Developing and Testing of Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia

Developing and Testing of Culturally Appropriate Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia

This study focuses on improving insomnia among Hispanic cancer survivors. The three goals are to (1) culturally adapt Body-Mind Training and Cognitive Behavioral Therapy for Insomnia (CBT-I) with input from Hispanic cancer survivors, (2) determine whether the two programs are feasible and acceptable, and (3) explore whether they improve insomnia.

This study focuses on improving insomnia among Hispanic cancer survivors by adapting and testing two culturally appropriate sleep programs. First, up to 32 Hispanic cancer survivors will participate in four focus groups, with 6-8 participants per group, to provide feedback to help culturally adapt a Body-Mind Training (BMT) program and Cognitive Behavioral Therapy for Insomnia (CBT-I) in both English and Spanish. Eight of these participants will also complete individual interviews to provide additional feedback on the adapted programs. Second, 58 Hispanic cancer survivors with insomnia will participate in a randomized pilot study comparing BMT and CBT-I to determine whether the programs are feasible, acceptable, and practical for participants to complete. Third, the study will explore whether BMT and CBT-I improve insomnia, using both participant-reported insomnia symptoms and objective sleep measures collected with a wrist-worn activity monitor. Sleep will be assessed before the program, shortly after it ends, and three months later. The findings will help inform the design of a larger study comparing these approaches for treating insomnia among Hispanic cancer survivors.

Aim 1 (Cultural Adaptation):

Inclusion Criteria:

• Be 18 years of age or older
• Be at least 18 years old when received their cancer diagnosis
• Self-identify as Hispanic and/or Latino(a)
• Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy
• Completion of primary cancer treatment in the past 3 months - 5 years (may be on hormonal therapy and/or immunotherapy or other long-term therapies)
• Have sleep disturbance (indicated by a response of 3 or more on the MDASI sleep question by using an 11-point scale anchored by 0 [no sleep disturbance] and 10 [worst possible sleep disturbance]
• Be able to read and understand English and/or Spanish

Exclusion Criteria:

• Inability to speak and read English or Spanish proficiently
• Life expectancy <12 months

Aims 2-3 (RCT):

Inclusion Criteria:

• Be 18 years of age or older
• Self-identify as Hispanic and/or Latino(a)
• Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy
• Completion of primary cancer treatment in the past 3 months - 5years (may be on hormonal therapy and/or immunotherapy or other long-term therapies) Report sleep difficulties ≥3 times per week for ≥3 months consistentwith DSM-5 insomnia criteria4,
• Must have a score of ≥10 on the Insomnia Severity Index
• Must have a personal mobile device (i.e., mobile smart phone, laptop, desktop computer, tablet) with active internet
• Be able to read and understand English and/or Spanish
• Physically Inactive (<150 minutes of vigorous exercise/week within the past 3 months)

Exclusion Criteria:

• Current or last year practice of TCQ or similar practices;
• Current or past CBT-I treatment,
• Shift worker,
• Life expectancy <12 months,
• Health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems.
• Participants with a history of diagnosed sleep apnea or restless leg syndrome (RLS) will be excluded from the study, as both increase the risk for insomnia. All other participants will complete the STOP-Bang Sleep Apnea Screening Tool and a single RLS screening question during screening, as both are underdiagnosed in Hispanics. Those scoring ≥ 5 on the STOP-Bang, indicating high risk for moderate-to-severe sleep apnea, or who respond with 'Yes' on the RLS risk tool, will also be excluded and referred to a sleep medicine specialist for evaluation.