Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)
研究概览
简要总结
This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.
详细描述
PRIMARY OBJECTIVES:
I. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors (LEF-self-care program [SCP]) with the goal of improving LEF associated outcomes when compared to usual care alone. (Stage I)
II. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction. (Stage II)
III. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and adherence compared to usual care in HNC survivors with LEF. (Stage II)
IV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and 3) functional status. (Stage II)
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post HNC primary treatment
- •No evidence of cancer (NED)
- •No more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema
- •> 18 years of age
- •Ability to understand English in order to complete questionnaires
- •Able to complete the onsite training and home self-care activities for LEF management
- •Able to provide informed consent
排除标准
- •Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
结局指标
主要结局
Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)
时间窗: Following 3 weeks of the LEF-SCP sessions
Feasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.
Feasibility of the LEF-SCP (Motivational Interviewing Sessions)
时间窗: Following 3 weeks of motivational interviewing sessions
Feasibility of the LEF-SCP was evaluated by number of participants that completed the motivational interviewing sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.
Preliminary Efficacy of the LEF-SCP (Symptom Burden)
时间窗: at 12 months post-intervention
Change in symptom burden score from baseline to 12 months post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (soft tissue and neurologic toxicity) score is reported here.
Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)
时间窗: at 12 months post-intervention
Change in total severity of external LEF from baseline to 12 months post-intervention. A larger change in this score means more reduction in the severity of external LEF, External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).
Preliminary Efficacy of the LEF-SCP (Self-Efficacy)
时间窗: at 12 months post-intervention
Change in self-efficacy score from baseline to 12 months post-intervention. A larger change in this score means increased self-efficacy. Self-efficacy is assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) (8-item). Higher scores (score ranging from 8-40) indicate greater self-efficacy.
次要结局
未报告次要终点
研究者
Jie Deng
Associate Professor
University of Pennsylvania