Improving Care After Chemotherapy (IMPACT)
|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
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Colorectal Cancer Breast Cancer||Other: Nursing Intervention||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Care After Chemotherapy|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||November 2014|
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
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944137
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Theresa McDonnell, ACNP-BC||Massachusetts General Hospital|