跳至主要内容
临床试验/NCT04636346
NCT04636346已完成不适用

Evaluation of Compass: A Group Clinical Program in Psycho-Oncology Using Acceptance and Commitment Therapy to Address Fear of Recurrence/Progression in Cancer Survivors

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2020年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Changes in Acceptance and Action Questionnaire II (AAQ-II) scores over time

研究概览

简要总结

Cancer Center Psychosocial services (Psycho-Oncology) offers group psychoeducational and behavioral programs as part of its clinical service for cancer patients and services at the Helen Diller Family Comprehensive Cancer Center. Clinical outcomes and acceptability/feasibility and implementation process data from these programs are routinely gathered in an effort to engage in continuous quality improvement for the department.

详细描述

For this project, the study team is proposing to retrospectively analyze a de-identified data set of these data to report on pilot data on preliminary outcomes, acceptability and feasibility of the implementation of the COMPASS: Acting Mindfully for a Valued Life, based upon Acceptance and Commitment Therapy, an evidence-based behavioral intervention and facilitated by a licensed clinical psychologist in our department. This intervention was implemented as a series of clinical offerings for seven 7-session groups between September 2015 and October 2018 for 113 individual cancer patients and survivors. Outcomes measured include anxiety, depression, fear of recurrence, psychological flexibility, mindfulness; values based living, and quality of life. Participants completed surveys at 4 time points, pre and post, and two followup time points. Measures of demographics, satisfaction and feasibility/acceptability were also collected. Insights gathered from this study will be used to inform articles, grant applications and conference presentations on the implementation of behavioral interventions for cancer patients and survivors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking
  • Treated for any kind of cancer at University of California, San Francisco
  • Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

排除标准

  • Non-English speaking
  • Treated elsewhere for cancer
  • Psychiatric illness that would affect the ability to participate in a group activity

结局指标

主要结局

Changes in Acceptance and Action Questionnaire II (AAQ-II) scores over time

时间窗: Up to 1 year

The AAQ-II is a 7 item questionnaire used to track how participants are doing with applying psychological flexibility skills in their daily life. Item scores range from 1 ("never true") to 7 ("always true":), and total scores are computed by adding up responses for each question. Higher total scores mean less flexibility, while lower total scores mean more flexibility.

Changes in Happiness Index Profile (HI/P10) scores over time

时间窗: Up to 1 year

The HI/P10 is a 10-item questionnaire assessing positive affect, intention, and resiliency. Each item is scored from 0 (strongly disagree) to 10 (strongly agree). HI/P10 scores are calculated by adding the scores for each item to generate a total score out of 100.

Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time

时间窗: Up to 1 year

The PROMIS Anxiety Short form consists of 2 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.

Changes in the Valuing Questionnaire (VQ) scores over time

时间窗: Up to 1 year

The VQ is a 10-item scale designed to measure how consistently an individual has been living with their self-determined values and is helpful when administered during a course of Acceptance and Commitment Therapy (ACT). Two subscale scores are measured: Progress and Obstruction. Progress items (Range = 0 to 30) are defined as enactment and perseverance in living consistently with one's values. Higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (Range = 0 to 30) represents the extent to which various disruptions "got in the way" of valued living. Higher scores represent more interference with living consistently with one's values. Total scores are calculated by summing the raw scores and calculating percentile ranks. When used as a monitoring tool during a course of ACT, successful treatment is indicated by increasing Progress Scores and decreasing Obstruction Scores.

Changes in The Fear of Cancer Recurrence Index (FCRI) severity subscale scores over time

时间窗: Up to 1 year

The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"). A higher score indicates higher levels of FCR.

Changes in the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12) scores over time

时间窗: Up to 1 year

The FACIT-SP-12 is a 12 item questionnaire which measures a participants spiritual well-being for the past 7 days. Item responses range from 0 (not at all) to 4 (very much). The sum of the item scores are used to calculate a total FACIT-SP-12 score ranging from 0 to 48. The higher the score, the better the QOL/spiritual well-being.

Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form scores over time

时间窗: Up to 1 year

The PROMIS Depression Short form consists of 4 items addressing patient depression with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of depression. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.

Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time

时间窗: Up to 1 year

The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each tem response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL.

Changes in Five Facet Mindfulness Questionnaire (FFMQ) scores over time

时间窗: Up to 1 year

The FFMQ is a 39-item questionnaire that measures five factors which represent elements of mindfulness. The five facets are Observing, Describing, Acting with awareness, Non-judging of inner experience, and Non-reactivity to inner experience. Item scores range from 1 ("never or very rarely true") to 5 ("very often or always true":), and total scores are computed by adding up responses for the questions that fall into each facet, for a range of 8-40 per facet with the exception of the Non-react scores which range from 7-35. Higher scores on the Observe, React, and Non-react facets indicate higher levels of mindfulness and higher scores on the Act with Awareness and Non-judge items indicate less mindfulness.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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