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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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 cancer survivors' (YACS) sleep. The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).

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 data supports the effectiveness of the STEP-YA treatment for sleep disorders in young adult cancer survivors?

The STEP-YA treatment is based on cognitive behavioral therapy for insomnia (CBTi), which is considered the best treatment for sleep problems and has shown improvements in insomnia, daytime sleepiness, fatigue, and quality of life in adolescents and young adults with cancer. ^{1 2 3 4 5}

Is the STEP-YA program safe for young adult cancer survivors?

The STEP-YA program, which is a low-intensity educational intervention delivered online, is based on cognitive behavioral therapy for insomnia (CBTI), a well-established and safe treatment for sleep issues. While specific safety data for STEP-YA is not detailed, CBTI is generally considered safe for improving sleep quality in young adult cancer survivors. ^{1 2 4 5 6}

How is the STEP-YA treatment different from other treatments for sleep disorders in young adult cancer survivors?

STEP-YA is unique because it is a low-intensity educational program delivered online, specifically designed to address the developmental and circadian challenges of young adult cancer survivors, making it more accessible than traditional cognitive behavioral therapy for insomnia (CBTI), which often faces barriers like provider shortages and geographic limitations. ^{1 2 3 5 6}

Research Team

Christopher Recklitis, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep in Adolescents and Young Adults in the Year After Cancer Treatment. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Relationship between sleep problems and psychological outcomes in adolescent and young adult cancer survivors and controls. [2018]

4. Switzerland 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. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Two Interventions on Sleep Quality for Adolescent and Young Adult Cancer Survivors: A Pilot Randomized Controlled Trial. [2022]