Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Change in vegetable and fruit intake at 13-weeks in survivors
研究概览
简要总结
Fewer than 20% of Hispanic cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Diagnosed at younger ages, later stages and with fewer resources (e.g., access to care), Hispanic cancer survivors are more likely to suffer from many symptoms, which linger long after they have completed treatment and may prevent them from leading a healthy life. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This randomized controlled trial tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health.
详细描述
In the proposed randomized controlled trial, the investigators will test the 12-week SMLI against an attention control condition in 107 dyads of Hispanic cancer survivors who have completed curative treatments within the past two years and their informal caregivers. A 12-week follow-up will determine the sustainability of the intervention. The primary outcome of this trial, vegetable and fruit intake in survivors (secondary in caregivers), will be measured at baseline, 13, and 25 weeks, using validated methods. Additional secondary and exploratory outcomes will add to the rigor of the trial and provide robust findings for future dissemination efforts.
Specific Aim #1: Test the efficacy of the SMLI as compared to attention control among Hispanic female cancer survivors and their caregivers with respect to:
- Increase in fruit and vegetable consumption (measured via self-reported 24-hour recall and objectively with carotenoid skin colorimetry)
- Increase in physical activity (Metabolic Equivalents hours/week of moderate to vigorous physical activity measured by actigraphy) and decrease in symptom severity index
Specific Aim #2: Determine the extent to which improvements in primary and secondary outcomes over weeks 13 and 25 are mediated by social support and self-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for female Hispanic cancer survivors:
- •18 years of age or older;
- •have access to a telephone,
- •speak and understand English or Spanish;
- •have finished curative intent treatment for cancer within the previous 10 years and do not have any subsequent cancer treatments planned, except for non-curative intent maintenance therapy, such as hormonal therapy;
- •must have at least 1 of the 5 most common cancer-related symptoms (pain, sleep disturbance, anxiety, depression and/or fatigue) with a severity score of 4 or higher on a 0-10 rating scale (based on NCCN guidelines for symptom monitoring and management used successfully in past work); and
- •has a caregiver willing to participate in the study with them.
- •Inclusion criteria for the caregivers (nominated by the survivor) are:
- •age 18 or older;
- •able to speak and understand English or Spanish;
- •access to a telephone; and
- •not currently treated for cancer preserving the distinction between survivor and caregiver. The caregiver can be of any race or ethnicity and any gender.
排除标准
- •for survivors:
- •Under the age of 18 years
- •Does not have access to a telephone
- •Completed treatment for cancer more than 1 year ago
- •Currently receiving counseling or treatment for special diet or weight loss
- •Does not have a caregiver willing to participate with them
- •Exclusion criteria for caregivers:
- •Under the age of 18 years
- •Does not have access to a telephone
- •Currently receiving counseling or treatment for special diet or weight loss
- •Currently being treated for cancer
研究组 & 干预措施
Attention control
Dyads will receive mailed print education materials regarding healthy lifestyle (nutrition and physical activity) disseminated by ACS and NCI. They will also receive 12 weekly phone calls to assess post-treatment related symptoms.
干预措施: Symptom assessment only (Behavioral)
Symptom management and lifestyle intervention
Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.
干预措施: Symptom management and lifestyle intervention (Behavioral)
结局指标
主要结局
Change in vegetable and fruit intake at 13-weeks in survivors
时间窗: Baseline to 13-weeks
Measured using data from 24-hour dietary recalls conducted on three randomly chosen days per timepoint including one weekend day and two weekdays. Objective assessment will be conducted in 10% of the sample using the Veggie Meter® Skin Carotenoid Scanner which measures skin carotenoid levels.
Change from baseline vegetable and fruit intake at 25-weeks in survivors
时间窗: Baseline to 25-weeks
Measured using data from 24-hour dietary recalls conducted on three randomly chosen days per timepoint including one weekend day and two weekdays. Objective assessment will be conducted in 10% of the sample using the Veggie Meter® Skin Carotenoid Scanner which measures skin carotenoid levels.
次要结局
- Physical activity(Baseline, 13-weeks, and 25-weeks)
- Symptom severity(Baseline, 13-weeks, and 25-weeks)
- Vegetable and fruit intake in caregivers(Baseline, 13-weeks, and 25-weeks)