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Improving Care After Chemotherapy (IMPACT)

Primary Purpose

Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nursing Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring colonic neoplasms, Lung neoplasms, patient-centered nursing, breast neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Nursing Intervention

Arm Description

Participant will receive standard cancer care

Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy

Outcomes

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.
Eight symptom items assessing presence and level of distress per symptom over past week on a 5-point Likert type scale

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.
4-item screen of depression and anxiety symptoms
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
13 items assess patient satisfaction with medical care on a 5-point Likert-type scale
Frequency of urgent outpatient Cancer Center visits, emergency department visits, and hospital admissions during six months post-baseline

Full Information

First Posted
September 12, 2013
Last Updated
August 31, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01944137
Brief Title
Improving Care After Chemotherapy
Acronym
IMPACT
Official Title
Improving Care After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
Keywords
colonic neoplasms, Lung neoplasms, patient-centered nursing, breast neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participant will receive standard cancer care
Arm Title
Nursing Intervention
Arm Type
Experimental
Arm Description
Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy
Intervention Type
Other
Intervention Name(s)
Nursing Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline (i.e. first chemotherapy administration visit) in patient-reported symptoms as measured by the Memorial Symptom Assessment Scale-Short Form.
Description
Eight symptom items assessing presence and level of distress per symptom over past week on a 5-point Likert type scale
Time Frame
At approximately 2-3 weeks and 4-6 weeks post-baseline
Secondary Outcome Measure Information:
Title
Change from baseline (i.e. first chemotherapy administration visit) in patient-reported psychological distress as measured by the Patient Health Questionnaire-4.
Description
4-item screen of depression and anxiety symptoms
Time Frame
Approximately 2-3 weeks and 4-6 weeks post-baseline
Title
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
Description
13 items assess patient satisfaction with medical care on a 5-point Likert-type scale
Time Frame
Approximately 2-3 weeks and 4-6 weeks post-baseline
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa McDonnell, ACNP-BC
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Improving Care After Chemotherapy

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