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STEP-YA for Sleep Disorders in Cancer Survivors

N/A

Recruiting

Led By Christopher J Recklitis, PhD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned

Age 20-39

Must not have

Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea

Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks post-intervention session

Awards & highlights

No Placebo-Only Group

Summary

This trial is exploring if an online education session on sleep, with or without coaching, can help improve the sleep of young adult cancer survivors. The name of the study is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

Who is the study for?

This trial is for young adult cancer survivors aged 20-39 who have been cancer-free and off active therapy for at least four months. They must be experiencing significant insomnia, able to read/write in English, and diagnosed with cancer over a year ago. Exclusions include bipolar or seizure disorders, untreated sleep apnea, irregular sleep patterns due to work, recent insomnia treatments, or plans to change medications affecting sleep.

What is being tested?

The STEP-YA program aims to improve the sleep of young adult cancer survivors through an online education session. The study compares the effectiveness of this session alone versus the session combined with individualized coaching sessions.

What are the potential side effects?

As STEP-YA involves educational content and possibly coaching sessions without medication or invasive procedures, no direct side effects are expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had cancer treatment in the last 4 months and don't plan to have more.

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I am between 20 and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sleep apnea but am not getting treatment for it.

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I do not have any impairments that prevent me from completing study tasks on my own.

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I have been diagnosed with a seizure disorder or had a seizure in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks post-intervention session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks post-intervention session

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks post-intervention session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Change at 8 Weeks

Secondary study objectives

Insomnia Severity Change at 4 weeks

Profile of Mood States Change at 4 weeks

Profile of Mood States Change at 8 weeks

Other study objectives

Final satisfaction with the intervention

Initial Satisfaction with Intervention Session

Insomnia Severity at 16 weeks (optional)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: COACHING CONDITION STEP-YAExperimental Treatment1 Intervention

Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.

Group II: NON-COACHING CONDITION STEP-YAActive Control1 Intervention

Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.

0 / 5Eligibility criteria met