Trial Outcomes & Findings for Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance (NCT NCT04101526)

Last Updated: 2024-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline

Results posted on

2024-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Did not complete all sleep diary entries	0	1

Baseline Characteristics

Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) n=15 Participants 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.	Waitlist Control Group n=15 Participants 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.	Total n=30 Participants Total of all reporting groups
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Puerto Rico	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 33 eligible candidates were approached for participation in the trial

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.

Outcome measures

Outcome measures
Measure	Eligible Cancer Survivors Who Were Approached Agreed to Participate n=33 Participants Recruitment rates are calculated for all potential study candidates.	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.
Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances	30 Participants	—

PRIMARY outcome

Timeframe: Approximately 6 weeks after first intervention session

Population: Data was not collected from the participants in the "Wait list Control Group"

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).

Outcome measures

Outcome measures
Measure	Eligible Cancer Survivors Who Were Approached Agreed to Participate n=15 Participants Recruitment rates are calculated for all potential study candidates.	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.
Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances	3.56 score on a scale Standard Deviation 0.28	—

PRIMARY outcome

Timeframe: approximately 6 weeks after first intervention session

Population: Data was not collected from the participants in the "Wait list Control Group"

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.

Outcome measures

Outcome measures
Measure	Eligible Cancer Survivors Who Were Approached Agreed to Participate n=15 Participants Recruitment rates are calculated for all potential study candidates.	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.
Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances	15 Participants	—

SECONDARY outcome

Timeframe: Baseline and approximately 6 weeks after first intervention session

Population: 1 participant in wait list control group did not complete all sleep dairy entries.

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

Outcome measures

Outcome measures
Measure	Eligible Cancer Survivors Who Were Approached Agreed to Participate n=15 Participants Recruitment rates are calculated for all potential study candidates.	Waitlist Control Group n=15 Participants 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.
Efficacy of New Intervention Using PSQI Scoring Baseline	11.60 score on a scale Standard Deviation 3.74	11.57 score on a scale Standard Deviation 3.25
Efficacy of New Intervention Using PSQI Scoring 6 week follow up after intervention	7.40 score on a scale Standard Deviation 3.25	11.77 score on a scale Standard Deviation 3.72

SECONDARY outcome

Timeframe: Baseline and approximately 6 weeks after first intervention session

Population: 1 participant in wait list control group did not complete all sleep dairy entries.

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

Outcome measures

Outcome measures
Measure	Eligible Cancer Survivors Who Were Approached Agreed to Participate n=15 Participants Recruitment rates are calculated for all potential study candidates.	Waitlist Control Group n=15 Participants 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.
Efficacy of New Intervention Using ISI Scoring Baseline	18.87 score on a scale Standard Deviation 4.49	17.20 score on a scale Standard Deviation 4.49
Efficacy of New Intervention Using ISI Scoring 6 week follow up after intervention	7.80 score on a scale Standard Deviation 3.75	13.33 score on a scale Standard Deviation 6.69

Adverse Events

Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian Gonzalez

Moffitt Cancer Center

Phone: 813-745-3219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place