Improving Young Adult Cancer Survivors' Mental Health with an EHealth Group Intervention

University of Arizona1 site in 1 country32 target enrollmentJanuary 16, 2024

ConditionsCancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cancer
Sponsor: University of Arizona
Enrollment: 32
Locations: 1
Primary Endpoint: Feasibility of recruitment of young adult cancer survivors
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population.

Detailed Description

Study investigators will conduct a single-arm pilot trial in which a 10 week eHealth group intervention will be delivered via a study website. We will use a multi-pronged approach to recruit young adult cancer survivors from across the country. Study participants will attend weekly group meetings with a trained facilitator to receive the manualized intervention over the course of 10 weeks.

Registry

clinicaltrials.gov

Start Date

January 16, 2024

End Date

October 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Arizona

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-39 years at the time of participation
•Diagnosed with any invasive cancer between 15-39 years old
•Finished curative cancer treatment 1 month to 5 years prior to enrollment (except maintenance therapy such as ongoing hormone therapy)
•Currently experiencing at least mild symptoms of depression or anxiety (i.e., score ≥1 on the Patient Health Questionnaire-4)
•Able to speak and read English so all group attendees can communicate in a shared language.
•Able and willing to give informed consent.
•Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion Criteria

•Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

Outcomes

Primary Outcomes

Feasibility of recruitment of young adult cancer survivors

Time Frame: Through study completion, an average of 1 year

Recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study.

Secondary Outcomes

Change in health-related quality of life from baseline to immediately after the intervention(Baseline and immediately after the intervention)
Change in stress management self-efficacy skills from baseline to immediately after the intervention(Baseline and immediately after the intervention)
Change in cancer-related distress from baseline to immediately after the intervention(Baseline and immediately after the intervention)
Change in coping from baseline to immediately after the intervention(Baseline and immediately after the intervention)
Change in anxiety symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention.)
Change in depression symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention.)
Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.(Baseline and the final week of the intervention)