Improving Management of Breathlessness in Patients With Lung Cancer

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 Criteria:

- 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

Exclusion Criteria:

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