Improving Care After Chemotherapy (IMPACT)

Tracking Information
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; (submitted: September 12, 2013)	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; (submitted: September 12, 2013)	Change from baseline (i.e. first chemotherapy administration visit) in patient-reported psychological distress as measured by the Patient Health Questionnaire-4. [ Time Frame: Approximately 2-3 weeks and 4-6 weeks post-baseline ]; Change from baseline (i.e. first chemotherapy administration visit) in patient-reported satisfaction with oncology care as measured by the Family Caregiver Satisfaction-patient scale [ Time Frame: Approximately 2-3 weeks and 4-6 weeks post-baseline ]; Frequency of urgent outpatient Cancer Center visits, emergency department visits, and hospital admissions during six months post-baseline [ Time Frame: Approximately six months post-baseline ]
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	Participants with NSCLC, CRC or breast cancer undergoing neoadjuvant or adjuvant chemotherapy will be asked to fill out self-report questionnaires at their first chemotherapy administration visit, in order to measure patient-reported symptoms, psychological distress, and satisfaction with oncology care.; Participants will then be randomized into one of the two study groups: standard care with proactive phone calls from nurse practitioners or standard care alone.; Participants assigned to the standard care group will be treated by their care team as would any other cancer patient.; Participants assigned to the intervention group will receive four proactive phone calls from nurse practitioners designed to discuss symptom burden and management. Proactive phone calls will occur 2-4 days after chemotherapy administration and 5-7 days after chemotherapy administration, during cycles 1 and 2.; Participants will be asked to fill out the same set of questionnaires during their second and third chemotherapy administration visits, to assess patient-reported symptoms, psychological distress, and satisfaction with oncology care.; Medical records will be reviewed at 24-weeks following the first chemotherapy administration visit, to evaluate frequency of urgent outpatient cancer center visits, emergency department visits, and hospital admissions that occurred during the study period.
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
Condition ICMJE	Non-small Cell Lung Cancer; Colorectal Cancer; Breast Cancer
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.
Study Arms	No Intervention: Standard Care Participant will receive standard cancer care; Experimental: Nursing Intervention Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy Intervention: Other: Nursing Intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: September 12, 2013)	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: Adult (age 18 or older); Newly diagnosed stage I-III colorectal cancer, non-small-cell lung cancer, or breast cancer; Scheduled to receive neoadjuvant chemotherapy (i.e. pre-surgical cancer-directed therapy with curative intent) or adjuvant chemotherapy (i.e. post-surgical cancer-directed therapy with curative intent); Able to respond to questions in English Exclusion Criteria: Already received 1 or more cycles of chemotherapy for the current regimen; Unwilling or unable to participate in the study
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Theresa McDonnell, ACNP-BC Massachusetts General Hospital
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