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CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBTI-CS

Sleep Hygiene

CBTI-CS via Telehealth

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia cancer Survivor

Eligibility Criteria

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

Inclusion Criteria:

-≥ 18 years of age

History of a cancer diagnosis
No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
No surgery planned in the next 6 months
Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
Able to read and write in English
Willing to attend study group sessions
Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep.

Exclusion Criteria:

Survivors who report ever being diagnosed with Bipolar Disorder will be excluded.
Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded.
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period.
Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder
Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.

Sites / Locations

Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm A (Sleep Hygiene & CBTI-CS)

Arm B (Telehealth Pilot of CBTI-CS)

Arm Description

Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions

Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.

Outcomes

Primary Outcome Measures

The Insomnia Severity Index (ISI)

The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Secondary Outcome Measures

Profile of Mood States - Short Form (POMS-SF)

A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance.

The Insomnia Severity Index (ISI)

The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Full Information

NCT ID

NCT02756390

First Posted

April 26, 2016

Last Updated

December 10, 2018

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02756390

Brief Title

CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

Official Title

CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 14, 2018 (Actual)

Study Completion Date

May 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.

Detailed Description

This study is being done to test the usefulness of a 3-session cognitive-behavioral intervention for improving insomnia in cancer survivors. In this study, the investigators are testing whether this 3-session intervention (Cognitive Behavior Therapy for Insomnia in Cancer Survivors: CBTI-CS) will improve insomnia in cancer survivors whose continue to have insomnia symptoms after receiving sleep hygiene education. In addition to the participants who will be offered sleep hygiene education and the 3-session CBTI-CS,10 additional participants will be recruited to participate in a pilot evaluation of the CBTI-CS intervention delivered via telehealth. This will be a pilot aspect of the study and data from these participants will be for descriptive purposes.

6. Conditions and Keywords

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

Insomnia

Keywords

Insomnia cancer Survivor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (Sleep Hygiene & CBTI-CS)

Arm Type

Experimental

Arm Description

Arm Title

Arm B (Telehealth Pilot of CBTI-CS)

Arm Type

Other

Arm Description

Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.

Intervention Type

Behavioral

Intervention Name(s)

CBTI-CS

Other Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia -Cancer Survivors

Intervention Description

CBTI-CS is a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia. Cognitive factors are addressed via cognitive restructuring and psychoeducation. Behavioral factors are addressed by structured sleep restriction, stimulus control and sleep hygiene techniques. Cancer treatment late-effects affecting sleep are addressed as potential contributors to these cognitive and behavioral factors, and as symptoms that may benefit from referral for medical evaluation/management. Participants are instructed in these cognitive-behavioral strategies as a group, but using analysis of personal sleep-log data, symptom self-reports and targeted workbook exercises, they are helped to tailor the intervention to address their specific needs.

Intervention Type

Behavioral

Intervention Name(s)

Sleep Hygiene

Intervention Description

Education on health behaviors, sleep habits and environmental practices intended to promote good quality sleep. Recommendations target exercise and natural light exposure,use of stimulants and alcohol, daytime napping, timing of meals, creating a comfortable non-stimulating sleep space, and creating sleep rituals.

Intervention Type

Behavioral

Intervention Name(s)

CBTI-CS via Telehealth

Intervention Description

The CBTI-CS intervention, a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia, will be administered via live video. conferencing. Participants will have a single in-person training session and subsequent CBTI-CS group sessions will be conducted by live video conference.

Primary Outcome Measure Information:

Title

The Insomnia Severity Index (ISI)

Description

The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Time Frame

Change from Baseline to 4-weeks post-intervention

Secondary Outcome Measure Information:

Title

Profile of Mood States - Short Form (POMS-SF)

Description

A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance.

Time Frame

Change from Baseline to 4 & 8 weeks post-intervention

Title

The Insomnia Severity Index (ISI)

Description

The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Time Frame

Change from Baseline to 8 weeks post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -≥ 18 years of age History of a cancer diagnosis No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months No surgery planned in the next 6 months Significant insomnia as evidenced by an Insomnia Severity Index score ≥12 Able to read and write in English Willing to attend study group sessions Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep. Exclusion Criteria: Survivors who report ever being diagnosed with Bipolar Disorder will be excluded. Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded. Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period. Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery) Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Recklitis, PhD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26872123

Citation

Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12.

Results Reference

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CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

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