NCT05584449

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2023Oct 2027

First Submitted

Initial submission to the registry

October 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

October 11, 2022

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life

    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.

    Baseline and 6 weeks

Secondary Outcomes (1)

  • Change in well-being

    Baseline and 6 weeks

Study Arms (1)

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.

Other: CounselingProcedure: DiscussionOther: Informational InterventionOther: Medical Chart ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Attend online group facilitated by two oncology social workers

Also known as: Counseling Intervention
Supportive Care (group curriculum)
DiscussionPROCEDURE

Discuss survivorship issues/concerns

Also known as: Discuss
Supportive Care (group curriculum)

Receive young adult cancer survivorship information

Supportive Care (group curriculum)

Ancillary studies

Also known as: Chart Review
Supportive Care (group curriculum)

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (group curriculum)

Ancillary studies

Supportive Care (group curriculum)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Melody A Griffith, MSW, LISW

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 18, 2022

Study Start

January 16, 2023

Primary Completion (Estimated)

October 18, 2027

Study Completion (Estimated)

October 18, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations