Clinical trial · Interventional
Developing and Testing of Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
Developing and Testing of Culturally Appropriate Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
NCT07800715CI-TRIAL-00125314not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Body Mind Training | Behavioral | — | UNRESOLVED |
| Cognitive Behavioral Therapy - Insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Body Mind Training
- description
- 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.
- interventionNames
- Behavioral: Body Mind Training
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Therapy - Insomnia
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy - Insomnia
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.