A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 7/1/2018 |
| Start Date: | March 2016 |
| End Date: | April 1, 2018 |
A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
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).
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).
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.
(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.
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
We found this trial at
1
site
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
Click here to add this to my saved trials
