Improving Care After Chemotherapy (IMPACT)
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ClinicalTrials.gov Identifier: NCT01944137 |
Recruitment Status
: Unknown
Verified March 2015 by Theresa McDonnell, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted
: September 17, 2013
Last Update Posted
: April 9, 2015
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Theresa McDonnell, Massachusetts General Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | September 12, 2013 | |||
First Posted Date ICMJE | September 17, 2013 | |||
Last Update Posted Date | April 9, 2015 | |||
Study Start Date ICMJE | September 2013 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline (i.e. first chemotherapy administration visit) in patient-reported symptoms as measured by the Memorial Symptom Assessment Scale-Short Form. [ Time Frame: At approximately 2-3 weeks and 4-6 weeks post-baseline ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01944137 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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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 | Improving Care After Chemotherapy | |||
Official Title ICMJE | Improving Care After Chemotherapy | |||
Brief Summary | The main purpose of this study is to examine changes in patient-reported symptoms during the first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care plus a proactive nursing intervention relative to patients who receive standard care alone. Interventions to improve symptom management and prevent urgent care needs in both the clinic and hospital for patients receiving chemotherapy with curative intent are needed to enhance the quality of cancer care. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Other: Nursing Intervention
Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy, in order to proactively monitor and address chemotherapy-related symptoms. |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01944137 | |||
Other Study ID Numbers ICMJE | 13-258 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Theresa McDonnell, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |