Feasibility of Internet Group CBT-I for Gyn Oncology Patients

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Insomnia

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer Must have access to internet Be able to connect via secure web-based platform Be able to complete online questionnaires Moderate or severe insomnia Have access to a mobile device or computer Exclusion Criteria: Participants without ability to connect with both audio and visual through secure web-based platform Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible Participants with remote history of insomnia, but not currently having symptoms of insomnia Have other reasons for poor sleep

Sites / Locations

University of California, Davis Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT-I online group

Arm Description

Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting.

Outcomes

Primary Outcome Measures

Attendance

Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed.

Acceptability

A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable.

Secondary Outcome Measures

Insomnia symptoms

Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia

Changes in quality of life symptoms

Measured by the 7-item Functional Assessment of Cancer Therapy (FACT-G7) Assessment, with likhert scales from 0-4 and higher numbers indicating more severe symptoms

Sleep Quality

Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.

Full Information

NCT ID

NCT06060158

First Posted

June 29, 2023

Last Updated

September 23, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT06060158

Brief Title

Feasibility of Internet Group CBT-I for Gyn Oncology Patients

Official Title

Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

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 goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting. Secondary objectives: To compare insomnia symptoms before and after intervention. To evaluate any changes in quality of life symptoms while undergoing the intervention. To evaluate the duration of symptoms improvement after the intervention is complete.

Detailed Description

This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.

6. Conditions and Keywords

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

Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This is a pilot feasibility study looking at delivering small group therapy online.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBT-I online group

Arm Type

Experimental

Arm Description

Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia

Intervention Description

6 sessions

Primary Outcome Measure Information:

Title

Attendance

Description

Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed.

Time Frame

6 weeks

Title

Acceptability

Description

A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Insomnia symptoms

Description

Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia

Time Frame

24 weeks

Title

Changes in quality of life symptoms

Description

Measured by the 7-item Functional Assessment of Cancer Therapy (FACT-G7) Assessment, with likhert scales from 0-4 and higher numbers indicating more severe symptoms

Time Frame

24 weeks

Title

Sleep Quality

Description

Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer Must have access to internet Be able to connect via secure web-based platform Be able to complete online questionnaires Moderate or severe insomnia Have access to a mobile device or computer Exclusion Criteria: Participants without ability to connect with both audio and visual through secure web-based platform Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible Participants with remote history of insomnia, but not currently having symptoms of insomnia Have other reasons for poor sleep

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katie Van Deventer, MD

Phone

916-734-6900

Email

kvandev@ucdavis.edu

First Name & Middle Initial & Last Name or Official Title & Degree

UC Davis Comprehensive Cancer Center

Phone

916-734-6900

Email

HS-CBTIStudy@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Chen, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis Comprehensive Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

No

Insomnia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial