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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05584449
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
23
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Counseling
  • Procedure: Discussion
  • Other: Informational Intervention
  • Other: Medical Chart Review
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

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

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Determining the Impact of a Curriculum for a Cancer Survivorship Group for Adolescents and Young Adults (AYA)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (group curriculum)

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.

Other: Counseling
Attend online group facilitated by two oncology social workers
Other Names:
  • Counseling Intervention

    • Procedure: Discussion
    Discuss survivorship issues/concerns
    Other Names:
  • Discuss

    • Other: Informational Intervention
    Receive young adult cancer survivorship information

    Other: Medical Chart Review
    Ancillary studies
    Other Names:
  • Chart Review

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in quality of life [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 Outcome Measures

    1. Change in well-being [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Melody A Griffith, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05584449
    Other Study ID Numbers:
    • 21-007844
    • NCI-2022-07825
    First Posted:
    Oct 18, 2022
    Last Update Posted:
    Jan 6, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2023