Recruitment

Recruitment Status
Completed
Estimated Enrollment
8

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
  • Breathlessness
  • Dyspnea
  • Lung Cancer
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The purpose of this single-group pilot study is to test the feasibility and acceptability of a cognitive-behavioral intervention for breathlessness in patients with lung cancer. Clinic staff and research assistants will recruit potential participants in the outpatient oncology department of the Mass...

The purpose of this single-group pilot study is to test the feasibility and acceptability of a cognitive-behavioral intervention for breathlessness in patients with lung cancer. Clinic staff and research assistants will recruit potential participants in the outpatient oncology department of the Massachusetts General Hospital. All participants will complete informed consent procedures prior to initiating the study. The Dana-Farber/Partners Institutional Review Board has approved the study methods. Before beginning the first intervention session, enrolled participants will complete questionnaires either on paper or online via a secure survey website. The questionnaire takes about 15 minutes to complete and asks about the experience of breathlessness, mood and anxiety symptoms, as well as general quality-of-life. Participants may refuse to answer any questions that they do not wish to answer. The study intervention involves two sessions with a nurse practitioner. Each session will take approximately 30-45 minutes to complete. The first session will be scheduled around another oncology appointment, such immediately before or after a clinic visit, or at the same time as a chemotherapy infusion. During this session, participants will learn about several breathing and relaxation exercises designed to relieve breathlessness. The nurse practitioner will also provide handouts with directions for these exercises, an audio recording of the relaxation techniques, and worksheets to encourage daily practice of these breathing and relaxation exercises at home. The second session, which will take place 1-4 weeks after the first session, may also be scheduled either before or after another oncology appointment. However, if this is not possible, the second session may be completed over the telephone. During this session, participants will meet with the same nurse practitioner to review the behavioral exercises and to address any difficulties the participants may have experienced in practicing the exercises. Within two weeks after the second intervention session, a research assistant will contact the participants either in person or over the telephone to complete the same questionnaires administered before the intervention. Participants may choose to complete the follow-up questionnaires on paper, over the telephone, or on a secure internet survey website. Also, within two weeks after the second intervention session, the research assistant will conduct a brief interview with the participants. Specifically, the research assistant will ask questions about participants' perceived satisfaction with the behavioral intervention and obtain feedback about how to improve the intervention. The interview will be audio-recorded and take approximately 15-20 minutes to complete. These recordings and transcripts will only be identified with a study number and stored electronically in a computer file that is protected with a password only accessible to study staff. After completing the interview, participants will be finished with the study.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Boston, Massachusetts, 02114
Boston, Massachusetts, 02114

Tracking Information

NCT #
NCT01937637
Collaborators
Not Provided
Investigators
  • Principal Investigator: Joseph Greer, Ph.D. Massachusetts General Hospital
  • Joseph Greer, Ph.D. Massachusetts General Hospital