Breast Cancer Clinical Trial
— IMPACTOfficial title:
Improving Care After Chemotherapy
NCT number | NCT01944137 |
Other study ID # | 13-258 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | February 2, 2017 |
Verified date | August 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 2, 2017 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline (i.e. first chemotherapy administration visit) in patient-reported symptoms as measured by the Memorial Symptom Assessment Scale-Short Form. | Eight symptom items assessing presence and level of distress per symptom over past week on a 5-point Likert type scale | At approximately 2-3 weeks and 4-6 weeks post-baseline | |
Secondary | Change from baseline (i.e. first chemotherapy administration visit) in patient-reported psychological distress as measured by the Patient Health Questionnaire-4. | 4-item screen of depression and anxiety symptoms | Approximately 2-3 weeks and 4-6 weeks post-baseline | |
Secondary | 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 | 13 items assess patient satisfaction with medical care on a 5-point Likert-type scale | Approximately 2-3 weeks and 4-6 weeks post-baseline | |
Secondary | Frequency of urgent outpatient Cancer Center visits, emergency department visits, and hospital admissions during six months post-baseline | Approximately six months post-baseline |
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