Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Inclusion Criteria:

- English-speaking, age ≥ 18 years old

- A diagnosis of cancer with no restrictions placed on type of cancer or stage.
Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis.
Participating institution's testing is sufficient for other study sites.

- Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one
month prior to study initiation (patients on continued hormone treatment or
maintenance targeted therapies will not be excluded).

- A score >7 on our primary outcome (the Insomnia Severity Index)

- A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual
of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to
this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity
characterized by difficulty initiating sleep, maintaining sleep, or early morning
awakenings that cause significant distress or impairment in daytime functioning and
occur at least three nights per week for at least three months despite adequate
opportunity for sleep.

- Patients using psychotropic medication (e.g. antidepressants) will remain eligible for
study participation provided that the dose was not recently altered (stable over the
previous 6-weeks).

- Patients using hypnotics or sedatives will be eligible for study participation.
Considering the high use of benzodiazepines within the oncology population, past
research has included participants who met diagnostic criteria for insomnia, despite
the use of benzodiazepines, and included monitoring of medication use.

Exclusion Criteria:

- Another sleep disorder, other than sleep apnea, that is not adequately treated.

- Previous experience with CBT or acupuncture to treat insomnia

- Currently participating in another acupuncture trial or a trial to treat insomnia

- The presence of another Axis I disorder not in remission

- Employment in a job requiring shift work that would impair the ability to establish a
regular sleep schedule

- Patients who are currently taking oral (not including oral sprays/inhalers) or
intravenous corticosteroids as part of treatment for cancer or any other condition
will be excluded because of the potential of these drugs to induce insomnia