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

N/ANot Yet RecruitingNCT07800715

Rutgers, The State University of New Jersey58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Insomnia

Interventions

Body Mind TrainingBEHAVIORAL

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.

Cognitive Behavioral Therapy - InsomniaBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Recruitment Rate

We hypothesize that at least 50% of eligible individuals approached for the study will enroll.

Time frame: 1-2 weeks post-intervention

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.

Time frame: 1-2 weeks post-intervention

Actigraphy adherence rate

We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data

Time frame: baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Physical activity and sleep logs adherence rate

we hypothesize that )≥70% of participants will complete ≥75% of activity \& sleep logs.

Time frame: baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Acceptability

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

Time frame: 1-2 weeks post-intervention

Central Contacts

Evelyn Arana, DrPH

CONTACT

9086420861 earana@cinj.rutgers.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

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).

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

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

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Quality of Life (QOL)

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Anxiety and Depressive Symptoms

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Perceived Stress

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Fatigue

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Comorbidities

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.

Time frame: Baseline

Acculturation

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.

Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy

Actigraphy will measure the number of minutes of actual sleep.

Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)

Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy

Actigraphy will measure the percent of time actually slept compared to intended time sleeping.

Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)

Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy

Actigraphy will measure the minutes it takes for the participant to fall asleep.

Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)

Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy

Actigraphy will measure total minutes of wake time after sleep onset.

Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)

Perceived exertion

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.

Time frame: Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.

Treatment Credibility and Expectancy

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.

Time frame: During the first week of the intervention