Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in 6 minute walk ability score
研究概览
简要总结
The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.
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
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I: Intervention Development and Refinement:
- •Inclusion Criteria:
- •Patients:
- •obese (BMI >30)
- •partnered
- •diagnosis of non-metastatic breast cancer (stages I-III)
- •completed adjuvant chemotherapy and/or radiation treatment in the last 5 years
- •healthy enough to participate in a home-based walking program (if participating in intervention refinement),
- •able to speak English
- •able and willing to give informed consent.
- •Partners:
- •Overweight/obese (BMI >25)
- •cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the last 5 years
- •healthy enough to participate in a home-based walking program (if participating in intervention refinement)
- •able to speak English
- •able and willing to give informed consent.
排除标准
- •for both patients and partners
- •male breast cancer survivors
- •non-ambulatory
- •unable to provide informed consent
- •have a major mental illness (i.e., schizophrenia);
- •have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- •reside > 100 miles from the research site.
- •Phase II: Feasibility, Acceptability, and Efficacy of the Intervention
- •Inclusion Criteria:
- •Patients:
- •Female, obese (BMI >30)
- •partnered
- •diagnosis of non-metastatic breast cancer (stages I-III)
- •completed adjuvant chemotherapy and/or radiation treatment in the last 3 years
- •healthy enough to participate in a home-based walking program
- •able to speak English
- •able and willing to give informed consent.
- •Partners:
- •Overweight/obese (BMI >25)
- •cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the three years
- •healthy enough to participate in a home-based walking program
- •able to speak English
- •able and willing to give informed consent.
- •Exclusion Criteria: for both patients and partners
- •male breast cancer survivors
- •non-ambulatory
- •unable to provide informed consent
- •have a major mental illness (i.e., schizophrenia)
- •have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- •reside > 100 miles from the research site.
- •Pregnant women will also be excluded from the study.
结局指标
主要结局
Change in 6 minute walk ability score
时间窗: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity.
Change in Promis Fatigue Scale
时间窗: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week
Change in Profile of Mood States (POMS)
时间窗: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days.
Change in Eating Behavior
时间窗: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual's usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month.
Change in eating behavior using the Three Factor Eating Questionnaire
时间窗: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.
Change in Stanford Leisure-Time Activity Categorical Item (L-Cat)
时间窗: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.
Change in Physical Activity based on the International Physical Activity Questionnaire
时间窗: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days.
Change in Weight
时间窗: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will be weighed at each assessment and each session.
Change in steps per day
时间窗: Through study completion (an average of 31 weeks)
Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study.
Change in 6 minute walk pain score
时间窗: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The degree of pain experienced during the 6-minute walk test will also be assessed.
Change in The Brief Pain Inventory (BPI)
时间窗: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.
次要结局
- Change in Heart Rate(Through study completion (an average of 31 weeks))
- Change in IL-6(baseline and 3 months post-treatment (approximately 30-32 weeks))
- Change in IL-8(baseline and 3 months post-treatment (approximately 30-32 weeks))
- Change in Fasting insulin(baseline and 3 months post-treatment (approximately 30-32 weeks))
- Change in TNF-alpha(baseline and 3 months post-treatment (approximately 30-32 weeks))
- Change in Self-Efficacy for Weight(pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18))
- Change in Adiponectin(baseline and 3 months post-treatment (approximately 30-32 weeks))
- Treatment Acceptability Questionnaire (TAQ)(post-treatment (approximately 30-32 weeks))
- Change in Session attendance rate(week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
- Change in Use of intervention strategies(week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
- Change in partner support for eating and exercise(pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks))
- Change in self-efficacy for managing chronic disease(pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18))