Improving Sleep, Fatigue, Activity & Quality of Life in Cancer Survivors Via a Transdiagnostic Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About this trial

Poor sleep affects over half of U.S. cancer survivors, contributing to daytime fatigue, reduced physical activity, and diminished quality of life. Traditional sleep treatments often target diagnosed disorders, leaving many survivors with subclinical sleep issues underserved. Sleep health-a broader concept encompassing sleep regularity, satisfaction, alertness, timing, efficiency, and duration (RU-SATED)-offers a more inclusive framework for intervention. The TSHI is a modular, skills-based program designed to improve these dimensions of sleep health. Delivered via six weekly one-on-one Zoom sessions, TSHI emphasizes behavioral strategies like sleep hygiene, relaxation, and energy management.

This six-week, single-group quasi-experimental pilot study will enroll 10 cancer survivors to assess the feasibility, acceptability, and preliminary effectiveness of TSHI. Researchers will evaluate changes in sleep health, fatigue, physical activity, and quality of life using surveys, interviews, and ActiGraph data. By targeting sleep as a modifiable health behavior, this study aims to lay the groundwork for scalable interventions that enhance recovery and well-being in cancer survivors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years old

≤7 on RU-SATED questionnaire

≥6 months removed from primary cancer treatment

able to speak/read English

Disqualifiers

≥15 on Patent Health Questionnaire 8

≥10 on Generalized Anxiety Disorder-7

self-reported current or recent history (≤2 years) of drug or alcohol abuse

history of nervous system disorder [e.g., stroke, Parkinson's disease, multiple sclerosis]

Trial design

Design model

Single group

Treatments tested in this trial

  • Transdiagnostic Sleep Health Intervention (TSHI)

    Behavioral

    A transdiagnostic sleep health intervention (TSHI) will be delivered across six weekly 50-minute one-on-one sessions with a sleep expert via a HIPAA-compliant videoconference link. The six weekly TSHI sessions are outlined as: Week 1: Consists of discussing sleep physiology and discussing appropriate bed and wake up times. Week 2: Consists of discussing how to set/importance of setting, a bedtime routine Week 3: Consists of discussing how to improve daytime function through energy management for daily and weekly tasks. Week 4: Consists of discussing the sleep beliefs the participant holds and possible corrections of any unhelpful sleep beliefs. Week 5: Consists of educating participants on sleep hygiene and how it is influenced by environmental, social, and physical factors. Week 6: Consists of discussing sleep behavior changes observed during the TSHI and collaborating with the participant on plans to maintain their new sleep pattern.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Sleep Health Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention

TSHI acceptability will be assessed qualitatively and quantitatively following the study. Qualitative assessments will involve semi-structured interviews with each participant, guided by a written list of questions. Quantitative assessments of TSHI acceptability, usability, and usefulness will use a modified System Usability Scale (SUS). scores range from 0-100 with a higher score indicating better perceived usability of the intervention.

Time frame
After study week 7
2

Recruitment

The investigators will assess program feasibility via recruitment. Recruitment rates will be: # of cancer survivors enrolled ÷ # of cancer survivors who complete the screening survey. With a higher number indicating ease, practicality, and efficiency of the recruitment process.

Time frame
After study week 7
3

Study Retention

We will assess program feasibility via study retention. Study retention will be: # of cancer survivors completing the TSHI ÷ # of cancer survivors who began the TSHI. A high retention rate indicates the ability to keep participants committed over time, suggesting that the project is feasible and likely to succeed.

Time frame
After study week 7
4

Adherence Rates

We will assess program feasibility via protocol adherence rates. Adherence will be: # of weekly videoconference-based TSHI sessions attended ÷ six (total number of TSHI sessions). A high adherence rate indicates that the study design is viable and participants are able and willing to follow the protocol.

Time frame
After study week 7

Secondary outcomes

1

Changes in Sleep Health constructs

Means and standard deviations will be calculated to evaluate the pre/post difference in the Regularity, Satisfaction, Alertness, Timing, Efficiency, and duration sleep health scale ( RU-SATED constructs). During the Baseline and Post-Study Testing Sessions, participants will complete the RU-SATED scale. This validated six-item scale assesses sleep regularity, satisfaction, alertness, timing, efficiency, and duration (i.e., RU-SATED). A scores range from 0-12 with a higher score indicating healthier sleep health.

Time frame
Baseline and After study week 6
2

Sleep Regularity

We will supplement RU-SATED construct measurements with sleep measurements made via the ActiGraph. Using the ActiGraph, Regularity will be assessed by the standard deviation of sleep midpoint, which is calculated as \[sleep onset+(wake-sleep inset/2)\]. The cut off for good sleep health is \<60 minutes

Time frame
Baseline and After Study week 6
3

Sleep Satisfaction

Using the sleep log, satisfaction will be assessed. The sleep log includes an item to rate "restedness upon awakening" with 0= " not at all", 1 "somewhat"., 2= "moderately", 3= " quite a bit", and 4 = " extremely". Satisfaction will be operationalized as the average "restedness" score. the cut off for good sleep ehalth is an average of ≥3

Time frame
Baseline and After Study week 6
4

Alertness

Using the Epworth Sleepiness Scale, Alertness will be measured. The Epworth Sleepiness Scale consists of 8-items of various activities (ie. Sitting and reading, watching TV, etc) answered using a 4-point Likert scale with 0+ " would never nod off" to 3= "high chance of nodding off". The cut off for food sleep health is ≤ 10.

Time frame
Baseline and After Study week 6

Other outcomes

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