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Brief Behavioral Treatment for Insomnia in Cancer Survivors

Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03810365
Enrollment
132
Registered
2019-01-18
Start date
2019-06-06
Completion date
2023-11-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insomnia

Keywords

Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention

Brief summary

The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

Detailed description

A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).

Interventions

BEHAVIORALBrief behavioral treatment for insomnia

Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.

BEHAVIORALHealthy Eating Control

Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.

Sponsors

Roswell Park Cancer Institute
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer * chronic insomnia

Exclusion criteria

* Other preexisting sleep disorders except those with OSA stable on CPAP * Unstable medical illnesses

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity Indexone monthOne 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
66
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.
66
Total132

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudyWithdrawal by Subject45

Baseline characteristics

CharacteristicBehavioral: Brief Behavioral Treatment for InsomniaBehavioral: Healthy Eating ControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
24 Participants38 Participants62 Participants
Age, Categorical
Between 18 and 65 years
42 Participants28 Participants70 Participants
Age, Continuous62.26 years
STANDARD_DEVIATION 11.21
65.11 years
STANDARD_DEVIATION 8.54
63.68 years
STANDARD_DEVIATION 10.03
Insomnia Severity Index12.56 units on a scale
STANDARD_DEVIATION 3.61
14.26 units on a scale
STANDARD_DEVIATION 4.33
13.41 units on a scale
STANDARD_DEVIATION 4.06
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
4 Participants5 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants4 Participants
Race (NIH/OMB)
White
59 Participants58 Participants117 Participants
Region of Enrollment
United States
66 Participants66 Participants132 Participants
Sex: Female, Male
Female
36 Participants36 Participants72 Participants
Sex: Female, Male
Male
30 Participants30 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 620 / 60
other
Total, other adverse events
0 / 620 / 60
serious
Total, serious adverse events
0 / 620 / 60

Outcome results

Primary

Insomnia Severity Index

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Behavioral: Brief Behavioral Treatment for InsomniaInsomnia Severity Index7.03 score on a scale
Behavioral: Healthy Eating ControlInsomnia Severity Index9.26 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026