Overview

This trial is active, not recruiting.

Conditions non-small cell lung cancer, colorectal cancer, breast cancer
Treatment nursing intervention
Sponsor Massachusetts General Hospital
Start date September 2013
End date November 2014
Trial size 120 participants
Trial identifier NCT01944137, 13-258

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
Participant will receive standard cancer care
(Experimental)
Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy
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.

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.
time frame: 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.
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Improving Care After Chemotherapy
Principal investigator Theresa McDonnell, ACNP-BC
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.