NCT02756390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

April 26, 2016

Last Update Submit

December 10, 2018

Conditions

Insomnia

Keywords

Insomnia cancer Survivor

Outcome Measures

Primary Outcomes (1)

  • The Insomnia Severity Index (ISI)

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

    Change from Baseline to 4-weeks post-intervention

Secondary Outcomes (2)

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

    Change from Baseline to 4 & 8 weeks post-intervention

  • The Insomnia Severity Index (ISI)

    Change from Baseline to 8 weeks post-intervention

Study Arms (2)

Arm A (Sleep Hygiene & CBTI-CS)

EXPERIMENTAL

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

Behavioral: CBTI-CSBehavioral: Sleep Hygiene

Arm B (Telehealth Pilot of CBTI-CS)

OTHER

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

Behavioral: CBTI-CS via Telehealth

Interventions

CBTI-CSBEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy for Insomnia -Cancer Survivors
Arm A (Sleep Hygiene & CBTI-CS)
Sleep HygieneBEHAVIORAL

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.

Arm A (Sleep Hygiene & CBTI-CS)
CBTI-CS via TelehealthBEHAVIORAL

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.

Arm B (Telehealth Pilot of CBTI-CS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 26872123BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christopher Recklitis, PhD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christopher Recklitis, PhD, MPH

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 29, 2016

Study Start

December 1, 2015

Primary Completion

May 14, 2018

Study Completion

May 14, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)