Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
研究概览
简要总结
The goal of this study is to understand whether providing a structured survivorship care visit at the beginning of cancer treatment is associated with changes in distress and quality of life in adults with cancer receiving treatment in a community oncology clinic. The main questions it aims to answer are:
- Is participation in a structured survivorship visit at the start of active treatment associated with changes in psychological distress?
- Is participation in the survivorship visit associated with changes in quality of life?
Participants will:
- Be asked to complete questionnaires about their level of distress and overall quality of life.
- Participate in a single survivorship visit with the clinic's Physician Assistant at the Ellis Medical Oncology Clinic.
- Complete the same questionnaires again approximately two weeks and one month after the survivorship visit.
详细描述
Psychological distress is common among individuals with cancer, and many patients experience emotional, social, physical, and practical challenges throughout treatment. Despite the high prevalence of distress, psychosocial needs often go unrecognized or inadequately addressed in routine oncology care. Unmet psychosocial needs have been associated with poorer quality of life, increased symptom burden, and difficulties coping with cancer and its treatment.
Survivorship care may represent one approach to addressing these needs. Cancer survivorship care focuses on the ongoing physical, emotional, and psychosocial effects of cancer and is designed to promote overall well-being and quality of life. Traditionally, survivorship care has been delivered after completion of active treatment. However, active treatment is often one of the most physically and emotionally demanding phases of the cancer journey. Providing survivorship care earlier may allow concerns to be identified and addressed as they arise rather than waiting until treatment has ended.
This single-arm pilot study aims to evaluate the feasibility and preliminary impact of a structured survivorship visit for patients experiencing clinically significant distress in a community oncology clinic. Patients with a score of ≥4 on the NCCN Distress Thermometer who express interest in participating will be offered a survivorship visit guided by their Distress Thermometer and Problem List responses. 15 adult patients will participate in this pilot. Changes in psychological distress and quality of life will be assessed using the NCCN Distress Thermometer and the Functional Assessment of Cancer Therapy-General (FACT-G) before and after the survivorship visit to explore whether this brief, structured intervention may be associated with improvements in distress and quality of life. Findings from this study will help inform the development of future studies evaluating the role of early survivorship care in improving psychosocial outcomes and quality of life among patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must fulfill all the following criteria to be included in the study:
- •Age 18 years and older.
- •Patients with histologically confirmed malignancy, any stage or type.
- •Beginning active therapy (either in oral or IV) for cancer at Ellis Medicine/Roswell Park Medical Oncology.
- •A score of ≥4 on the NCCN Distress Thermometer at screening.
- •Able and willing to provide written informed consent.
- •Ability to read and understand English sufficiently to complete study questionnaires.
排除标准
- •Patients with one or more of the following criteria will be excluded from the study:
- •Under the age of 18 years.
- •Patient is unable to provide informed consent.
- •Currently receiving ongoing therapy or have had treatment for cancer in the past (i.e., not a new start)
- •Significant cognitive impairment that would preclude completion of study questionnaires
研究组 & 干预措施
Survivorship Visit Intervention
Participants will receive a single structured survivorship visit during active cancer treatment. The visit will be guided by responses to the NCCN Distress Thermometer and Problem List and will address physical, emotional, social, practical, and spiritual concerns identified during distress screening.
干预措施: Structured Survivorship Visit (Behavioral)
结局指标
主要结局
Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
时间窗: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
Psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer and Problem List, a validated self-report measure in which participants rate their overall distress on a scale from 0 (no distress) to 10 (extreme distress). Change in distress scores from baseline to follow-up assessments will be evaluated.
次要结局
- Change in Quality of Life as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G)(Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit)
研究者
Dr.Tallat Mahmood,MD
Medical Oncologist
Ellis Medicine