An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Feasibility: Enrollment Rate
研究概览
简要总结
The main purpose of this study is to field test and pilot an intervention called UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) that includes information about lymphoma survivorship and tools to improve quality of life and reduce lymphoma-related worries among lymphoma survivors.
详细描述
This is a two phase pilot study to develop and pilot the UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) program intervention that includes lymphoma survivorship information and acceptance and commitment therapy strategies to alleviate fear of cancer recurrence, reduce distress, and improve quality of life among lymphoma survivors.
Phase 1 will be a two-part development process of the UPLYFT program based on interview feedback from lymphoma and mental health clinicians and then feedback from a six-person group of lymphoma survivors after participation in an UPLYFT program field test. Phase 2 is a randomized pilot study using the UPLFYT program finalized in Phase 1.
Research procedures include:
- In depth interview (lymphoma and mental health clinicians)
- Screening for eligibility
- 6 weekly intervention sessions (lymphoma survivors)
- Baseline Assessments and Questionnaires (lymphoma survivors)
74 people are expected to participate in this study with 14 in Phase 1 and 60 in Phase 2.
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
- •Lymphoma Survivors Phase 1 and 2:
- •Diagnosis of lymphoma (indolent non-Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, or classic Hodgkin lymphoma)
- •Age ≥ 18 years
- •Interval of 3 months to 24 months from completion of first-line treatment
- •In complete remission after first line of treatment
- •Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale [FCRI-SS).
- •Access to computer (for videoconferencing)
- •Lymphoma clinicians and mental health clinicians Phase 1:
- •Lymphoma clinicians ≥ 1 year from oncology fellowship completion OR mental health clinicians (psychologists, social workers, psychiatrists) ≥ 1 year from completion of clinical training.
- •Longitudinal clinical care for patients with lymphoma by oncologists OR provision of care for patients with cancer by mental health clinicians
排除标准
- •Lymphoma Survivors Phase 1:
- •Age < 18 years
- •Concurrent other malignancy
- •Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorder (as ascertained from medical record screen).
- •Lymphoma Survivors Phase 2:
- •Age < 18 years
- •Concurrent other malignancy
- •Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorders (as ascertained from medical record screen).
- •Our study will exclude members of the following special populations:
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Clinicians Interviews
Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.
干预措施: Interview with Clinicians (Other)
Lymphoma Survivors Field Test
A six person group of lymphoma survivors will participate in a six session UPLYFT program field test to provide feedback for the development of the UPLYFT program.
干预措施: Field Test of UPLYFT with Lymphoma Survivors (Other)
UPLYFT Pilot
Lymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program.
Participants will be randomized 1:1 to either UPLYFT or usual care.
干预措施: Pilot of UPLYFT with Lymphoma Survivors (Behavioral)
结局指标
主要结局
Feasibility: Enrollment Rate
时间窗: Up to 6 months
Proportion of eligible patients approached that enroll in the study.
Feasibility: Program Session Completion Rate
时间窗: Up to 6 months
Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Feasibility: Data Collection Completion Rate
时间窗: Up to 6 months
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.
次要结局
- Acceptability: Disenrollment Rate(Up to 6 months)
- Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change(Up to 6 months)
- Acceptability: Satisfaction Rate(Up to 6 months)
- Preliminary efficacy: Quality of Life Change(Up to 6 months)
- Preliminary efficacy: Depression Change(Up to 6 months)
- Preliminary efficacy: Anxiety Change(Up to 6 months)
- Preliminary efficacy: Psychological inflexibility Change(Up to 6 months)
研究者
Oreofe Odejide, MD
Principal Investigator
Dana-Farber Cancer Institute