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Telehealth Weight Loss Program for Breast Cancer Survivors (TWL Trial)
N/A
Recruiting
Led By Julia C Tchou, MD, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial is looking at how well a weight-loss intervention works for breast cancer survivors, using video conferencing for visits.
Eligible Conditions
- Breast Cancer
- Obesity
- Cancer Survivors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity
Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression
+2 moreSecondary outcome measures
To measure changes from pre- to post-weight-loss intervention for 1) body mass.
To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density
To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-Arms Longitudinal GroupExperimental Treatment3 Interventions
Behavioral weight-loss program via telehealth (video conferencing). Participants will receive weekly group sessions of lifestyle counseling for the first 20-weeks, followed by every other week sessions in weeks 22 and 24, for a total of 6-months of intervention.
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,901 Total Patients Enrolled
41 Trials studying Breast Cancer
35,313 Patients Enrolled for Breast Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
396 Previous Clinical Trials
147,946 Total Patients Enrolled
44 Trials studying Breast Cancer
60,829 Patients Enrolled for Breast Cancer
Julia C Tchou, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have reported excessive drinking or drug abuse in the last 12 months.You have a history of bulimia nervosa.The patient must not have been receiving active treatment for any other form of cancer for at least six months prior to enrollment in the study.The requester needs access to the internet and the ability to videoconference.You are currently using weight loss medication or participating in a weight loss program.!
I am currently cancer free.people are likely to die sooner than those of normal weight, with the exception of those who are severely obese (BMI of 40 kg/m^2 or greater)You have had both breasts removed by surgery.You are currently enrolled in a program to lose weight through behavior modification.
Research Study Groups:
This trial has the following groups:- Group 1: Single-Arms Longitudinal Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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