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Completed

NCT Number: NCT04101526

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

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

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ponce Health Services University, Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances

    Time frame: 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).

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

    Time frame: 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 outcomes

  1. Efficacy of New Intervention Using PSQI Scoring

    Time frame: 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

  2. Efficacy of New Intervention Using ISI Scoring

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2019
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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