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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Sleep Disturbance

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04101526

MCC-20086

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Pre-Intervention Qualitative Interviews

No Intervention group

Description:

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.

Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

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

Treatment:

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

Waitlist control group

No Intervention group

Description:

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.