A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors (LEAN3)

Yale University

Status: Completed

Conditions: Breast Cancer Survivorship; Obesity

Treatments: Behavioral: LEAN book/videos

Study type: Interventional

Funder types: Other

Identifiers

NCT02681965

1410014716

Details and patient eligibility

About

Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).

Full description

The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.

The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.

Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.

Enrollment: 205 patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight individuals (BMI >= 25.0 kg/m2)
• Breast cancer survivors who have completed chemotherapy and/or radiation therapy
• Stage 0-III
• The ability to be physically able to exercise (e.g. walk at a moderate pace)
• Agree to random assignment to either group
• Give informed consent to participate in all study activities
• Accessible by telephone
• Able read and communicate in English

Exclusion criteria

• Pregnant or intending to become pregnant in the next year
• Recent (past 6 months) stroke or myocardial infarction
• Severe uncontrolled mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

LEAN

Experimental group

Description:

Participants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed.

Treatment:

Behavioral: LEAN book/videos

Waitlist Control

No Intervention group

Description:

Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet.