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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584449
• Other study ID #: 21-007844
• Secondary ID: NCI-2022-07825
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: October 18, 2024

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 18, 2024
• Est. primary completion date: October 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

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

Procedure:
• Discussion
Discuss survivorship issues/concerns

Other:
• Informational Intervention
Receive young adult cancer survivorship information
• Medical Chart Review
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in well-being	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.	Baseline and 6 weeks