跳至主要内容
临床试验/NCT05584449
NCT05584449招募中不适用

Determining the Impact of a Curriculum for a Cancer Survivorship Group for Adolescents and Young Adults (AYA)

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
60
试验地点
2
主要终点
Change in quality of life

研究概览

简要总结

This clinical trial studies the effectiveness of a group curriculum in improving survivorship outcomes in adolescent and young adult (AYA) cancer survivors. Many AYA survivors typically do not feel prepared to re-enter "daily life" and would likely benefit from structured interventions to offer education and support in a timely manner as to prepare them for the challenges of life in survivorship. A 6-week group curriculum, designed to specifically meet the needs of AYA cancer survivors and facilitated by licensed social workers, may meet the unique needs of young adults who have survived a cancer diagnosis, and if so, the curriculum could be licensed and used across Mayo Clinic sites and potentially at other cancer centers nationwide.

详细描述

PRIMARY OBJECTIVES:

I. Social workers will develop a curriculum to facilitate psychoeducational, skill-based, and process-oriented group for patients who have entered survivorship.

II. To determine if a specific 6 weeklong psychoeducational, skill-based, and process-oriented peer group curriculum results in improved quality of life for adolescents and young adult cancer survivors.

III. To demonstrate the feasibility of this curriculum to address the needs of this population.

OUTLINE:

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

  • Age 18-39
  • Is a patient of Mayo Clinic Arizona for oncologic care and/or follow-up
  • History of cancer diagnosis
  • Treated with curative intent
  • Completed cancer treatment within 6 months to 2 years prior to group attendance
  • Ability to read/write/speak English
  • Ability to participate in a group setting
  • Ability to commit to attending all six group meetings

排除标准

  • Inability to read/write/speak English
  • No internet or computer access
  • Not receiving care at Mayo Clinic Arizona
  • Currently receiving treatment for cancer
  • Is unable to sit comfortably for 90 minutes
  • Was not treated with curative intent
  • Is on hospice care
  • Co-morbid systemic illness or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessments

研究组 & 干预措施

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Counseling (Other)

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Discussion (Procedure)

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Informational Intervention (Other)

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Medical Chart Review (Other)

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Quality-of-Life Assessment (Other)

Supportive Care (group curriculum)

Experimental

Participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Change in quality of life

时间窗: Baseline and 6 weeks

Will be measured using the Quality of Life Patient/Cancer Survivor Version (QOL-CSV). The QOL-CSV is based on pre-existing versions of the City of Hope's QOL instrument. A pilot study conducted by Hassey-Dow and Farrell provided data which resulted in the revision of the QOL into 41 items that represent four domains of quality of life as pertaining to cancer survivorship: physical, psychological, social, and spiritual well-being. Only the psychological well-being, social concerns, and spiritual well-being components will be used. A two-sided paired t-test for the difference in the mean response will be conducted. A significance level of 0.05 will be used. If the data violate normality assumptions, a non-parametric alternative will be used. Additional summary statistics such as the proportion of participants who reported an improvement in QOL-CSV score may be used as appropriate.

次要结局

  • Change in well-being(Baseline and 6 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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