Improving Management of Breathlessness in Patients With Lung Cancer

NCT01937637 | Completed DMC

• 1 other identifier: 13-276
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Many individuals with lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer. In this study, the investigators plan on recruiting individuals with lung cancer to participate in a behavioral intervention to help relieve breathlessness. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained nurse practitioners in how to deliver the behavioral intervention. The nurse practitioners will meet with patients diagnosed with lung cancer during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. Specifically, the intervention includes education about the relationship between breathlessness and the stress response as well as teaches patients skills for breathing control and relaxation of the body. For this single-group pilot study, the investigators will ask participants to provide feedback about whether they found the intervention acceptable and effective. Participants will also complete questionnaires about their physical and psychological symptoms before and after the intervention in order to measure its effectiveness for treating breathlessness and any distress related to breathlessness. The data from this study will help inform improvements to the intervention in order to make it feasible and effective for treating breathlessness in patients with lung cancer.

Conditions

Breathlessness; Dyspnea; Lung Cancer

Keywords

Cognitive Behavioral Intervention for Breathlessness

Outcome Measures

Primary Outcomes (3)

• Feasibility and acceptability of a nurse practitioner-delivered dyspnea management intervention in patients with advanced lung cancer

  Feasibility and acceptability of the intervention will be determined via individual qualitative, exit interviews with participants. These interviews will assess the following: 1) satisfaction with the dyspnea intervention; 2) perceptions of potential problems with the approach, and 3) recommendations for improving the dyspnea intervention and delivery methods to enhance feasibility and acceptability.

  Post-intervention (within two weeks of completing the intervention)

• Effect of a nurse practitioner-delivered dyspnea management intervention on breathlessness in patients with advanced lung cancer

  Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI): For the primary outcome measure, we will also use the BDI-TDI to assess change in dyspnea from baseline to post-intervention. The scale is a valid and reliable interviewer-administered measure that consists of three sub-categories which each assess breathlessness on a 5-point grading system. We administer only the "magnitude of task" subscale, which assesses breathlessness based on the intensity of tasks that elicit shortness of breath.

  1) Pre-intervention (after enrollment); and 2) Post-intervention (within two weeks of completing the intervention)

• Effect of a nurse practitioner-delivered dyspnea management intervention on breathlessness in patients with advanced lung cancer

  Modified Medical Research Council Dyspnea Scale (MMRCDS): For the primary outcome measure, we also will use the MMRCDS to assess change in dyspnea from baseline to post-intervention. The scale is a validated self-report measure with a 5-point grading system to evaluate breathlessness.

  1) Pre-intervention (after enrollment); and 2) Post-intervention (within two weeks of completing the intervention)

Secondary Outcomes (2)

• Effect of a nurse practitioner-delivered dyspnea management intervention on quality of life in patients with advanced lung cancer

  1) Pre-intervention (after enrollment); and 2) Post-intervention (within two weeks of completing the intervention)

• Effect of a nurse practitioner-delivered dyspnea management intervention on mood symptoms in patients with advanced lung cancer

  1) Pre-intervention (after enrollment); and 2) Post-intervention (within two weeks of completing the intervention)

Study Arms (1)

Behavioral Intervention for Dyspnea

OTHER

In the first intervention session, enrolled participants will learn breathing and relaxation exercises designed to relieve breathlessness. The nurse practitioner will also provide handouts with directions for these exercises, an audio-recording with the relaxation exercises, and worksheets for daily home practice. During the second session, participants will again meet with the nurse practitioner to review the study exercises and to address any difficulties participants may have experienced in practicing the skills. All participants will complete questionnaires before and after the study intervention as well as a brief follow-up interview with the research assistant to obtain feedback about ways to improve the intervention to relieve breathlessness in patients with lung cancer.

Behavioral: Cognitive Behavioral Intervention for Breathlessness

Interventions

Cognitive Behavioral Intervention for Breathlessness BEHAVIORAL

Cognitive behavioral intervention for breathlessness, delivered by nurse practitioners during outpatient oncology appointments, in up to 8 patients with advanced lung cancer.

Also known as: Dyspnea Intervention

Behavioral Intervention for Dyspnea

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of stage III and IV non-small cell lung cancer (NSCLC) or extensive stage small-cell lung cancer (SCLC)
• Must be an adult (age greater than 18 years)
• Must receive cancer treatment (radiation or chemotherapy) within the ambulatory clinics of the Massachusetts General Hospital Cancer
• Must have an Eastern Cooperative Oncology Performance Status ranging from 0 (asymptomatic) to 2 (symptomatic but in bed less than 50% of time)
• Must have moderate breathlessness (i.e., a score of 2 or greater) on the Modified Medical Research Council Dyspnea Scale

You may not qualify if:

• Any untreated major mental illness or neuropsychiatric deficit prohibiting informed consent and/or ability to complete study procedures.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dyspnea; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Study Officials

• Joseph Greer, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 9, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

US (1)