Improving Care After Chemotherapy

NCT01944137 | Completed

• 1 other identifier: 13-258
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

colonic neoplasms; Lung neoplasms; patient-centered nursing; breast neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  At approximately 2-3 weeks and 4-6 weeks post-baseline

Secondary Outcomes (3)

• Change from baseline (i.e. first chemotherapy administration visit) in patient-reported psychological distress as measured by the Patient Health Questionnaire-4.

  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

  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

  Approximately six months post-baseline

Study Arms (2)

Standard Care

NO INTERVENTION

Participant will receive standard cancer care

Nursing Intervention

EXPERIMENTAL

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

Other: Nursing Intervention

Interventions

Nursing Intervention OTHER

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.

Nursing Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Already received 1 or more cycles of chemotherapy for the current regimen
• Unwilling or unable to participate in the study

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Breast Neoplasms; Colonic Neoplasms; Lung Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

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; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Theresa McDonnell, ACNP-BC

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: February 2, 2017
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)