Clinical trial NCT05952492: Digital Connections: an EHealth Group Intervention for Young Adult Cancer Survivors
Official title: Improving Young Adult Cancer Survivors' Mental Health with an EHealth Group Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility of recruitment of young adult cancer survivors
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in health-related quality of life from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in stress management self-efficacy skills from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in cancer-related distress from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in coping from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in anxiety symptoms from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention.
measure: Change in depression symptoms from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention.
measure: Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.
timeFrame: Baseline and the final week of the intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Rina Fox, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: