Sleep DisturbanceNCT04101526
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
A study testing Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference in people with Sleep Disturbance, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
Trial summary
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Aug 2019to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to read and speak Spanish
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
H Lee Moffitt Cancer and Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
- Conditions
- Sleep Disturbance
- Being tested
- Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconferenceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention Qualitative Interviews | No intervention | Qualitative 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) | Experimental | Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference Receives: Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference |
| Waitlist control group | No intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: approximately 6 weeks after first intervention session
Secondary outcomes (2)
Efficacy of New Intervention Using PSQI Scoring
Pittsburgh Sleep Quality Index (PSQI) Scoring:
Duration of Sleep, Sleep Disturbance, Sleep Latency, Days of Disfunction due to Sleepiness, Sleep Efficiency, Overall Sleep Quality, and Meds Needed to Sleep Response Scale 0 (better) 3 (worse). Total Minimum Score 0 (Better), Total Maximum Score 21 (Worse)
≤ 5 = Good Sleep Quality >5 = Poor Sleep Quality
Measured: Baseline and approximately 6 weeks after first intervention session
Efficacy of New Intervention Using ISI Scoring
Insomnia Severity Index (ISI) Scoring:
Sleep Quality, Symptom Severity, Sleep Patterns, Daily Functioning, Insomnia Noticeable to Others, Level of Distress Caused by Insomnia Response Scale 0 (better) 4 (worse) Total Minimum Score 0 (Better) Total Maximum Score 28 (Worse)
0-7: No Clinically Significant Insomnia 8-14: Subthreshold Insomnia 15-21: Clinical Insomnia 22-28: Severe Clinical Insomnia
Measured: Baseline and approximately 6 weeks after first intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Aug 2019
- Primary completion1 Mar 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian D Gonzalez, PhD, Principal investigator, H. Lee Moffitt Cancer and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101526
- Sponsor's protocol ID
- MCC-20086
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2019
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41170811Oswald 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.
PubMed 35438442
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
- ClinicalTrials.gov ID
- NCT04101526
- Acronym / sponsor ID
- MCC-20086
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Qualitative Interviews | No intervention | –Qualitative 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) | Experimental | Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconferenceBehavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference |
| Waitlist control group | No intervention | –No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Not able to read and speak Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconferenceSix 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. | Behavioural | Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
Primary outcome
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
Time frame: Baseline
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.
Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
Time frame: Approximately 6 weeks after first intervention session
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).
Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances
Time frame: approximately 6 weeks after first intervention session
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.
2 secondary outcomes
Efficacy of New Intervention Using PSQI Scoring
Time frame: Baseline and approximately 6 weeks after first intervention session
Efficacy of New Intervention Using ISI Scoring
Time frame: Baseline and approximately 6 weeks after first intervention session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41170811Cai 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.
- Derived from this study: PubMed 35438442Oswald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D Gonzalez, PhD principal investigator
H. Lee Moffitt Cancer and Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference in people with Sleep Disturbance, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.