Trial Outcomes & Findings for Brief Behavioral Treatment for Insomnia in Cancer Survivors (NCT NCT03810365)

Last Updated: 2024-07-03

Results Overview

One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

one month

Results posted on

2024-07-03

Participant Flow

Participants were recruited from a major comprehensive cancer center and ancillary sites in WNY between 6/2019 and 10/2022. The first participant was enrolled 6/6/2019 and last participant was enrolled 9/26/2022. Date of last participant's last visit 11/01/2023.

Approached for study- n=402, Excluded- n=266 \[not meeting inclusion criteria- n=75, Declined to participate- n=47, No response after initial contact- n=144, Total participants completing screening n=136, however, 4 participants quit prior to randomization. Final total enrolled participants = 132 with 66 in experimental and 66 in the control group.

Participant milestones

Participant milestones
Measure	Behavioral: Brief Behavioral Treatment for Insomnia Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Brief behavioral treatment for insomnia: Brief behavioral Managment of Insomnia content with 1 month 3 month 12 month follow-up visits.	Behavioral: Healthy Eating Control Healthy eating control involves a 45 minute individual session with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
Overall Study STARTED	66	66
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral: Brief Behavioral Treatment for Insomnia Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Brief behavioral treatment for insomnia: Brief behavioral Managment of Insomnia content with 1 month 3 month 12 month follow-up visits.	Behavioral: Healthy Eating Control Healthy eating control involves a 45 minute individual session with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	4	5

Baseline Characteristics

Brief Behavioral Treatment for Insomnia in Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral: Brief Behavioral Treatment for Insomnia n=66 Participants Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.	Behavioral: Healthy Eating Control n=66 Participants Healthy eating control involves a 45 minute individual session with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	28 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	38 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	62.26 years STANDARD_DEVIATION 11.21 • n=5 Participants	65.11 years STANDARD_DEVIATION 8.54 • n=7 Participants	63.68 years STANDARD_DEVIATION 10.03 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Insomnia Severity Index	12.56 units on a scale STANDARD_DEVIATION 3.61 • n=5 Participants	14.26 units on a scale STANDARD_DEVIATION 4.33 • n=7 Participants	13.41 units on a scale STANDARD_DEVIATION 4.06 • n=5 Participants

PRIMARY outcome

Timeframe: one month

Population: The main efficacy was determined at one month after the intervention. The study continued with measurements at 3 months and 12 months to determine durability. additional participants dropped out and the final numbers in the study were 60 experimental and 59 control.

Outcome measures

Outcome measures
Measure	Behavioral: Brief Behavioral Treatment for Insomnia n=62 Participants Brief behavioral treatment for insomnia intervention includes 45 minute individual intervention with two follow up phone calls.with 1 month followup for Insomnia Severity Index measure	Behavioral: Healthy Eating Control n=60 Participants Healthy eating control involves a 45 minute individual session with two follow up phone calls with one month followup for Insomnia severity Index measure.
Insomnia Severity Index	7.03 score on a scale Interval 5.78 to 8.28	9.26 score on a scale Interval 7.9 to 10.62

Adverse Events

Behavioral: Brief Behavioral Treatment for Insomnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral: Healthy Eating Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Suzanne S. Dickerson

School of Nursing, University at Buffalo

Phone: 716-829-3254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place