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Improving Care After Chemotherapy (IMPACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Theresa McDonnell, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01944137
First received: September 12, 2013
Last updated: April 8, 2015
Last verified: March 2015
History of Changes

September 12, 2013
April 8, 2015
September 2013
November 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01944137 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Improving Care After Chemotherapy
Improving Care After Chemotherapy
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.
  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Breast Cancer
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.
  • 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
    Intervention: Other: Nursing Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01944137
13-258
No
Not Provided
Not Provided
Theresa McDonnell, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Theresa McDonnell, ACNP-BC Massachusetts General Hospital
Massachusetts General Hospital
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP