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

ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Body Mind Training

    Behavioral

    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 - Insomnia

    Behavioral

    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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Body Mind TrainingExperimental treatment 1 intervention
Group B: Cognitive Behavioral Therapy - InsomniaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Recruitment Rate

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

Time frame
1-2 weeks post-intervention
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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