Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
1 other identifier
interventional
30
2 countries
2
Brief Summary
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2019
CompletedFirst Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2021
CompletedResults Posted
Study results publicly available
October 29, 2024
CompletedOctober 29, 2024
October 1, 2024
1.5 years
September 23, 2019
May 23, 2023
October 28, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
The study will be deemed acceptable if ≥ 50% of eligible cancer survivors who are approached agree to participate. Recruitment rate will be measured by percentage of patients enrolled.
Baseline
Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
The study will be deemed acceptable if \> 50% of intervention group participants report that, on average, they agree with positive statements about the intervention (i.e., report an average score of \>3 on a scale of 0 to 4).
Approximately 6 weeks after first intervention session
Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances
The study will be deemed feasible if ≥ 75% of the intervention group participants attend at least half of the educational components of the intervention. This will be operationalized as having attended at least half of the sessions.
approximately 6 weeks after first intervention session
Secondary Outcomes (2)
Efficacy of New Intervention Using PSQI Scoring
Baseline and approximately 6 weeks after first intervention session
Efficacy of New Intervention Using ISI Scoring
Baseline and approximately 6 weeks after first intervention session
Study Arms (3)
Pre-Intervention Qualitative Interviews
NO INTERVENTIONQualitative interviews will be conducted with breast cancer survivors, survivors' caregivers, cancer support group leaders and clinicians regarding sleep disturbance in breast cancer survivors and preferences for an intervention for sleep disturbance.
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)
EXPERIMENTALBehavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
Waitlist control group
NO INTERVENTIONNo intervention until 6 weeks after the baseline assessment, at which point participants complete a follow-up assessment and then are offered the new CBT-I intervention.
Interventions
Six sessions of Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference. Sessions address topics such as sleep education, sleep hygiene, sleep restriction, stimulus control, relapse prevention, and cognitive restructuring.
Eligibility Criteria
You may qualify if:
- Located in the Southern Puerto Rico area
- Able to speak and read Spanish
- Have no documented or observable disabilities that would interfere with study participation
- Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation)
- Has clinically significant sleep disturbance (i.e., \>/= 8 on the Insomnia Severity Index)
- Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy
- Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software
You may not qualify if:
- Not able to read and speak Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
H Lee Moffitt Cancer and Research Institute
Tampa, Florida, 33612, United States
Ponce Health Services University
Ponce, 00732-7004, Puerto Rico
Related Publications (2)
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PMID: 41170811DERIVEDOswald LB, Morales-Cruz J, Eisel SL, Del Rio J, Hoogland AI, Ortiz-Rosado V, Soto-Lopez G, Rodriguez-Rivera E, Savard J, Castro E, Jim HSL, Gonzalez BD. Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. J Behav Med. 2022 Jun;45(3):503-508. doi: 10.1007/s10865-022-00313-6. Epub 2022 Apr 19.
PMID: 35438442DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Brian Gonzalez
- Organization
- Moffitt Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Brian D Gonzalez, PhD
H. Lee Moffitt Cancer and Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 24, 2019
Study Start
August 15, 2019
Primary Completion
March 1, 2021
Study Completion
April 9, 2021
Last Updated
October 29, 2024
Results First Posted
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share