NCT05226078

Brief Summary

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress85%
Mar 2023Nov 2026

First Submitted

Initial submission to the registry

December 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

3.5 years

First QC Date

December 7, 2021

Last Update Submit

May 15, 2025

Conditions

Chronic InsomniaCancer-related Problem/ConditionCancer-Related Syndrome

Keywords

InsomniaFatigueCBT-IDose ResponseCancer-Related Fatigue

Outcome Measures

Primary Outcomes (4)

  • Recruitment

    Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.

    Baseline to End of Treatment (Up to 12 weeks)

  • Adherence

    Average adherence to Sleep Restriction Therapy (SRT) and Stimulus Control Therapy (SCT) \[overall and by week\] as measured by deviations between prescribed and actual times (from sleep diaries), overall and by group.

    Baseline to End of Treatment (Up to 12 weeks)

  • Treatment Acceptability

    Average Insomnia Treatment Acceptability Scale (ITAS) scores, overall and by group. Total score for each subscale is the average of the 8 items, with higher scores indicating greater willingness to utilize the treatment.

    End of Treatment

  • Retention

    Percent of subjects who complete the study, overall and by group.

    Baseline to End of Treatment (Up to 12 weeks)

Study Arms (4)

Four Sessions of CBT-I

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy for Insomnia

Eight Sessions of CBT-I

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy for Insomnia

Ten Sessions of CBT-I

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy for Insomnia

Twelve Sessions of CBT-I

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

Cognitive behavioral treatment of insomnia

Also known as: CBT-I
Eight Sessions of CBT-IFour Sessions of CBT-ITen Sessions of CBT-ITwelve Sessions of CBT-I

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of organ-confined BC;
  • Treatment with RT;
  • Willingness and ability to provide informed consent;
  • They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
  • and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).

You may not qualify if:

  • History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG;
  • History of narcolepsy;
  • Night shift work;
  • Distant metastatic disease at presentation;
  • Active alcohol and/or drug dependence;
  • They do not have a diagnosis of BC;
  • They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
  • They have a current diagnosis of significant medical and/or psychiatric disorders;
  • And/or they are not between the ages of 25-85 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersNeoplasmsFatigue

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Behavioral Sleep Medicine Program

Study Record Dates

First Submitted

December 7, 2021

First Posted

February 7, 2022

Study Start

March 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)