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Improving Sleep in Cancer Patients: A Feasibility Trial (ISCAP)

Primary Purpose

Cancer, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, insomnia, CBT, CBT-I, cognitive behavioral therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. 18+ years of age
  2. have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments)
  3. are diagnosed with gastro-intestinal cancer;
  4. have life expectancy > 6 months;
  5. are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure;
  6. will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I;
  7. are English-speaking and able to provide voluntary, written consent.

Exclusion Criteria:

  1. unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment;
  2. other sleep disorders;
  3. bipolar disorder;
  4. unmanaged serious mental illnesses;
  5. suicidal ideation/intent/plan;
  6. unstabilized pharmacological treatment for insomnia;
  7. night-shift employment.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Receiving CBT-I

Arm Description

This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).

Outcomes

Primary Outcome Measures

Change of the score on the Insomnia Severity Index (ISI)
The ISI assesses the severity of insomnia symptoms and subjective daytime impairments.

Secondary Outcome Measures

Change of diary-assessed sleep onset latency
Sleep onset latency is the time it takes to fall asleep
Change of diary-assessed wake after sleep onset
wake after sleep onset is the total duration of nighttime awakenings
Change of actigraphy-sleep onset latency
Sleep onset latency is the time it takes to fall asleep
Change of actigraphy-assessed wake after sleep onset
wake after sleep onset is the total duration of nighttime awakenings

Full Information

First Posted
May 25, 2018
Last Updated
April 9, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03561064
Brief Title
Improving Sleep in Cancer Patients: A Feasibility Trial
Acronym
ISCAP
Official Title
Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

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 determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.
Detailed Description
This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Insomnia
Keywords
cancer, insomnia, CBT, CBT-I, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Receiving CBT-I
Arm Type
Experimental
Arm Description
This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Other Intervention Name(s)
cognitive behavioral therapy for insomnia
Intervention Description
Eligible participants will receive CBT-I by a licensed clinical psychologist.
Primary Outcome Measure Information:
Title
Change of the score on the Insomnia Severity Index (ISI)
Description
The ISI assesses the severity of insomnia symptoms and subjective daytime impairments.
Time Frame
baseline and at 19th week
Secondary Outcome Measure Information:
Title
Change of diary-assessed sleep onset latency
Description
Sleep onset latency is the time it takes to fall asleep
Time Frame
baseline and at 19th week
Title
Change of diary-assessed wake after sleep onset
Description
wake after sleep onset is the total duration of nighttime awakenings
Time Frame
baseline and at 19th week
Title
Change of actigraphy-sleep onset latency
Description
Sleep onset latency is the time it takes to fall asleep
Time Frame
baseline and at 19th week
Title
Change of actigraphy-assessed wake after sleep onset
Description
wake after sleep onset is the total duration of nighttime awakenings
Time Frame
baseline and at 19th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18+ years of age have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments) are diagnosed with gastro-intestinal cancer; have life expectancy > 6 months; are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure; will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I; are English-speaking and able to provide voluntary, written consent. Exclusion Criteria: unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment; other sleep disorders; bipolar disorder; unmanaged serious mental illnesses; suicidal ideation/intent/plan; unstabilized pharmacological treatment for insomnia; night-shift employment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai S Chan, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.

Learn more about this trial

Improving Sleep in Cancer Patients: A Feasibility Trial

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