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

N/ACompletedNCT04101526

H. Lee Moffitt Cancer Center and Research Institute30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sleep Disturbance

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

H Lee Moffitt Cancer and Research Institute

Tampa, Florida, United States

Ponce Health Services University

Ponce, Puerto Rico

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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