Group Curriculum for Improving Survivorship Outcomes in Adolescent and Young Adult Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to read/write/speak English
No internet or computer access
Not receiving care at Mayo Clinic Arizona
Currently receiving treatment for cancer
Trial design
Design model
Single group
Treatments tested in this trial
Counseling
Other interventionAttend online group facilitated by two oncology social workers
Discussion
Procedure/SurgeryDiscuss survivorship issues/concerns
Informational Intervention
Other interventionReceive young adult cancer survivorship information
Medical Chart Review
Other interventionAncillary studies
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Supportive Care (group curriculum)Experimental treatment 6 interventions
Trial outcomes
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.
Time frame
Baseline and 6 weeksSecondary outcomes
1
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.
Time frame
Baseline and 6 weeksSponsors and contacts
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Source ClinicalTrials.gov