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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2021-04-09

Brief Summary

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

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Detailed Description

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Conditions

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Sleep Disturbance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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