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The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian D Gonzalez, PhD | H. Lee Moffitt Cancer and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Lee Moffitt Cancer and Research Institute | Tampa | Florida | 33612 | United States | ||
| Ponce Health Services University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | 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. | |
| 35438442 | Derived | Oswald 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. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2022 |
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| 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 | Baseline and approximately 6 weeks after first intervention session |
| Ponce |
| 00732-7004 |
| Puerto Rico |
| FG001 | Waitlist Control Group | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference: 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. |
| BG001 | Waitlist Control Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 33 eligible candidates were approached for participation in the trial | Posted | Count of Participants | Participants | Baseline |
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| Primary | 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). | Data was not collected from the participants in the "Wait list Control Group" | Posted | Mean | Standard Deviation | score on a scale | Approximately 6 weeks after first intervention session |
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| Primary | 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. | Data was not collected from the participants in the "Wait list Control Group" | Posted | Count of Participants | Participants | approximately 6 weeks after first intervention session |
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| Secondary | 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 | 1 participant in wait list control group did not complete all sleep dairy entries. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 6 weeks after first intervention session |
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| Secondary | 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 | 1 participant in wait list control group did not complete all sleep dairy entries. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 6 weeks after first intervention session |
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Adverse events were collected from the first day of being on study until participant was off study, an average of 6 weeks.
No Adverse Events were reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Waitlist Control Group | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Gonzalez | Moffitt Cancer Center | 813-745-3219 | Brian.Gonzalez@moffitt.org |
| May 23, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2020 | May 24, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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