跳至主要内容
临床试验/NCT04636905
NCT04636905已完成不适用

Evaluation of the Survivorship Wellness Group Program: An Interdisciplinary Goal-Setting Clinical Group Program for Survivors of Cancer at UCSF

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年5月26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
53
试验地点
1
主要终点
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time

研究概览

简要总结

Interdisciplinary psychological interventions targeting survivorship are not only understudied but face several implementation challenges. For this project, the study team is proposing to analyze these data to report on preliminary pilot outcomes, as well as acceptability and feasibility of the implementation of the Survivorship Wellness Group Program, an interdisciplinary wellness and health-behavior change program for survivors of cancer, who have completed treatment at University of California, San Francisco and are currently without evidence of active disease.

详细描述

STUDY OBJECTIVES:

  1. To examine the feasibility and acceptability of implementing an interdisciplinary goal-setting clinical group program focused on domains of physical, psychological, and spiritual wellness for survivors of cancer at University of California, San Francisco.

  2. To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

  3. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer

  4. Increasing quality of life

  5. Reducing symptoms of depression and anxiety

  6. Increasing physical activity

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, though finished with active treatments (defined as chemotherapy, radiation, or surgery) at time of enrollment, and without evidence of current active cancer
  • Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

排除标准

  • Non-English speaking
  • Primary cancer treatment outside of UCSF
  • Currently receiving non-maintenance therapies (chemotherapy or radiation) for active cancer
  • Psychiatric illness that would affect the ability to participate in a group activity

结局指标

主要结局

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

时间窗: Up to 16 weeks

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.

Changes in the frequency of participant responses cancer survivorship wellness survey- Knowledge

时间窗: Up to 16 weeks

The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing knowledge is rated by the participant in terms of how knowledgeable the participants are regarding topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all knowledgeable", "Somewhat knowledgeable", "Moderately knowledgeable", "Very knowledgeable", and "Extremely knowledgeable".

Frequency of participant responses to Program Satisfaction survey item

时间窗: Week 16

Program satisfaction is measured by the participant's response to the following item: "How satisfied were you, overall, with this program?". Responses ranged from Not at all satisfied, Somewhat satisfied, Mostly satisfied, and Extremely satisfied. Responses will be counted and reported by category.

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

时间窗: Up to 16 weeks

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 the frequency of participant responses cancer survivorship wellness survey: Importance

时间窗: Up to 16 weeks

The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing importance is rated by the participant in terms of how important it is to learn about topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all important", "Somewhat important", "Moderately important", "Very important", and "Extremely important".

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

时间窗: Up to 16 weeks

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.

Changes in the frequency of participant responses to exercise frequency survey item

时间窗: Up to 16 weeks

The frequency of current exercise for participants was measured by a single item "How frequently do you exercise currently"? Responses are comprised of 5 categories: "Every day", "Several times per week", "Once per week", "Less than once per week", "Several times per month", "Once per month", and "Less than once per month"

Changes in the frequency of participant responses to exercise intensity survey item

时间窗: Up to 16 weeks

The intensity of current exercise for participants was measured by a single item "How would you rate the intensity of your current exercise regimen?". Responses are comprised of 5 categories: "Very low intensity", "Light intensity", "Moderate intensity", and "High intensity".

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)

Loading locations...

相似试验