CancerNCT00300001
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
An observational study of Cancer and Solid Tumor, run by Community Cancer Care at 3 sites in United States.
Trial summary
The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Malignancy
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent \& consent to use the Cancer Symptom Monitor -
Who cannot join
- Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Quality Oncology Care, Inc.
Indianapolis, Indiana, 46202
Dale E Theobald, PhD, MD
- Recruiting
Community Regional Cancer Center-Community Hospital North
Indianapolis, Indiana, 46256
Dale E Theobald, PhD, MD
- Recruiting
Morgan Hospital and Medical Center
Martinsville, Indiana, 46151
Dale E. Theobald, PhD, MD
About this study
The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.
Read the detailed description
Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive "standard care" without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, \& 12 months, for symptom levels and overall quality of life during the twelve-month study period.
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- Cancer, Symptom Management, Supportive Symptom Interventions, Symptom Severity, quality of life, Home-based symptom monitoring
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Community Cancer Care
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Dale E. Theobald, PhD, MD, Principal investigator, Community Cancer Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300001
- Sponsor's protocol ID
- 2005-0186
- Status last verified
- Aug 2006
- First submitted
- 3 Mar 2006
- Last updated
- 25 Aug 2006
- Results posted
- No
Publications
Berger AM, Portenoy RK, Weissman DE., Eds. Principles and Practice of Supportive Oncology, 2nd Ed.; Lippincott-Raven: Philadelphia, 2002.
Max MB, Portenoy RK, Laska EM, Eds. Oxford Textbook of Palliative Medicine, 2nd Ed.; Oxford Medical Publications: New York, 1998.
Cleeland CS, Reyes-Gibby CC. When is it justified to treat symptoms? Measuring symptom burden. Oncology (Williston Park). 2002 Sep;16(9 Suppl 10):64-70.
PubMed 12380956Chang VT, Ingham J. Symptom control. Cancer Invest. 2003;21(4):564-78. doi: 10.1081/cnv-120022376.
PubMed 14533447Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Ried LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom Management in Cancer: Pain, Depression, and Fatigue, July 15-17, 2002. J Natl Cancer Inst. 2003 Aug 6;95(15):1110-7. doi: 10.1093/jnci/djg014.
PubMed 12902440Oncology Nursing Society, Research Agenda, 2003-2205. Available at http://www.ons.org/images/PDFs/Research/2003Plan.pdf.
Passik SD, Dugan W, McDonald MV, Rosenfeld B, Theobald DE, Edgerton S. Oncologists' recognition of depression in their patients with cancer. J Clin Oncol. 1998 Apr;16(4):1594-600. doi: 10.1200/JCO.1998.16.4.1594.
PubMed 9552071McDonald MV, Passik SD, Dugan W, Rosenfeld B, Theobald DE, Edgerton S. Nurses' recognition of depression in their patients with cancer. Oncol Nurs Forum. 1999 Apr;26(3):593-9.
PubMed 10214600Abdullah M, Theobald DE, Butler D, Kroenke K, Perkins A, Edgerton S, Dugan WM Jr. Access to communication technologies in a sample of cancer patients: an urban and rural survey. BMC Cancer. 2005 Feb 17;5:18. doi: 10.1186/1471-2407-5-18.
PubMed 15717933Theobald DE, Butler D, Coburn J, et al. IVR-based cancer symptom assessment: Nurses' expectations and perceived barriers. (Abstract) Am Soc Clin Oncol, New Orleans, 2004.
Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
PubMed 15108222Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.
PubMed 11013380Schubert MM, Williams BE, Lloid ME, Donaldson G, Chapko MK. Clinical assessment scale for the rating of oral mucosal changes associated with bone marrow transplantation. Development of an oral mucositis index. Cancer. 1992 May 15;69(10):2469-77. doi: 10.1002/1097-0142(19920515)69:103.0.co;2-w.
PubMed 1568168Kreuger RA. Focus Groups: A practical guide for Applied Research. Sage Publications: Thousand Oakes, CA, 1994.
Munhall P. Nursing Research: A qualitative perspective, third edition. 2001.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
- ClinicalTrials.gov ID
- NCT00300001
- Acronym / sponsor ID
- 2005-0186
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- Cancer, Symptom Management, Supportive Symptom Interventions, Symptom Severity, quality of life, Home-based symptom monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Community Cancer CareUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Mar 2006
- First posted
- 7 Mar 2006 (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 primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.
Detailed description
Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive "standard care" without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, \& 12 months, for symptom levels and overall quality of life during the twelve-month study period.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent \& consent to use the Cancer Symptom Monitor -
Key exclusion criteria (1 listed)
- Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2006.
- BackgroundBerger AM, Portenoy RK, Weissman DE., Eds. Principles and Practice of Supportive Oncology, 2nd Ed.; Lippincott-Raven: Philadelphia, 2002.
- BackgroundMax MB, Portenoy RK, Laska EM, Eds. Oxford Textbook of Palliative Medicine, 2nd Ed.; Oxford Medical Publications: New York, 1998.
- Background: PubMed 12380956Cleeland CS, Reyes-Gibby CC. When is it justified to treat symptoms? Measuring symptom burden. Oncology (Williston Park). 2002 Sep;16(9 Suppl 10):64-70.
- Background: PubMed 14533447Chang VT, Ingham J. Symptom control. Cancer Invest. 2003;21(4):564-78. doi: 10.1081/cnv-120022376.
- Background: PubMed 12902440Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Ried LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom Management in Cancer: Pain, Depression, and Fatigue, July 15-17, 2002. J Natl Cancer Inst. 2003 Aug 6;95(15):1110-7. doi: 10.1093/jnci/djg014.
- BackgroundOncology Nursing Society, Research Agenda, 2003-2205. Available at http://www.ons.org/images/PDFs/Research/2003Plan.pdf.
- Background: PubMed 9552071Passik SD, Dugan W, McDonald MV, Rosenfeld B, Theobald DE, Edgerton S. Oncologists' recognition of depression in their patients with cancer. J Clin Oncol. 1998 Apr;16(4):1594-600. doi: 10.1200/JCO.1998.16.4.1594.
- Background: PubMed 10214600McDonald MV, Passik SD, Dugan W, Rosenfeld B, Theobald DE, Edgerton S. Nurses' recognition of depression in their patients with cancer. Oncol Nurs Forum. 1999 Apr;26(3):593-9.
- Background: PubMed 15717933Abdullah M, Theobald DE, Butler D, Kroenke K, Perkins A, Edgerton S, Dugan WM Jr. Access to communication technologies in a sample of cancer patients: an urban and rural survey. BMC Cancer. 2005 Feb 17;5:18. doi: 10.1186/1471-2407-5-18.
- BackgroundTheobald DE, Butler D, Coburn J, et al. IVR-based cancer symptom assessment: Nurses' expectations and perceived barriers. (Abstract) Am Soc Clin Oncol, New Orleans, 2004.
- Background: PubMed 15108222Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
- Background: PubMed 11013380Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Dale E. Theobald, PhD, MD principal investigator
Community Cancer Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by Community Cancer Care at 3 sites 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 1 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: status not confirmed, as of the sponsor's last update on 25 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dale E Theobald, PhD, MD (317-621-4325, dtheobald@ecommunity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300001, which also lists 17 linked publications.
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 25 Aug 2006.