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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101526
• Other study ID #: MCC-20086
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: April 9, 2021

Study information

• Verified date: January 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 9, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	Ponce Health Services University	Ponce
United States	H Lee Moffitt Cancer and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and > 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
Primary	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.	approximately 6 weeks after first intervention session
Secondary	Efficacy of New Intervention	Efficacy of the newly created intervention will be assessed using (a) Scores on the Pittsburgh Sleep Quality Index, which consists of 19 individual items creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the 7 component scores, producing a score ranging from 0-21, where lower scores denote a healthier sleep quality. (b) the Insomnia Severity Index, which has 7 questions on a 0-4 scale. Items are totaled to produce a score ranging from 0-28, where higher scores denote worse insomnia severity.	approximately 6 weeks after first intervention session

External Links

•   Moffitt Cancer Center Clinical Trials website