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

NCT05584449 — Not applicable, Recruiting, 60 participants, Mayo Clinic

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

RegistryNCT05584449
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment60 (Estimated)
SponsorMayo Clinic (Other)
ConditionsHematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
InterventionsCounseling, Discussion, Informational Intervention, Medical Chart Review, Quality-of-Life Assessment, Questionnaire Administration (Other, procedure)
Datesstart 2023-01-16, primary completion 2027-10-18 (estimated), completion 2027-10-18 (estimated), first posted 2022-10-18, last updated 2026-01-30
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hematopoietic and Lymphoid System Neoplasm All trials for Malignant Solid Neoplasm All trials of Counseling All trials of Discussion

-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Supportive Care (group curriculum)ExperimentalOther: Counseling; Procedure: Discussion; Other: Informational Intervention; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire AdministrationParticipants 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.
  • Counseling (Other), also known as Counseling Intervention: Attend online group facilitated by two oncology social workers
  • Discussion (Procedure), also known as Discuss: Discuss survivorship issues/concerns
  • Informational Intervention (Other): Receive young adult cancer survivorship information
  • Medical Chart Review (Other), also known as Chart Review: Ancillary studies
  • Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
  • Questionnaire Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Sex: All, ages: 18 Years to 39 Years

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

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic in ArizonaScottsdale, ArizonaUnited StatesRecruiting

+Investigators