A Dyad-based Multiple Behavior Intervention for Reducing Lung Cancer Symptoms - a Pilot Randomized Control Trial (Breathe Easier II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the symptom of dyspnea
研究概览
简要总结
This pilot randomized control trial (RCT) will test a 12-week, multiple behavior intervention physical activity and stress management for survivors with early stage lung cancer (stages I-III) and their family members (1 survivor + 1 family member or friend = 1 dyad). The long-term goal of this research is to improve health outcomes for survivors of lung cancer and their family members.
The goals of the intervention, Breathe Easier, are symptom reduction (less breathlessness, less fatigue, less stress) and change in multiple behaviors (increase in stress management and increase in physical activity, and decrease tobacco use - if appropriate).
Our aim is: To conduct a 6-month, two-group, pilot randomized control trial intervention study with a pre- and post-test study design to estimate preliminary intervention effects on (a) reduction of symptoms (breathlessness, fatigue, and stress) in survivors of non small cell lung cancer (stages I-III) and family members or friends; (b) increase in physical activity behaviors immediately following the intervention and at 3-months; (c) increase in stress management strategies immediately following the intervention and at 3-months; (d) reduction in smoking behavior among participants who smoke tobacco products at study entry immediately following the intervention at 3-months.
详细描述
Lung cancer is the second most diagnosed malignancy and the leading cause of cancer deaths, accounting for more annual deaths than breast, prostate, and colorectal cancer combined. Approximately 80% will be diagnosed with NSCLC, and about 42.1% will present with early-stage or localized disease (stages I-III). Improvements in screening and treatment have led to better outcomes for early-stage diagnoses. As early detection improves along with treatments, the current 5-year survival rates (57%, stages I-III; 70%, stage I) are projected to improve.
Only a small percentage (5-10%) of patients with lung cancer are asymptomatic at diagnosis. Cough, dyspnea, chest discomfort, and fatigue are common symptoms. Up to 80% of long-term lung cancer survivors report smoking-related comorbidities such as chronic obstructive pulmonary disease (COPD) and heart disease. Thoracic surgery, radiation and chemotherapy may improve or worsen symptoms. After curative surgery, survivors describe persistent physical and psychological symptoms negatively affecting their QOL. The extent of the resection, co-morbid conditions, and smoking status further exacerbate symptoms. Symptoms may be intensified by smoking or withdrawal from tobacco. Nicotine withdrawal brings about a variety of physical and psychological symptoms that can temporarily intensify the symptom burden. Overall, survivors with lung cancer experience more symptom distress than survivors with other types of cancer.
Multiple unhealthy behaviors often accompany smoking, including lower physical activity levels and ineffective stress-management skills. Researchers have examined the prevalence of multiple health behaviors in lung cancer survivors; four studies targeted dyads. In one cross-sectional study data from 37 dyads (mostly white, non-Hispanic) showed high rates of smoking (43%, survivors; 30%, family members (FMs)) and physical inactivity (84%, each group). In terms of readiness to change, within 6 months post-diagnosis, 63% of patients and 81% of FMs were ready to increase their physical activity, and 88% of patients and 91% of FMs were prepared to stop smoking. A qualitative study involving 26 African American dyads, within 7 years post-diagnosis, revealed fewer current smokers (15%, survivors; 8% FMs) and persistent physical inactivity (65% survivors; 42% FMs). Two more recent studies collected similar data from survivors and their caregivers (mostly white, non-Hispanic) within 1-month post-diagnosis and 6-months post thoracic surgery reported that survivors and caregivers were receptive to educational and lifestyle behavior modification programs.
Evidence strongly suggests that smoking cessation and physical exercise interventions (individually administered) improve QOL and other outcomes; furthermore, exercise therapy is a well-tolerated, safe, and feasible adjunct therapy that can mitigate several diseases- and treatment-related side effects. Mounting evidence suggests that survivors with early-stage lung cancer benefit from regular physical activity. In a study of 175 long-term lung cancer survivors, the 27% who reported meeting physical activity guidelines also reported a higher QOL. Two pilot studies provided "proof of principle" and showed aerobic training (continuous activity involving large muscle groups) is safe and feasible for survivors of early-stage lung cancer. Thus, it is hoped that this research will advance scientific knowledge about these behaviors being complementary and producing a synergistic effect on behavior change and symptom management.
Family, friends, and especially partners of survivors of lung cancer must cope with its physical and psychological impact on the survivor, themselves, and others. It is important to recognize that survivors and their family members react to a serious illness as a unit, and as a result they both have a genuine need for help from healthcare providers. Partners not only provide emotional and practical support, but they must also cope with their own concerns, including the uncertainty surrounding the course of the illness, fear of losing their partner and the impact of their health behaviors. More than half of the partners of lung cancer survivors report negative emotional effects of being the support person. Relationships between survivors and partners are affected by the cancer also. An emerging consensus in the literature is that when both the survivor and family member are treated simultaneously, the well-being of each individual improves. When their needs are not addressed, family members are at risk for impaired health. Interestingly, most health behavior-related interventions focus on an individual's behaviors. Yet, health behaviors tend to cluster in families and social networks. The past decade has seen a growth in interventions exploring the effects of family members (and their behaviors) on each other when a serious illness is diagnosed in one of them. A greater emphasis is needed on interventions that target families, not only the survivor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
One staff person who is the outcome assessor will be blinded to group assignment.
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vulnerable populations: Three groups (prisoners, pregnant women and unborn fetuses, and children) will not be included in this study because there may be unknown risks. Prisoners will be excluded because if a survivor or a family member were a current prisoner, it would be impractical to expect an individual to fully participate for 6 months.
- •Pregnant women and unborn fetuses will be excluded because there may be unknown risks.
- •Inclusion of adolescents and children: Adolescents and children will be excluded also because they are younger than the Inclusion Criteria requirement of 21 years of age. Strategies to obtain representation of children in this study would not be appropriate, as they do not get the disease. Also, they will be excluded from participating as family members.
- •Inclusion and
排除标准
- •Inclusion Criteria: Survivors
- •Completed primary treatment for localized NSCLC (stages I-III). Survivors receiving adjuvant therapy are eligible.
- •Willing to use a cell phone capable of receiving text messages
- •Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
- •Willing to consider behavior change at this time
- •A family member or friend is willing to participate who is at least 21 years old
- •Able to speak and read English
- •Capable of informed consent
- •A health clearance form is signed by a health care provider prior to enrollment
- •Inclusion Criteria: Family Members or Friends
- •Willing to use a cell phone capable of receiving text messages
- •Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
- •Willing to consider behavior change at this time
- •Has an eligible family member willing to participate who is at least 21 years old
- •Able to speak and read English
- •Capable of informed consent
- •A health clearance form signed by a health care provider prior to enrollment
- •Exclusion Criteria: Both
- •A known diagnosis of advanced lung cancer (stage IV)
- •Physical activity is not recommended
- •A history of recurrent falls
- •A substantial mobility impairment related to rheumatoid arthritis, cerebral palsy, muscular dystrophy, multiple sclerosis, paralysis, Parkinson's disease, stroke
研究组 & 干预措施
Attention Control
- Education: Each survivor will receive a copy of "Facing Forward; Life After Cancer Treatment" (No. 18-2424, March 2018). Each family member or friend will receive "When Someone You Love is Being Treated for Cancer" (No. 14-5726, May 2014). Specific parts of booklets will be reviewed during the 15-minute/per participant telephone "chat".
- Telephone "Chats": The primary purpose is study retention. After the first 12-week period ends the weekly chats will be tapered for 12 weeks.
- One text message delivered weekly by telephone is a reminder of the day and time of the chat(s).
Tobacco Use Reduction: Many survivors of lung cancer struggle with nicotine addiction; smoking cessation and relapse prevention content will be made available to current smokers (The FOREVER FREE program - a free, twelve short booklet evidence-based resource created by the H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida).
干预措施: Breathe Easier (Behavioral)
BE Intervention Group
- The BE Manual is an educational resource for Managing Stress, Increasing Physical Activity (PA) and Stopping Smoking and Staying Smoke free.
- A timed, weekly telephone counseling session (60 min./dyad max) will be recorded. The purpose is to provide social support with SMART goal setting, adherence monitoring, encouragement..
- Breathing Exercises and Meditations are incorporated into the BE Manual and sent by a link via text messages.
- A Texting Library provides additional education, support, and encouragement daily. There are 5 story lines: BE Active, BE Kind to Yourself, BE Supportive and BE Smoke free (offered to current smokers only). Stay Smoke free will be instituted once tobacco use has stopped.
- Weekly Logs for tracking goals and progress with behavior changes (PA, breathing practices and meditations) and a pedometer are provided. After 12 weeks, the calls and texts will be tapered.
干预措施: Breathe Easier (Behavioral)
结局指标
主要结局
Change in the symptom of dyspnea
时间窗: Pre-intervention (Baseline) and post 6-months
As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1) Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.
Physical function behavior change
时间窗: Pre-intervention (Baseline) and post 6-months
Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).
Stress management behavior change
时间窗: Daily for 6 months
Measured by self-reported practice of breathing exercises documented on daily logs.
Change in perceived stress
时间窗: Pre-intervention (Baseline) and post 6-months
As measured by a validated instrument: Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.
Change in the symptom of breathlessness
时间窗: Pre-intervention (Baseline) and post 6-months
As measured by validated instrument: Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability. 1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.
Change in the symptom of fatigue
时间窗: Pre-intervention (Baseline) and post 6-months
As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue. Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.
Physical function behavior change
时间窗: Daily for 6 months
Measured by self-reported step counting using a pedometer and documented on a daily log.
Physical function behavior change
时间窗: Pre-intervention (Baseline) and post 3-months
Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).
Change in the symptom of dyspnea
时间窗: Pre-intervention (Baseline) and post 3-months
As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1) Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.
Change in the symptom of breathlessness
时间窗: Pre-intervention (Baseline) and post 3-months
As measured by validated instrument: Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability. 1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.
Change in the symptom of fatigue
时间窗: Pre-intervention (Baseline) and post 3-months
As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue. Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.
Change in perceived stress
时间窗: Pre-intervention (Baseline) and post 3-months
As measured by a validated instrument: Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.
次要结局
- Tobacco use abstinence(Pre-intervention (Baseline) and post 6-months)
- Tobacco use abstinence(Pre-intervention (Baseline) and post 3-months)
- Tobacco use abstinence(Pre-intervention (Baseline) and post 3-month)
研究者
Karen Kane McDonnell
Associate Professor
University of South Carolina
