• Share

PRINT

According to a study published by the Multinational Association of Supported Care in Cancer, sleep-related complaints are common among breast cancer survivors.

Studies have also shown that maintaining a normal weight can result in a reduced risk of cancer-related symptoms, including sleep problems, though data from published studies are not consistent. Additional studies have shown the possibility of an elevated risk of breast cancer among women who are obese.

So the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is conducting a pilot study to better understand the relationship between insomnia, weight loss and breast cancer.

More specifically, the study will examine the associations between body mass index (BMI) and sleep-related complaints in breast cancer survivors.

Education vs. therapy

Participants will be randomly placed in either of two groups. Both groups will start with a web- and phone-based program that promotes weight loss through a change of diet and activity levels.

For both groups, this phase includes 15 sessions over six months (one 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.

Then each group will have a different sleep intervention program. One will receive cognitive behavioral therapy (CBT) for insomnia. CBT is used to help people manage a variety of problems by changing the way they think and behave in response to them. The other group will receive a widely available sleep education program (without therapy).

For both groups, the sleep phase of the study includes six sessions over eight weeks (two in-person, followed by four phone or videoconferencing sessions).

Four in-person assessments will be coordinated with the in-person sleep and weight loss intervention visits. These will occur at the beginning of the study, and at two, three and six months into the study.

The primary outcome being examined is weight loss. Some of the measures that will be recorded throughout the study include height, weight, waist/hip measurements and sleep diaries.

A secondary outcome measure includes sleep continuity, measured by length of time between falling asleep and waking up. This will be measured using activity monitors and sleep diaries.

Here, the researchers will evaluate the extent to which improvements in short-term sleep continuity are associated with improvements in daily physical activity and dietary quality/quantity. They will see whether these improvements are also associated with three- and six-month weight changes.

Qualifying for the study

Study participants must be women who were diagnosed with early stage breast cancer between three months and five years ago, have a body mass index (BMI) greater than 25, and experience insomnia.

They must have a confirmed diagnosis of ductal carcinoma in-situ (DCIS) or stage I-III invasive carcinoma of the breast. They must also have completed treatment such as surgery, radiation and chemotherapy prior to enrollment.

Participants must weigh less than 400 pounds and be willing to lose 10 percent of their body weight. They must have been diagnosed with insomnia or report sleep problems, and have daily access to the Internet and/or a smartphone.

Compensation for time and travel may be available.

For more information, contact Alexandra Kearson at (410) 550-9056 or akearson1@jhmi.edu

.