About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to speak and read English or Spanish proficiently
Life expectancy <12 months
Be 18 years of age or older
Self-identify as Hispanic and/or Latino(a)
Trial design
Parallel
Treatments tested in this trial
Body Mind Training
BehavioralBody-Mind Training (BMT): A 12-week, group-based program delivered by live videoconference twice per week for 60 minutes. Each session includes a warm-up, gentle body movements combined with meditation, breathing techniques, and relaxation exercises. Movements can be completed while seated or standing to support participant safety and different physical abilities. Participants will also receive instructional videos and a manual to support home practice and will be encouraged to practice for at least 30 minutes, three days per week. The final four weeks of the program will emphasize skill consolidation and continued practice.
Cognitive Behavioral Therapy - Insomnia
BehavioralCognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered by live videoconference once per week for 60 minutes by a licensed bilingual psychologist experienced in CBT-I. Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention. Participants will be encouraged to practice the skills learned during sessions for at least 30 minutes per day, three days per week.
Treatment groups
Trial outcomes
Primary outcomes
Insomnia Severity Index
Insomnia will be assessed with the Insomnia Severity Index (ISI). A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
Recruitment Rate
We hypothesize that at least 50% of eligible individuals approached for the study will enroll.
Follow-up retention rate
We hypothesize that ≥80% of participants will complete the 1-week post-intervention assessment and ≥70% will complete the 3-month post-intervention assessment.
Actigraphy adherence rate
We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data
Secondary outcomes
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used, validated 19-item self-report measure of sleep quality over the past month. It yields a global score ranging from 0-21, with higher scores indicating poorer sleep quality and scores \>5 indicating clinically significant sleep disturbance. The PSQI has demonstrated good internal consistency (Cronbach's α = 0.83), test-retest reliability, and construct validity.
Sleep self-efficacy
Sleep self-efficacy will be measured with the sleep self-efficacy scale(SES). The SES is a 9-item self-report measure that assesses anindividual's confidence in their ability to achieve and maintain healthysleep. Items are rated on a 5-point Likert scale, with higher scoresindicating greater sleep self-efficacy.106 The SES has demonstratedexcellent internal consistency (Cronbach's α ≈ 0.90).
Mindfulness
Mindfulness will be measured with the Mindful Attention Awareness Scale (MAAS), a 15-item self-report measure that assesses dispositional mindfulness, specifically an individual's awareness of and attention to present-moment experiences. Items are rated on a 6-point Likert scale, with higher scores indicating greater mindfulness. The MAAS has demonstrated excellent internal consistency (Cronbach's α =0.80-0.90) and strong construct validity and is available in both English and Spanish
Physical Activity Level
Differences in physical activity outside theintervention will be assessed with the Godin-Shephard Leisure-TimePhysical Activity Questionnaire. This questionnaire is available andvalidated in English and Spanish.
Locations
Sponsors and contacts
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