Improving Care After Chemotherapy (IMPACT)

August 31, 2020 updated by: Lara Traeger, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-item screen of depression and anxiety symptoms
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
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
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
Approximately six months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Theresa McDonnell, ACNP-BC, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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