Sleep Disturbance
Conditions
Brief summary
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
Interventions
BEHAVIORALSpanish-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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Not able to read and speak Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of New Intervention Using PSQI Scoring | Baseline and approximately 6 weeks after first intervention session | 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 |
| Efficacy of New Intervention Using ISI Scoring | Baseline and approximately 6 weeks after first intervention session | 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 |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete all sleep diary entries | 0 | 1 |
Baseline characteristics
| Characteristic | Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Waitlist Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 11 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 15 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment Puerto Rico | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: approximately 6 weeks after first intervention session
Population: Data was not collected from the participants in the Wait list Control Group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances | 15 Participants |
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.
Time frame: Baseline
Population: 33 eligible candidates were approached for participation in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances | 30 Participants |
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).
Time frame: Approximately 6 weeks after first intervention session
Population: Data was not collected from the participants in the Wait list Control Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances | 3.56 score on a scale | Standard Deviation 0.28 |
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
Time frame: Baseline and approximately 6 weeks after first intervention session
Population: 1 participant in wait list control group did not complete all sleep dairy entries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Efficacy of New Intervention Using ISI Scoring | Baseline | 18.87 score on a scale | Standard Deviation 4.49 |
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Efficacy of New Intervention Using ISI Scoring | 6 week follow up after intervention | 7.80 score on a scale | Standard Deviation 3.75 |
| Waitlist Control Group | Efficacy of New Intervention Using ISI Scoring | Baseline | 17.20 score on a scale | Standard Deviation 4.49 |
| Waitlist Control Group | Efficacy of New Intervention Using ISI Scoring | 6 week follow up after intervention | 13.33 score on a scale | Standard Deviation 6.69 |
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
Time frame: Baseline and approximately 6 weeks after first intervention session
Population: 1 participant in wait list control group did not complete all sleep dairy entries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Efficacy of New Intervention Using PSQI Scoring | Baseline | 11.60 score on a scale | Standard Deviation 3.74 |
| Eligible Cancer Survivors Who Were Approached Agreed to Participate | Efficacy of New Intervention Using PSQI Scoring | 6 week follow up after intervention | 7.40 score on a scale | Standard Deviation 3.25 |
| Waitlist Control Group | Efficacy of New Intervention Using PSQI Scoring | Baseline | 11.57 score on a scale | Standard Deviation 3.25 |
| Waitlist Control Group | Efficacy of New Intervention Using PSQI Scoring | 6 week follow up after intervention | 11.77 score on a scale | Standard Deviation 3.72 |