Improving Care After Chemotherapy (IMPACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Theresa McDonnell, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01944137
First received: September 12, 2013
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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) and colorectal cancer (CRC), 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.


Condition Intervention
Non-small Cell Lung Cancer
Colorectal Cancer
Other: Nursing Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Care After Chemotherapy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
  • Participants with NSCLC or CRC 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (age 18 or older)
  • Newly diagnosed stage I-III colorectal cancer or non-small-cell lung 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944137

Contacts
Contact: Theresa McDonnell, DNP, APRN-BC 617-726-2602 tmcdonnell@partners.org
Contact: Caitlin E McCarty, BA cemccarty@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Theresa McDonnell, ACN-BC         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Theresa McDonnell, ACNP-BC Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Theresa McDonnell, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01944137     History of Changes
Other Study ID Numbers: 13-258
Study First Received: September 12, 2013
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
colonic neoplasms
Lung neoplasms
patient-centered nursing

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014