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Understanding Sleep Problems and Testing a Digital Sleep Support Program for Adolescent and Young Adult Cancer Survivors

Multidimensional Sleep Health in Adolescent and Young Adult Cancer Survivors: Associations with Cardiometabolic and Psychological Outcomes and Feasibility of a Digitally Delivered, Severity-Stratified, Multicomponent Behavioral Sleep Intervention - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/113154
Enrollment
150
Registered
2026-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Multicomponent Behavioral Sleep Intervention: Eligible participants will be screened using the Insomnia Severity Index, Hindi Version (ISI-H). Based on baseline ISI score and RU-SATED c
Week 1 sleep diary submitted
facilitator check-in conducted. Session 2 Behavioral Strategies (Week 2, via Google Meet) Both streams receive: Review of Week 1 sleep diary Relaxation techniques Progressive Muscle Relaxation
Week 2 sleep diary submitted
facilitator check-in conducted. Step 8: Session 3 Consolidation and Planning (Week 3, via Google Meet) Both streams receive: Review of overall sleep diary progress Collaboratively developed indiv

Sponsors

Dr Sameer Bakhshi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 15 to 39 years at the time of enrollment 2. Confirmed diagnosis of cancer of any type 3. At least 6 months post-treatment at the time of enrollment 4. Able to read and write in either English or Hindi 5.Have consented to participate 6. Insomnia Severity Index score of more than or equal to 12 and two or more domains impaired on RU SATED framework.

Exclusion criteria

Exclusion criteria: 1. prior attempts to treat insomnia using cognitive behavioural therapy for insomnia. 2. History of mood disorders or schizophrenia. 3. History of a seizure disorder diagnosis or seizure in the past 12 months 4. Intention to adjust use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period 5. Diagnosed, untreated sleep apnea or other sleep disorder 6. Employment involving irregular sleep patterns such as shift work or frequent long-distance travel across time zones 7. Refusal to modify or reduce excessive alcohol use likely to interfere with sleep

Design outcomes

Primary

MeasureTime frame
The primary outcome of the intervention study is feasibility, defined as the proportion of enrolled participants who successfully complete all three intervention sessions. The intervention will be considered feasible if 70 percent or more of enrolled participants complete all three sessions. A completion rate below 50 percent will be considered unacceptableTimepoint: 3 weeks

Secondary

MeasureTime frame
Acceptability will be assessed using context adapted client satisfaction questionnaire administered at the end of the intervention capturing participants appraisal of the intervention content, format, digital delivery, and perceived usefulness.Timepoint: 3 weeks;Longitudinal change in Insomnia Severity Index scores at baseline, 3 months, and 6 months.Timepoint: 3 weeks, 3 months, 6 months;Longitudinal change in PSQI global scores and RU SATED composite scores at baseline, 3 months, and 6 monthsTimepoint: 3 weeks, 3 months and 6 months;Longitudinal change in DASS-21 subscale scores at baseline, 3 months, and 6 months.Timepoint: 3 weeks, 3 months and 6 months;Change in actigraphy-derived Total Sleep Time, Sleep Efficiency, Sleep Onset Latency, and Wake After Sleep Onset .Timepoint: across the three-week intervention period

Countries

India

Contacts

Public ContactSameer Bakhshi

AIIMS New Delhi

sambakh@hotmail.com09958828763

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026