跳至主要内容
临床试验/NCT04659993
NCT04659993终止不适用

Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Change in Self-Efficacy in Pandemic Conditions

研究概览

简要总结

The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.

详细描述

Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.

Secondary Objective: To reduce depression and anxiety levels through meaning-making.

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 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
  • Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
  • Aged 18-39
  • Must speak English
  • Must have computer with audio and visual capabilities.
  • Must live within North Carolina
  • Must have experienced health-related anxiety and/or distress in last 3 months.

排除标准

  • Exclusion criteria will be determined by pre-screening data and medical chart reviews
  • Active inpatient hospitalization
  • Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
  • Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
  • Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
  • Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
  • Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
  • Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.

结局指标

主要结局

Change in Self-Efficacy in Pandemic Conditions

时间窗: At baseline up to 8 weeks

The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.

次要结局

  • Changes in Depression and Anxiety Levels (CAS)(At baseline up to 8 weeks)
  • Changes in Depression and Anxiety Levels (PIL)(At baseline up to 8 weeks)
  • Changes in Depression and Anxiety Levels (MAC)(At baseline up to 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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