interviews twice weekly. During each visit or telephone contact, patients are interviewed to complete the Pain Assessment Form. Patients are followed until the time of death.
NOTE: *If a patient is not available for the scheduled home visit, the interview will take place over the phone; if a patient is hospitalized or transferred to the inpatient hospice facility, the patient interview will take place there.
- Primary caregiver assessment**: At baseline, primary caregivers complete a demographic survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain Management Scale (CSEPMS), the Caregiver Pain Management Questionnaire (CPMQ), and the Stressful Caregiver Adult Reactions to Experiences of Dying (SCARED). Caregivers are then interviewed by the study nurse using the Pain Assessment Form as a guideline. Follow-up data from caregivers is obtained through a daily diary, interviews, and structured surveys. Primary caregivers complete the Pain Assessment Form daily and are instructed to provide their assessment of the patient's pain. In addition, caregivers are interviewed daily by a study nurse, who reviews the daily Pain Assessment Form and obtains detailed information regarding the adequacy of patient pain control, side effects of medication, barriers to pain control, and caregiver concerns and burdens. Primary caregivers also complete CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4 as part of follow-up. Primary caregivers are contacted after the patient's death to assess pain control at the time of death.
- Secondary caregiver assessment: At baseline, secondary caregivers complete the same baseline evaluation as primary caregivers over the phone. They complete the Pain Assessment Form weekly and the CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4. Secondary caregivers also undergo a post-mortem interview based on the Pain Assessment Form.
- Chart review: Chart review is conducted by the research Nurse after a patient's death. Cancer and cancer-related treatment are obtained and documentation about pain management is recorded. From the time of study entry, all staff notes are reviewed to document: pain assessment, calls to physicians or other support personnel (including pharmacy calls), identified barriers to pain control, and treatment modifications (including medications to treat side effects).
NOTE: **Patients and primary caregivers are interviewed independently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | – | Other: medical chart review, Other: questionnaire administration, Other: survey administrationAlive Hospice Patients with Pain |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Alive hospice who have pain and their caregivers.
Key inclusion criteria (11 listed)
- Alive Hospice outpatient
- Diagnosis of carcinoma
- Pain requiring fixed dose opioids
- Age > 21 years
- Not pregnant or lactating
Key exclusion criteria (2 listed)
- Not specified
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 |
|---|---|---|
| medical chart reviewAlso: None specifiedThe Research Nurse will conduct a chart review after the patient's death. | Other | Supportive Care |
| questionnaire administrationAlso: None SpecifiedThe questionnaires will be completed at the end of week 1, week 2 and week 4. | Other | Supportive Care |
| survey administrationAlso: none specifiedGiven to patient and caregivers throughout the study | Other | Supportive Care |
Primary outcome
Description of standard pain management methods and outcomes in the hospice setting
Time frame: date on study to 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 24 Oct 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 A. 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 Pain and Solid Tumor, 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 11 inclusion and 2 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 24 Oct 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?
Description of standard pain management methods and outcomes in the hospice setting (time frame: date on study to 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 24 Oct 2012.