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

October 28, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00732-7004
        • Ponce Health Services University
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-Intervention Qualitative Interviews
Qualitative interviews will be conducted with breast cancer survivors, survivors' caregivers, cancer support group leaders and clinicians regarding sleep disturbance in breast cancer survivors and preferences for an intervention for sleep disturbance.
Experimental: Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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).
Approximately 6 weeks after first intervention session
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.
approximately 6 weeks after first intervention session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and approximately 6 weeks after first intervention session
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
Baseline and approximately 6 weeks after first intervention session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Brian D Gonzalez, PhD, H. Lee Moffitt Cancer and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

April 9, 2021

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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