Cancers, PainNCT00012896
Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines
A study testing Telephone Care + Educational (AV Materials) in people with Cancers, Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancers, Pain
- What is being tested?
- Telephone Care + Educational (AV Materials)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a medical diagnosis of cancer, be experiencing pain as a result of their cancer or cancer treatment, be receiving treatment on an out-patient basis whereas they are taking their own medications, have a life expectancy of at least 6 months, have access to a telephone, are able to read and speak English, and do not have a drug abuse history.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.
Read the detailed description
Background:
Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.
Objectives:
The primary objective of this study is to determine the effects of two nursing interventions on the improvement of pain management (PM), functional status (FS) and quality of life (QOL) in veterans receiving cancer care in VA ambulatory care clinics. The two interventions will utilize selected cancer pain management strategies developed as Clinical Practice Guidelines by the Agency for Health Care Policy and Research (AHCPR). This study will test the hypothesis that those veterans in the intervention arms will have lower pain intensity scores, greater pain relief and satisfaction with PM, and will have higher QOL and FS scores specifically in the areas of physical and social functioning. A secondary aim is to measure the extent that cancer PM is affected by the intervening variables of age, affect, attitudinal barriers, veteran culture, type/stage of disease, and type of cancer treatment.
Methods:
The design of this randomized trial has one between-subjects factor, GROUP, with three levels (usual care, structured education, individualized coaching), and one within-subjects factor, TIME, with two measures, pre-test and post-test. Patients with cancer pain (n=320) are randomly assigned to one of three groups after stratifications to control for the confounding variables of pain intensity and effects of cancer treatment. Those in the structured education arm view a video on cancer pain management and receive the AHCPR patient pamphlet on cancer pain management. Those subjects in the individualized coaching arm receive the same structured education as above, but also partake in four telephone coaching sessions focusing on the individual's specific pain management problems. The primary outcome variables measured after 12 weeks are: satisfaction with pain management, quality of life and functional status.
Status:
The project is in the final phase of data analysis and writing the final report. A total of 322 subjects were recruited: 289 eligible patients completed the Pre-test and 227 completed the Post-Test. Two papers are approximately 75% written. The main study paper is in the planning stage, to be completed after the final report is submitted.
- Conditions
- Cancers, Pain
- Being tested
- Telephone Care + Educational (AV Materials)
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Care + Educational (AV Materials)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Telephone Care + Educational (AV Materials) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancers, 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marilyn K. Douglas, DNSc RN FAAN, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012896
- Sponsor's protocol ID
- NRI 97-026
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines
- ClinicalTrials.gov ID
- NCT00012896
- Acronym / sponsor ID
- NRI 97-026
- Conditions
- Cancers, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2004 (actual)
- First posted
- 16 Mar 2001 (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.
Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.
Detailed description
Background:
Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge, effective cancer management is infrequently achieved. While this problem is multi-factorial, the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions.
Objectives:
The primary objective of this study is to determine the effects of two nursing interventions on the improvement of pain management (PM), functional status (FS) and quality of life (QOL) in veterans receiving cancer care in VA ambulatory care clinics. The two interventions will utilize selected cancer pain management strategies developed as Clinical Practice Guidelines by the Agency for Health Care Policy and Research (AHCPR). This study will test the hypothesis that those veterans in the intervention arms will have lower pain intensity scores, greater pain relief and satisfaction with PM, and will have higher QOL and FS scores specifically in the areas of physical and social functioning. A secondary aim is to measure the extent that cancer PM is affected by the intervening variables of age, affect, attitudinal barriers, veteran culture, type/stage of disease, and type of cancer treatment.
Methods:
The design of this randomized trial has one between-subjects factor, GROUP, with three levels (usual care, structured education, individualized coaching), and one within-subjects factor, TIME, with two measures, pre-test and post-test. Patients with cancer pain (n=320) are randomly assigned to one of three groups after stratifications to control for the confounding variables of pain intensity and effects of cancer treatment. Those in the structured education arm view a video on cancer pain management and receive the AHCPR patient pamphlet on cancer pain management. Those subjects in the individualized coaching arm receive the same structured education as above, but also partake in four telephone coaching sessions focusing on the individual's specific pain management problems. The primary outcome variables measured after 12 weeks are: satisfaction with pain management, quality of life and functional status.
Status:
The project is in the final phase of data analysis and writing the final report. A total of 322 subjects were recruited: 289 eligible patients completed the Pre-test and 227 completed the Post-Test. Two papers are approximately 75% written. The main study paper is in the planning stage, to be completed after the final report is submitted.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Telephone Care + Educational (AV Materials) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have a medical diagnosis of cancer, be experiencing pain as a result of their cancer or cancer treatment, be receiving treatment on an out-patient basis whereas they are taking their own medications, have a life expectancy of at least 6 months, have access to a telephone, are able to read and speak English, and do not have a drug abuse history.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telephone Care + Educational (AV Materials) | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 Apr 2015.
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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.
Marilyn K. Douglas, DNSc RN FAAN principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Care + Educational (AV Materials) in people with Cancers, Pain, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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.
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 Apr 2015.