Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Overweight

Breast Neoplasms

Weight Loss

Obesity

Body Weight

Sleep Initiation and Maintenance Disorders

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Cognitive behavioral therapy intervention for insomnia: 6 sessions over 8-week period combining education and behavioral techniques to reduce insomnia. Sleep intervention followed by behavioral weight loss intervention.

Program will parallel the CBT-I intervention in number and length of sessions. Intended to disseminate basic information about sleep, including behavioral treatment information that is widely available to patients and practitioners.Will be followed by behavioral weight loss intervention.

CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.

Cognitive Behavioral Therapy for Insomnia

EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.

Sleep Education

Janelle Coughlin, Ph.D.

This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.

Participants are women with a diagnosis of early stage breast cancer (ESBC), a BMI ≥25, and insomnia. A total of 30 participants will be randomized to either cognitive behavioral therapy for insomnia and behavioral weight loss (CBT-I+BWL) or a sleep education program and behavioral weight loss (EDU+BWL). Measures will be collected at baseline, 8 weeks (after the CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be % total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed.

The sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person, followed by 4 phone or videoconferencing sessions), and the BWL intervention includes 15 sessions over 6 months (1 in-person, 14 by phone or videoconference). Participants will be given physical activity trackers and will use a dietary app to record their food intake. There are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month follow up, 6-month follow up). These assessment visits are coordinated with in-person sleep and weight loss intervention visits. Some of the measures that will be recorded throughout the study include: height, weight, anthropometric measures (waist/hip measurements), sleep diaries, and self-report measures.

A total of 30 participants will be randomized to either cognitive-behavioral treatment for insomnia with behavioral weight loss (CBT-I+BWL) or a sleep education control condition with behavioral weight loss (EDU+BWL). The EDU group will have study sessions spread out in a similar fashion to the CBT-I group, and clinical outcomes will be compared between groups at baseline, 8 weeks (after the CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be % total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed.

Participants will not be blinded to the intervention assignment. However, data collection of anthropometric measurements (including height, weight, hip and waist circumference) will be done by a study member blinded to the randomization. Since participants will be aware of their intervention assignment, there are no anticipated circumstances for breaking the blinding or planned procedures for breaking the blinding.

Cancer, Obesity/Overweight and Insomnia Study

The Effects of Treating Insomnia Prior to a Weight Loss Intervention in Women With Early Stage Breast Cancer

The primary outcome will be percent (%) weight loss. All subjects who are randomized will be included in the analysis of the primary outcome. Weight will be measured according to standardized BMI and anthropometric procedures (hip/waist ratio). For the primary aim, comparing the effects of CBT-I+BWL and EDU+BWL on % weight loss at 3 and 6 months, we will model outcomes (at 3 months \& 6 mos.) as a function of baseline level, treatment assignment, time, and their interaction. The interaction term represents the between-group difference in change over time on the outcome.

WASO will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO.

TST will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO.

Sleep efficiency is measured as the ratio of total sleep time (TST) compared to the total time spent in bed (TST / time in bed). This is measured in percent of total time spent in bed, asleep.

Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months.

Sleep latency is the time it takes to transition from full wakefulness to sleep. This is measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months.

Under Armour

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting.

Katie Van Deventer, MD

UC Davis Comprehensive Cancer Center

Hui Chen, MD

The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.

Secondary objectives:

1. To compare insomnia symptoms before and after intervention.
2. To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. To evaluate the duration of symptoms improvement after the intervention is complete.

This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.

This is a pilot feasibility study looking at delivering small group therapy online.

Feasibility of Internet Group CBT-I for Gyn Oncology Patients

Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients

Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed.

A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable.

Measured by Insomnia Severity Index (ISI) with scale range of 0 to 27, higher numbers indicating more severe insomnia

Measured by the 7-item Functional Assessment of Cancer Therapy (FACT-G7) Assessment, with likhert scales from 0-4 and higher numbers indicating more severe symptoms

Measured by the Pittsburgh Sleep Quality Index (PSQI), score of 0-21 points, higher score indicating more severe difficulty sleeping.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer, Obesity/Overweight and Insomnia Study	NCT03542604	Breast Cancer Overweight and ... Insomnia	Cognitive Behav... Sleep Education	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cancer, Obesity/Overweight and Insomnia Study	NCT03542604	Breast Cancer Overweight and ... Insomnia	Cognitive Behav... Sleep Education	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Feasibility of Internet Group CBT-I for Gyn Oncology Patients	NCT06060158	Insomnia	Cognitive Behav...	18 Years -	University of California, Davis
Cancer, Obesity/Overweight and Insomnia Study	NCT03542604	Breast Cancer Overweight and ... Insomnia	Cognitive Behav... Sleep Education	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Feasibility of Internet Group CBT-I for Gyn Oncology Patients	NCT06060158	Insomnia	Cognitive Behav...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for cognitive behavioral therapy for insomnia