Developing and Testing of Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
28 agosto 2026 aggiornato da: Evelyn Arana, DrPH, Rutgers, The State University of New Jersey
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
58
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Evelyn Arana, DrPH
- Numero di telefono: 9086420861
- Email: earana@cinj.rutgers.edu
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Body Mind Training
Body-Mind Training: A 12-week, group-based program delivered virtually twice per week.
Sessions combine gentle body movements, breathing exercises, meditation, and relaxation techniques designed to support sleep and overall well-being.
Participants are also encouraged to practice at home between sessions.
|
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.
|
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Sperimentale: Cognitive Behavioral Therapy - Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered virtually once per week.
Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention.
Participants are encouraged to practice the skills between sessions.
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Insomnia Severity Index
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Recruitment Rate
Lasso di tempo: 1-2 weeks post-intervention
|
We hypothesize that at least 50% of eligible individuals approached for the study will enroll.
|
1-2 weeks post-intervention
|
|
Follow-up retention rate
Lasso di tempo: 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.
|
1-2 weeks post-intervention
|
|
Actigraphy adherence rate
Lasso di tempo: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data
|
baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Physical activity and sleep logs adherence rate
Lasso di tempo: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
we hypothesize that )≥70% of participants will complete ≥75% of activity & sleep logs.
|
baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Acceptability
Lasso di tempo: 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
|
1-2 weeks post-intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Sleep self-efficacy
Lasso di tempo: 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).
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Mindfulness
Lasso di tempo: 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
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Physical Activity Level
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Quality of Life (QOL)
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Anxiety and Depressive Symptoms
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Perceived Stress
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Fatigue
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Comorbidities
Lasso di tempo: 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.
|
Baseline
|
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Acculturation
Lasso di tempo: 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.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
Lasso di tempo: 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.
|
3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
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Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
Lasso di tempo: 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.
|
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
Lasso di tempo: 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.
|
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
Lasso di tempo: 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.
|
3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
|
Perceived exertion
Lasso di tempo: 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.
|
Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.
|
|
Treatment Credibility and Expectancy
Lasso di tempo: 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.
|
During the first week of the intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Evelyn Arana, DrPH, Rutgers Cancer Institute
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
2 settembre 2026
Completamento primario (Stimato)
1 luglio 2031
Completamento dello studio (Stimato)
1 luglio 2031
Date di iscrizione allo studio
Primo inviato
25 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 agosto 2026
Primo Inserito (Effettivo)
2 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro2026001619
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .