Brief Behavioral Treatment for Insomnia in Cancer Survivors

NCT03810365 | Completed Results DMC

• 2 other identifiers: STUDY000028981R01NR018215
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  one month

Study Arms (2)

Behavioral: Brief behavioral treatment for insomnia

EXPERIMENTAL

Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Behavioral: Brief behavioral treatment for insomnia

Behavioral: Healthy eating control

ACTIVE COMPARATOR

Healthy eating control involves a 45 minute individual session with two follow up phone calls.

Behavioral: Healthy Eating Control

Interventions

Brief behavioral treatment for insomnia BEHAVIORAL

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.

Behavioral: Brief behavioral treatment for insomnia

Healthy Eating Control BEHAVIORAL

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

Behavioral: Healthy eating control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Roswell Park Cancer Institute: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Related Publications (5)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

• Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae096. doi: 10.1093/abm/kaae096.

  PMID: 39887070 DERIVED

• Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2024 Nov 26. doi: 10.1007/s11764-024-01704-1. Online ahead of print.

  PMID: 39589721 DERIVED

• Kwon M, Zhu J, Wilding GE, Dickerson SS, Dean GE. Sleep-wake state discrepancy among cancer survivors with insomnia symptoms. Support Care Cancer. 2023 Dec 4;32(1):2. doi: 10.1007/s00520-023-08177-5.

  PMID: 38047967 DERIVED

• Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28.

  PMID: 36182027 DERIVED

Related Links

• Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.
• A primary care "friendly" cognitive behavioral insomnia therapy.
• Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.
• Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.
• How to provide insomnia interventions to people with cancer: insights from patients.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr Suzanne S. Dickerson
• Organization: School of Nursing, University at Buffalo

sdickers@buffalo.edu

716-829-3254

Study Officials

• Suzanne S. Dickerson, PhD

  University at Buffalo, School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: June 6, 2019
• Primary Completion: November 17, 2022
• Study Completion: November 1, 2023
• Last Updated: July 3, 2024
• Results First Posted: November 30, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)