Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 22, 2010 | ||||
| Last Updated Date | November 11, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01228461 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk. The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following: Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors. Hypotheses:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum samples for IL-1ra and CRP |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adolescents and young adult survivors of Hodgkin Lymphoma |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | AYA with Fatigue and Hodgkin Lymphoma | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | February 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 39 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01228461 | ||||
| Other Study ID Numbers ICMJE | 091550 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pinki K. Prasad, Vanderbilt University Medical Center | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Vanderbilt University | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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