Insomnia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBody Mind Training
Body-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.
BEHAVIORALCognitive Behavioral Therapy - Insomnia
Cognitive 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | 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 | 1-2 weeks post-intervention | We hypothesize that at least 50% of eligible individuals approached for the study will enroll. |
| Follow-up retention rate | 1-2 weeks post-intervention | 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 | baseline, 1-2 weeks post-intervention, and 3 months post-intervention | We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data |
| Physical activity and sleep logs adherence rate | baseline, 1-2 weeks post-intervention, and 3 months post-intervention | we hypothesize that )≥70% of participants will complete ≥75% of activity \& sleep logs. |
| Acceptability | 1-2 weeks post-intervention | Acceptability will be assessed using the Treatment Perceptions Questionnaire (TPS). Participants will rate the comprehensibility of components of the culturally appropriate interventions, as well as their length, intensity, and overall suitability for reducing sleep-quality impairment. The TPQ is available in Spanish and English. We hypothesize that ≥80% of participants will find the intervention was acceptable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | 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 | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | 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 | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | 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 | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | 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. |
| Quality of Life (QOL) | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | Quality of Life (QOL) will be assessed via the Functional Outcomes for Cancer Therapy - General (FACT-G). This measure consists of 27 items designed to measure four domains of quality of life in cancer patients: physical, social, emotional, and functional well-being. Coefficients of reliability and validity are uniformly high. The scale's ability to discriminate among patients based on disease stage, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. The FACT-G is available and validated in English and Spanish. |
| Anxiety and Depressive Symptoms | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | Anxiety and depression will be measured with the Patient Health Questionnaire-4 (PHQ-4), a 4-item self-report measure that assesses symptoms of anxiety and depression over the past two weeks. It combines the 2-item Generalized Anxiety Disorder scale (GAD-2) and the 2-item Patient Health Questionnaire (PHQ-2), with higher scores indicating greater psychological distress. The PHQ-4 has demonstrated good internal consistency (Cronbach's α ≈ 0.81) and strong validity and is available in both English and Spanish. |
| Perceived Stress | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | Perceived stress will be measured with the Perceived Stress Scale (PSS-10), a 10-item self-report measure that assesses the degree to which individuals perceive their lives as stressful during the past month. Items are rated on a 5-point Likert scale, with higher scores indicating greater perceived stress. The PSS-10 has demonstrated good internal consistency (Cronbach's α ≈ 0.78-0.91), strong construct validity, and is available in both English and Spanish. |
| Fatigue | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | Fatigue will be assessed with the Functional Assessment of Chronic Illness - Fatigue (FACIT-F) Scale.120 This scale is frequently used with cancer survivors because it has established minimally important differences. This 13-item scale assesses the level of fatigue during usual activities over the past 7 days, with higher scores indicating less fatigue (score range=0-52; Cronbach's alpha=0.86). The FACIT-F is available in English and Spanish and validated in Spanish-speaking populations. |
| Comorbidities | Baseline | Comorbidities will be assessed with the Charlson Comorbidity Index. It is a weighted index that considers both the number and the seriousness of comorbid diseases. It consists of 19 items, each with an assigned weight from 1 to 6 according to the relative risk of dying within a year. In general, the absence of comorbidity is considered: 0-1 points; low comorbidity: 2 points; and high comorbidity:≥3 points. |
| Acculturation | Baseline, 1-2 weeks post-intervention, and 3 months post-intervention | Acculturation will be measured with the Short Acculturation Scale for Hispanics (SASH). The 12-item scale (explaining 67.6% of the variance for Hispanics) correlates highly with the following validation criteria: respondents' generation, length of residence in the U.S., age at arrival, ethnic self-identification, and an acculturation index. The SASH is available and validated in English and Spanish. |
| Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy | 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention) | Actigraphy will measure the number of minutes of actual sleep. |
| Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy | 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention) | Actigraphy will measure the percent of time actually slept compared to intended time sleeping. |
| Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy | 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention) | Actigraphy will measure the minutes it takes for the participant to fall asleep. |
| Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy | 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention) | Actigraphy will measure total minutes of wake time after sleep onset. |
| Perceived exertion | Within 24 hours after each BMT session, up to 24 sessions over 12 weeks. | Perceived exertion will be measured after each BMT session, with the classic Borg Rating of Perceived Exertion (RPE) scale, which is a 15-point scale (ranging from 6 to 20). It has been extensively tested and validated against physiological markers. This will be collected to ensure that the BMT intervention is perceived as being of mild to moderate intensity. |
| Treatment Credibility and Expectancy | During the first week of the intervention | Credibility/Expectancy Questionnaire (CEQ). The CEQ is a brief 6-item self-report measure assessing participants' perceived credibility of an intervention and expectations for improvement. It has demonstrated good internal consistency, with Cronbach's α generally ranging from 0.79-0.90 for credibility and 0.81-0.86 for expectancy, as well as good test-retest reliability. |
Contacts
CONTACTEvelyn Arana, DrPH
PRINCIPAL_INVESTIGATOREvelyn Arana, DrPH
Rutgers Cancer Institute
Outcome results
None listed