STEP-YA for Sleep Disorders in Cancer Survivors

Overseen By STEP-YA Study Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Bipolar, Seizure disorder, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single online education session, with or without additional coaching, can help young adult cancer survivors improve their sleep. The treatment, called STEP-YA (Sleep Treatment Education Program for Young Adult Cancer Survivors), targets those who have had cancer and face significant sleep issues. Participants will receive either the educational session alone or the session plus two personalized coaching sessions. This trial suits cancer survivors aged 20-39 who have experienced sleep difficulties for at least a year and are not currently undergoing cancer treatment. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research focused on enhancing sleep health in young adult cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot change the use of any medications taken to help with insomnia during the study.

What prior data suggests that the STEP-YA program is safe for young adult cancer survivors?

Research shows that the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) aims to help young adult cancer survivors improve sleep through education. There are two versions: one with coaching and one without.

For STEP-YA with Coaching, studies have not identified any significant safety concerns. This version includes a 90-minute session with an instructor and focuses on understanding and managing sleep problems. It is mainly educational, making it low-risk and generally well-tolerated.

Similarly, STEP-YA without Coaching also emphasizes education. Research indicates that this version provides information on sleep issues and ways to improve them. Like the coaching version, it does not pose major safety risks.

Both versions of STEP-YA are educational and involve low-risk activities. Participants generally handle them well, with no negative effects reported in related studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEP-YA approach for sleep disorders in cancer survivors because it offers a personalized, accessible way to tackle sleep issues. Unlike traditional methods, which might include medications or in-person cognitive behavioral therapy, STEP-YA provides an online educational session that can be followed by remote coaching. This makes it easy for participants to engage with the program from home. The addition of individualized coaching sessions in one arm of the trial allows for a tailored experience, potentially enhancing the effectiveness of the treatment by addressing specific participant needs. This innovative approach aims to improve sleep quality without the drawbacks of medication, such as side effects or dependency.

What evidence suggests that this trial's treatments could be effective for sleep disorders in young adult cancer survivors?

Research shows that the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) can improve sleep problems in cancer survivors. Studies have found that similar programs using Cognitive Behavioral Therapy for Insomnia (CBTI) lead to significant and lasting improvements in sleep quality. In this trial, participants will receive either the STEP-YA version with coaching, offering personalized support that may enhance these benefits, or the version without coaching, which still provides useful information and tips for managing insomnia. Overall, STEP-YA has shown promise in helping young adult cancer survivors sleep better. ^{1 4 5 6 7}

Who Is on the Research Team?

Christopher Recklitis, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to read and write in English

Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.

I was diagnosed with cancer other than non-melanoma skin cancer over a year ago.

Exclusion Criteria

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

Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist

I have been diagnosed with Bipolar Disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a single online education session and complete baseline measures prior to randomization

1 session

1 online session

Coaching

Participants in the coaching condition receive 2 individualized remote coaching sessions

Up to 4 weeks

2 remote sessions

Follow-up

Participants complete follow-up questionnaires at 4 and 8 weeks post-baseline to assess insomnia severity and mood states

8 weeks

2 online follow-up assessments

Optional Follow-up

Participants may complete an additional insomnia severity assessment at 16 weeks post-intervention

16 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• STEP-YA with Coaching
• STEP-YA without Coaching

Trial Overview 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.

How Is the Trial Designed?

Group I: COACHING CONDITION STEP-YA Experimental Treatment 1 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-YA Active Control 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Nearly 47% of adolescents and young adults (AYA) who completed cancer treatment reported significant sleep disturbances, including long sleep onset times and insufficient sleep duration, indicating a high prevalence of poor sleep quality in this group.

There is a strong correlation between better sleep and improved quality of life for AYA cancer survivors, suggesting that addressing sleep issues could enhance overall well-being and potentially reduce the risk of insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Adolescents and Young Adults in the Year After Cancer Treatment. Daniel, LC., Aggarwal, R., Schwartz, LA.[2018]

A study involving 143 adolescent and young adult cancer survivors found that an 8-week physical activity therapy using intelligent wearable devices significantly improved sleep quality compared to routine care, with effects lasting for at least 3 months.

In contrast, internet-based modified behavioral activation therapy did not show a significant improvement in sleep quality compared to the control group, highlighting the superior efficacy of physical activity interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Two Interventions on Sleep Quality for Adolescent and Young Adult Cancer Survivors: A Pilot Randomized Controlled Trial. Li, L., Wang, L., Sun, Q., et al.[2022]

The AYA Can-Sleep programme aims to evaluate the feasibility and acceptability of a stepped-care cognitive behavioural therapy for insomnia (CBTi) approach for adolescents and young adults with cancer, targeting 80 participants aged 16-25.

This study will assess the effectiveness of initial self-management and coaching for sleep difficulties, with further individualized CBT offered if needed, contributing valuable insights into improving sleep health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AYA 'Can-Sleep' programme: protocol for a stepped-care, cognitive behavioural therapy-based approach to the management of sleep difficulties in adolescents and young adults with cancer. Vaughan, E., Ftanou, M., Lewin, J., et al.[2022]

Nearly half of the surveyed childhood cancer patients (576 participants) reported experiencing sleep disorders, with insomnia (9.6%) and circadian rhythm sleep disorder (8.1%) being the most common.

A significant number of patients (42-72%) expressed a desire for sleep treatment, yet only a small fraction (0-5.6%) actually received it, highlighting a critical gap in care and the need for better screening and treatment access post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Sleep Disorders, Risk Factors and Sleep Treatment Needs of Adolescents and Young Adult Childhood Cancer Patients in Follow-Up after Treatment. Peersmann, SHM., Grootenhuis, MA., van Straten, A., et al.[2022]

The STEP-YA program is a new online educational intervention designed to help young adult cancer survivors (YACS) improve their insomnia symptoms and mood, addressing their unique challenges after cancer treatment.

This phase 2 trial will assess the effectiveness of STEP-YA in 74 YACS with insomnia, comparing outcomes between those who receive additional coaching and those who do not, with results expected to inform future treatment strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. Michaud, AL., Bice, B., Miklos, E., et al.[2023]

Adolescent and young adult (AYA) cancer survivors (n=167) reported significantly more fatigue compared to controls (n=170), despite no differences in sleep quantity or quality between the two groups.

Sleep and fatigue problems in AYA cancer survivors were found to predict higher levels of depression, anxiety, and posttraumatic stress symptoms over time, highlighting the need for screening and addressing sleep issues to improve mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between sleep problems and psychological outcomes in adolescent and young adult cancer survivors and controls. Daniel, L., Kazak, AE., Li, Y., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38019571

Sleep Treatment Education Program for Young Adult Cancer ... Objective: In this phase 2 "proof of concept" trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in ...

2. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074824005882

Sleep Treatment Education Program for Cancer Survivors A systematic review found that CBTI given to cancer survivors “provides significant, lasting improvement” [19]. Even compared to pharmacotherapy, multiple ...

3. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10458886&term=CA261863

Division of Cancer Control & Population Sciences - Grant Details Delivered in a 90-minute, synchronous 1:1 session led by an instructor, STEP-YA explains causes of insomnia, introduces CBTI principles and methods, and ...

4. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/stepya

Are you a young adult cancer survivor and having trouble ... STEP-YA is a study for young adult cancer survivors who are experiencing insomnia (difficulty falling or staying asleep). Insomnia can be a problem for some ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06736548

Sleep Treatment Education Program for Cancer Survivors: ... This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program ...

6. researchprotocols.org researchprotocols.org/2024/1/e60762

Sleep Treatment Education Program for Cancer Survivors The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms.

7. dana-farber.org dana-farber.org/clinical-trials/21-613

Sleep Treatment Education Program for Young Adult ... The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult ...