Pilot Telehealth Weight Loss Program for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
研究概览
简要总结
This is a single-arm longitudinal group to examine patient-reported outcomes, body mass and mammographic density changes pre- and post- weight loss intervention of breast cancer survivors using video conferencing telehealth visits.
详细描述
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. These group sessions, with 6 participants per group, will be delivered virtually via a HIPAA Compliant Teleconference Platform. The expected number of participants is at least 2 and no more than 6 in this 90-min group sessions which will be provided by a counselor from Penn Center for Weight and Eating Disorders.
The content of the sessions addresses the domains associated with behavioral weight management, including nutrition, exercise, stress and emotion management, and lifestyle modification strategies (to improve adherence to the diet and activity plan). Participants will monitor energy intake and physical activity daily to help them achieve recommended calorie and activity goals. Self-monitoring will be encouraged online with MyFitnessPal.com, which will be shared with the study staff to increase accountability and provide opportunity for feedback to participants.
Each participant will also be mailed a digital scale so they can weigh themselves each week and report their weight to the group leader. Participants will be encouraged to start with at least 10 minutes of moderately vigorous physical activity (e.g., brisk walking, swimming), at least five days per week, building up to at least 30 minutes per day (150 minutes per week) by week 6.
The primary objective is to assess feasibility and acceptance of telehealth weight loss intervention by the participants. The participants will be asked to complete the following surveys at two time points: baseline (pre-) and treatment end (at week 24). The participants will complete the following psychosocial measures.
- City of Hope Quality of Life (COH-QOL) Instrument - Breast Cancer Patient (QOL-BC)
- The International Physical Activity Questionnaire (IPAQ) Short Form - that assess the types and intensity of physical activity and sitting time in which people routinely engage. It provides an estimate of total physical activity in MET-min/week and time spent sitting.
- Patient Health Questionnaire (PHQ-9) (Depression)
- Acceptability of Intervention Measure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
12 patients (and possibly up to 20) (2 telehealth groups with at least 6 participants; 1 group leader per group)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of in situ or invasive breast cancer
- •Have completed breast cancer surgery, adjuvant cytotoxic chemotherapy (as indicated) and adjuvant radiation therapy (as indicated) at least 6-months prior to enrollment
- •Not on active treatment for other cancer for at least 6-months prior to enrollment
- •Currently cancer free
- •Overweight or obese (BMI of 25 kg/m^2 or greater)
- •Have internet access and videoconferencing capability
排除标准
- •Current use of weight loss medication (OTC or prescription) or participation in behavioral weight loss program
- •Currently participating in a behavioral weight loss program
- •Self-report of alcohol or substance abuse within the past 12-months, including at-risk drinking (current consumption of more than 14 drinks per week)
- •Undergone bilateral mastectomy
- •History of Bulimia nervosa
- •Inability to provide informed consent
研究组 & 干预措施
Single-Arms Longitudinal Group
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.
干预措施: Behavioral Weight-Loss Program Via Telehealth - Weight Measures (Behavioral)
Single-Arms Longitudinal Group
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.
干预措施: Behavioral Weight-loss Program Via Telehealth (Behavioral)
Single-Arms Longitudinal Group
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.
干预措施: Validated Surveys of Patient-Reported Outcomes (Behavioral)
结局指标
主要结局
Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the City of Hope Quality of Life Instrument (COH-QOL) - Breast Cancer Patient (QOL-BC) at two time points: baseline (pre-) and treatment end (at week 24). * COH-QOL Instrument - Breast Cancer Patient (QOL-BC) - 46 items * The scoring is based on a scale of 0 = worst outcome to 10 = best outcome. Some items have reverse anchors and the value should be scored as the reverse of the item circled, e.g., if a patient selected "4" then their score on a reverse anchor would be 10 - 4 = 6.
Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the International Physical Activity Questionnaire (IPAQ) at two time points: baseline (pre-) and treatment end (at week 24). * The International Physical Activity Questionnaire (IPAQ) Short Form * This is an open-ended questionnaire surrounding individuals' last 7-day recall of physical activity.
Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Patient Health Questionnaire (PHQ-9) (Depression) at two time points: baseline (pre-) and treatment end (at week 24). \- The PHQ-9 is a nine item questionnaire and the scoring is based on a scale of 0= best outcome to 3 = worst outcome. Total scores range from 0 to 27 and higher scores are associated with higher severities of depression, ranging from minimal to severe.
Using the Acceptability of Intervention Measure to Assess Acceptability and Feasibility
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Acceptability of Intervention Measure at two time points: baseline (pre-) and treatment end (at week 24). \- The Acceptability of Intervention Measure is a four item questionnaire and the scoring is based on a scale ranging from 1 = completely disagree to 5= Completely Agree. Higher scores are associated with greater acceptability of the intervention.
Requesting Direct Verbal Feedback From Participants to Assess Elements of the Program that Work Well, to Acquire Suggestions, and to Seek Suggestions to Determine Feasibility and Acceptability
时间窗: 24 weeks
Finally, investigators will conduct an exit interview with each participant to assess the acceptability of the intervention, the delivery of the intervention via telehealth, and their satisfaction with their treatment outcomes. Investigators will also solicit suggestions for improvements to the program for future interventions.
Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the City of Hope Quality of Life Instrument (COH-QOL) - Breast Cancer Patient (QOL-BC) at two time points: baseline (pre-) and treatment end (at week 24). * COH-QOL Instrument - Breast Cancer Patient (QOL-BC) - 46 items * The scoring is based on a scale of 0 = worst outcome to 10 = best outcome. Some items have reverse anchors and the value should be scored as the reverse of the item circled, e.g., if a patient selected "4" then their score on a reverse anchor would be 10 - 4 = 6.
Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the International Physical Activity Questionnaire (IPAQ) at two time points: baseline (pre-) and treatment end (at week 24). * The International Physical Activity Questionnaire (IPAQ) Short Form * This is an open-ended questionnaire surrounding individuals' last 7-day recall of physical activity.
Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Patient Health Questionnaire (PHQ-9) (Depression) at two time points: baseline (pre-) and treatment end (at week 24). \- The PHQ-9 is a nine item questionnaire and the scoring is based on a scale of 0= best outcome to 3 = worst outcome. Total scores range from 0 to 27 and higher scores are associated with higher severities of depression, ranging from minimal to severe.
Using the Acceptability of Intervention Measure to Assess Acceptability and Feasibility
时间窗: 24 weeks
To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Acceptability of Intervention Measure at two time points: baseline (pre-) and treatment end (at week 24). \- The Acceptability of Intervention Measure is a four item questionnaire and the scoring is based on a scale ranging from 1 = completely disagree to 5= Completely Agree. Higher scores are associated with greater acceptability of the intervention.
Requesting Direct Verbal Feedback From Participants to Assess Elements of the Program that Work Well, to Acquire Suggestions, and to Seek Suggestions to Determine Feasibility and Acceptability
时间窗: 24 weeks
Finally, investigators will conduct an exit interview with each participant to assess the acceptability of the intervention, the delivery of the intervention via telehealth, and their satisfaction with their treatment outcomes. Investigators will also solicit suggestions for improvements to the program for future interventions.
次要结局
- To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density(24 Months)
- To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density(24 months)
- To measure changes from pre- to post-weight-loss intervention for 1) body mass.(24 Months)
研究者
Julia Tchou
Co-Director of the Rena Rowan Breast Center, Director of Breast Cancer Immuno-Oncology Research, Professor of Clinical Surgery, and Principal Investigator
Abramson Cancer Center at Penn Medicine