Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

Overseen By Daniel Hall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Sleep apnea, Epilepsy, Serious mental illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist cancer survivors struggling with chronic insomnia, which involves ongoing trouble sleeping. Participants will engage in a Survivorship Sleep Program, a form of Cognitive Behavioral Therapy for Insomnia, delivered either individually or in groups. Some will receive additional booster sessions to determine the most effective approach. The trial targets those who have completed their main cancer treatments but continue to face sleep issues. Participants should have a history of nonmetastatic cancer (cancer that hasn't spread widely) and experience chronic insomnia. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for improving sleep quality.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Cognitive Behavioral Therapy for Insomnia is safe for cancer survivors?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally safe and well-tolerated by cancer survivors. Studies have found that most people do not experience side effects from this treatment. Experts recommend it as the first choice for treating insomnia, and it has proven effective in reducing sleep problems among cancer survivors. The treatment includes online sessions, which are easy to use and convenient for patients. Overall, CBT-I is considered a safe way to manage insomnia in cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Survivorship Sleep Program (SSP) for cancer survivors because it offers a tailored approach to managing insomnia, which is often a significant issue for this group. Unlike standard treatments like medication or general cognitive behavioral therapy, SSP is specifically designed for cancer survivors and offers flexibility in delivery. Participants can choose between group or individual sessions, and some groups receive additional booster sessions to reinforce the benefits. This adaptability and focus on cancer survivorship make SSP a promising option for improving sleep quality and overall well-being in this population.

What evidence suggests that this trial's treatments could be effective for insomnia in cancer survivors?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively treats long-term sleep problems in cancer survivors. Studies have found that online CBT-I programs, such as the Survivorship Sleep Program (SSP), significantly improve sleep quality for these individuals. One study noted that CBT-I led to clear improvements in sleep and related symptoms. In this trial, participants will receive the SSP in different formats: some will have individual sessions, while others will participate in group sessions, with or without additional booster sessions. When provided online with support, the SSP is especially helpful for cancer survivors. Overall, this treatment shows promise in helping cancer survivors manage insomnia effectively. ^{2 3 6 7 8}

Who Is on the Research Team?

Daniel Hall, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who've finished their primary treatment and are struggling with chronic insomnia. Participants must have had nonmetastatic, localized, or regional solid or blood cancers and meet specific criteria for insomnia severity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Survivorship Sleep Program (SSP) with 4 weekly sessions, delivered either individually or in groups, followed by optional booster sessions.

4 weeks

4 virtual sessions

Booster Sessions

Participants receive 3 monthly booster sessions to reinforce the treatment effects.

12 weeks

3 virtual sessions

Follow-up

Participants are monitored for changes in insomnia severity, emotional distress, work-related functioning, and other sleep metrics.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship Sleep Program

Trial Overview

The study tests different ways to deliver a Survivorship Sleep Program using Cognitive Behavioral Therapy for Insomnia (CBT-I). It compares individual vs. group sessions, with some getting additional 'booster' sessions to see which method helps most with sleep issues.

How Is the Trial Designed?

Group I: Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions.

Group II: Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions.

Group III: Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.

Group IV: Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.

Survivorship Sleep Program is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Chronic insomnia in cancer survivors

Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia in cancer patients and survivors

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study involving 96 cancer survivors, higher levels of social support were linked to better adherence to cognitive-behavioral therapy for insomnia (CBT-I) and improved sleep outcomes, indicating that social support plays a crucial role in treatment success.

Both social support and CBT-I treatment independently contributed to reduced insomnia severity, suggesting that enhancing social support could be a valuable strategy to improve adherence and effectiveness of insomnia interventions in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. Kamen, C., Garland, SN., Heckler, CE., et al.[2020]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

The Sleep Treatment Education Program-1 (STEP-1) significantly reduced insomnia symptoms in cancer survivors, with mean Insomnia Severity Index scores dropping from 15.73 at baseline to 9.73 at one-month follow-up, indicating its potential efficacy as a treatment.

STEP-1 can be effectively delivered via videoconference, making it a more accessible option for cancer survivors who may face barriers to traditional therapy, thus improving their chances of receiving necessary insomnia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. Chevalier, LL., Fine, E., Sharma, A., et al.[2023]

Breast cancer survivors experience higher rates of insomnia, and a study involving 25 participants showed that a virtual assistant delivering cognitive behavioral therapy for insomnia (CBT-I) was perceived as feasible and acceptable for managing their sleep issues.

After testing the prototype, 79% of participants expressed interest in using the virtual assistant to track sleep patterns, and features like lifestyle modification and relaxation exercises were also well-received, indicating potential for broader application in similar high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Breast Cancer Survivors' Perceptions of Using Voice-Activated Technology to Address Insomnia: Feasibility Study Featuring Focus Groups and In-Depth Interviews. Arem, H., Scott, R., Greenberg, D., et al.[2020]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

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