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NCT Number: NCT05584449

Group Curriculum for Improving Survivorship Outcomes in Adolescent and Young Adult Cancer Survivors

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.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Counseling

Other

Attend online group facilitated by two oncology social workers

Other names: Counseling Intervention

Discussion

Procedure

Discuss survivorship issues/concerns

Other names: Discuss

Informational intervention

Other

Receive young adult cancer survivorship information

medical chart review

Other

Ancillary studies

Other names: Chart Review

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in quality of life

    Time frame: 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.

Secondary outcomes

  1. Change in well-being

    Time frame: Baseline and 6 weeks

    Will be measured using the Warwick-Edinburgh Mental Wellbeing scale (WEMWBS). 14 responses may be aggregated to provide a single score. The WEMWBS scale is a validated measurement of group mental well-being, which examines participants' hedonic and eudaemonic perspectives. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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