Clinical trial NCT01944137: Improving Care After Chemotherapy
Official title: Improving Care After Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Colorectal Cancer
Breast Cancer
Keywords: colonic neoplasms
Lung neoplasms
patient-centered nursing
breast neoplasms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline (i.e. first chemotherapy administration visit) in patient-reported symptoms as measured by the Memorial Symptom Assessment Scale-Short Form.
timeFrame: At approximately 2-3 weeks and 4-6 weeks post-baseline
Secondary outcomes:
measure: Change from baseline (i.e. first chemotherapy administration visit) in patient-reported psychological distress as measured by the Patient Health Questionnaire-4.
timeFrame: Approximately 2-3 weeks and 4-6 weeks post-baseline
measure: 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
timeFrame: Approximately 2-3 weeks and 4-6 weeks post-baseline
measure: Frequency of urgent outpatient Cancer Center visits, emergency department visits, and hospital admissions during six months post-baseline
timeFrame: Approximately six months post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Theresa McDonnell, ACNP-BC
role: PRINCIPAL_INVESTIGATOR
References: