Clinical trial NCT02681965: A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors
Official title: A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivorship
Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kg)
timeFrame: 6 Months
Secondary outcomes:
measure: Body weight (kg)
timeFrame: Baseline
measure: Body weight (kg)
timeFrame: 12 Months
measure: Quality of Life (QOL)
timeFrame: Baseline
measure: Quality of Life (QOL)
timeFrame: 6 months
measure: Dietary Intake
timeFrame: Baseline
measure: Dietary Intake
timeFrame: 6 months
measure: Dietary Intake
timeFrame: 12 months
measure: Physical Activity (Moderate)
timeFrame: Baseline
measure: Physical Activity (Moderate)
timeFrame: 6 months
measure: Physical Activity (Moderate)
timeFrame: 12 months
measure: Physical Activity (Vigorous)
timeFrame: Baseline
measure: Physical Activity (Vigorous)
timeFrame: 6 months
measure: Physical Activity (Vigorous)
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: MEPH Chronic Diseases, Yale School of Medicine
name: Yale School of Medicine Irwin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: