NCT04101526

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

Completed NA Results posted Last updated 29 October 2024

What this trial tests

NA trial testing Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference in Sleep Disturbance in 30 participants. Completed in 9 April 2021.

Timeline

15 August 2019

Primary endpoint
1 March 2021

9 April 2021

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	15 August 2019
Primary completion	1 March 2021
Estimated completion	9 April 2021
Sites	2 locations across Puerto Rico, United States

Drugs / interventions tested

• Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference

Conditions studied

• Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances Primary · 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.

Group	Value	95% CI
Eligible Cancer Survivors Who Were Approached Agreed to Participate	30

Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances Primary · 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).

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	3.56	± 0.28

Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances Primary · 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.

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	15

Efficacy of New Intervention Using PSQI Scoring Secondary · 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

Baseline

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	11.60	± 3.74
Waitlist Control Group	11.57	± 3.25

6 week follow up after intervention

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	7.40	± 3.25
Waitlist Control Group	11.77	± 3.72

Efficacy of New Intervention Using ISI Scoring Secondary · 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

Baseline

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	18.87	± 4.49
Waitlist Control Group	17.20	± 4.49

6 week follow up after intervention

Group	Value	95% CI
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)	7.80	± 3.75
Waitlist Control Group	13.33	± 6.69

Sponsor's own description

The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors.
   Oswald LB, Morales-Cruz J, Eisel SL, Del Rio J, et al · · 2022 · cited 15× · PMID 35438442 · DOI 10.1007/s10865-022-00313-6