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

NCT07800715 | Not Yet Recruiting

• 1 other identifier: Pro2026001619
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  1-2 weeks post-intervention

• Actigraphy adherence rate

  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

  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

  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

Secondary Outcomes (16)

• Pittsburgh Sleep Quality Index

  Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

• Sleep self-efficacy

  Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

• Mindfulness

  Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

• Physical Activity Level

  Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

• Quality of Life (QOL)

  Baseline, 1-2 weeks post-intervention, and 3 months post-intervention

Study Arms (2)

Body Mind Training

EXPERIMENTAL

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.

Behavioral: Body Mind Training

Cognitive Behavioral Therapy - Insomnia

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy - Insomnia

Interventions

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.

Body Mind Training

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.

Cognitive Behavioral Therapy - Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to speak and read English or Spanish proficiently
• Life expectancy \<12 months
• Aims 2-3 (RCT):
• 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)
• Current or last year practice of TCQ or similar practices;
• Current or past CBT-I treatment,
• Shift worker,
• Life expectancy \<12 months,

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Evelyn Arana, DrPH

  Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Arana, DrPH

CONTACT

9086420861; earana@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 2, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share