CarcinomaNCT00006253
Pain and Fatigue Study
A study testing Nurse and Non-nurse coach in people with Carcinoma, run by Michigan State University at 1 site in United States.
Trial summary
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- Nurse and Non-nurse coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2006
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- solid tumor cancer diagnosis
- receiving chemotherapy treatment
- advanced cancer
- family caregiver
Who cannot join
- Emotional or psychology disorder for which patient is receiving treatment
- does not speak English
- does not have access to a telephone
- difficulty hearing on the telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Family Home Care for Cancer - A Community-Based Model
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care.
When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following:
- The primary outcome--total number of symptoms reported;
- The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and
- Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.
Read the detailed description
GOAL: The primary goal of this research is to test a symptom management intervention, delivered by nurses with special training, using a stepped-care approach targeted toward pain and fatigue, followed by fifteen other prevalent cancer symptoms. Second goals are to improve physical and social functioning, lower emotional distress, and improve communication with family caregiver in symptom management, and assist them to reduce their levels of depression and burden. This research is funded through a grant from the National Cancer Institutes, and builds upon the Family Care Research Team's program of supportive cancer-care research.
OUTCOMES: This study tests a stepped-approach intervention to determine if it improves symptom outcomes, especially pain and fatigue. Secondary outcomes addressed by the intervention are physical role impact, social functioning, and emotional distress. These outcomes can have significant impact on patients and family caregivers' well-being as patients undergo chemotherapy. The shorter, more intense intervention corresponds to changes int he clinical management of cancer patient with more intense, shorter chemotherapy treatments; therefore, this intervention will be more easily translatable to the clinical setting.
- Conditions
- Carcinoma
- Being tested
- Nurse, Non-nurse coach
- Keywords
- symptom management, cancer, chemotherapy treatment, Behavioral Research, Physiological Effects of Drugs, Clinical Trial, Phase II
- Medical subject headings
- Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NurseBehavioural
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
Non-nurse coachBehavioural
Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management
| Study group | Role | What they receive |
|---|---|---|
| Nurse | Experimental | Receives symptom management assistance from an oncology nurse via the telephone Receives: Behavioral: Nurse |
| Non-nurse coach | Experimental | Receives symptom management assistance from a non-nurse coach via telephone Receives: Behavioral: Non-nurse coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patient outcome
Lower reported severity of symptoms
Secondary outcomes (1)
Secondary Patient Outcomes
Reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care and communication, and satisfaction with provider care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2004 (estimated)
- Study startMar 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Given, Michigan State University
- Investigators
- Barbara A. Given, PhD, RN, FAAN, Study chair, Breslin Cancer Center at Ingham Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006253
- Sponsor's protocol ID
- R01CA079280
- Status last verified
- Dec 2011
- First submitted
- 11 Sep 2000
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Home Care for Cancer - A Community-Based Model
- ClinicalTrials.gov ID
- NCT00006253
- Acronym / sponsor ID
- R01CA079280
- Conditions
- Carcinoma
- Keywords
- symptom management, cancer, chemotherapy treatment, Behavioral Research, Physiological Effects of Drugs, Clinical Trial, Phase II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Mar 2004 (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.
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care.
When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following:
- The primary outcome--total number of symptoms reported;
- The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and
- Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.
Detailed description
GOAL: The primary goal of this research is to test a symptom management intervention, delivered by nurses with special training, using a stepped-care approach targeted toward pain and fatigue, followed by fifteen other prevalent cancer symptoms. Second goals are to improve physical and social functioning, lower emotional distress, and improve communication with family caregiver in symptom management, and assist them to reduce their levels of depression and burden. This research is funded through a grant from the National Cancer Institutes, and builds upon the Family Care Research Team's program of supportive cancer-care research.
OUTCOMES: This study tests a stepped-approach intervention to determine if it improves symptom outcomes, especially pain and fatigue. Secondary outcomes addressed by the intervention are physical role impact, social functioning, and emotional distress. These outcomes can have significant impact on patients and family caregivers' well-being as patients undergo chemotherapy. The shorter, more intense intervention corresponds to changes int he clinical management of cancer patient with more intense, shorter chemotherapy treatments; therefore, this intervention will be more easily translatable to the clinical setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse | Experimental | Behavioral: NurseReceives symptom management assistance from an oncology nurse via the telephone |
| Non-nurse coach | Experimental | Behavioral: Non-nurse coachReceives symptom management assistance from a non-nurse coach via telephone |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years of age or older
- solid tumor cancer diagnosis
- receiving chemotherapy treatment
- advanced cancer
- family caregiver
Key exclusion criteria (4 listed)
- Emotional or psychology disorder for which patient is receiving treatment
- does not speak English
- does not have access to a telephone
- difficulty hearing on the telephone
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 |
|---|---|---|
| NurseReceives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management | Behavioural | Nurse |
| Non-nurse coachReceives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management | Behavioural | Non-nurse coach |
Primary outcome
Primary patient outcome
Lower reported severity of symptoms
1 secondary outcome
Secondary Patient Outcomes
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 Dec 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.
Barbara A. Given, PhD, RN, FAAN study chair
Breslin Cancer Center at Ingham Regional 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 Nurse and Non-nurse coach in people with Carcinoma, run by Michigan State University 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 5 inclusion and 4 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 Dec 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?
Primary patient outcome. 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 Dec 2011.