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

Primary Purpose

Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • H Lee Moffitt Cancer and Research Institute
  • Ponce Health Services University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Pre-Intervention Qualitative Interviews

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

Waitlist control group

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2019
Last Updated
January 19, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04101526
Brief Title
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
Official Title
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention Qualitative Interviews
Arm Type
No Intervention
Arm 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.
Arm Title
Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
Intervention Description
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 Outcome Measure Information:
Title
Acceptability of New Intervention for Cancer-Related Sleep Disturbances
Description
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).
Time Frame
approximately 6 weeks after first intervention session
Title
Feasibility of New Intervention for Cancer-Related Sleep Disturbances
Description
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.
Time Frame
approximately 6 weeks after first intervention session
Secondary Outcome Measure Information:
Title
Efficacy of New Intervention
Description
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.
Time Frame
approximately 6 weeks after first intervention session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Gonzalez, PhD
Organizational Affiliation
H. Lee Moffitt Cancer and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Lee Moffitt Cancer and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Ponce Health Services University
City
Ponce
ZIP/Postal Code
00732-7004
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35438442
Citation
Oswald LB, Morales-Cruz J, Eisel SL, Del Rio J, Hoogland AI, Ortiz-Rosado V, Soto-Lopez G, Rodriguez-Rivera E, Savard J, Castro E, Jim HSL, Gonzalez BD. Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. J Behav Med. 2022 Jun;45(3):503-508. doi: 10.1007/s10865-022-00313-6. Epub 2022 Apr 19.
Results Reference
derived

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

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