Health TrialsbyHealthPanel

Planning Grant for TOPS for Breast Cancer Survivors

ConditionsBreast CancerWeight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-90
SponsorDuke University

About this trial

The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.

This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.

The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.

This ClinicalTrials.gov record is specific to the second part of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Disqualifiers

Those whose oncology providers do not agree with their participation in a weight loss program

History of Type II Diabetes Mellitus

those participating in another weight loss program

those taking a weight loss medication

Trial design

Design model

Single group

Treatments tested in this trial

  • TOPS Classes

    Other intervention

    Attend Dietician-Led Sessions

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TOPS ClassesOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of invitations sent through the electronic health record to get 25 individuals consented to the study

Time frame
1-2 months
2

Percentage of TOPS group session attendance

This will be calculated as number of sessions attended divided by total number of sessions offered

Time frame
12 months
3

Number of participants who stay in the study

Time frame
3 months, 6 months, 9 months, 12 months
4

Number of participants who transition from the initiation phase to the maintenance phase

Time frame
12 months

Secondary outcomes

1

Cardiovascular Disease (CVD) risk factors as measured by blood pressure

Time frame
up to 12 months
2

Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c

Time frame
up to 12 months
3

Cardiovascular Disease (CVD) risk factors as measured by glucose

Time frame
up to 12 months
4

Percentage of participants who get blood drawn

Time frame
Baseline, 3 months, 6 months,12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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