Digital Connections: An eHealth Group Intervention for Young Adult Cancer Survivors

Study 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 mental health and stress biomarkers 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.

Official Title
-----------------
Improving Young Adult Cancer Survivors' Mental Health With an eHealth Group Intervention

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Cognitive-Behavioral Stress Management and Health Education


Participation Criteria
=================
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-485) 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: 1) Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Stress Management and Health Education<br>Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content. | Behavioral: Cognitive-Behavioral Stress Management and Health Education<br>* Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nationwide recruitment of young adult cancer survivors | Nationwide recruitment will be considered feasible if ≥40% of eligible survivors enroll in the study. | At the end of the one-year study period | 
| Change in depression symptoms from baseline to immediately after the intervention | Participants will complete the Patient Health Questionnaire-9. Given the sample size, we will focus on effect sizes rather than statistical significance. | Baseline and immediately after the intervention. | 
| Change in anxiety symptoms from baseline to immediately after the intervention | Participants will complete the Generalized Anxiety Disorder-7. Given the sample size, we will focus on effect sizes rather than statistical significance. | Baseline and immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention. | Participants will wear a wearable sensor (e.g., Oura ring) for at least 1 week. | Baseline and the final week of the intervention | 
| Change in health-related quality of life from baseline to immediately after the intervention | Participants will complete the 27-item Functional Assessment of Cancer Therapy - General. Scores range from 0 to 108, with higher scores reflecting better quality of life. | Baseline and immediately after the intervention | 
| Change in cancer-related distress from baseline to immediately after the intervention | Participants will complete the 22-item Impact of Event Scale-Revised. Scores range from 0 to 88, with higher scores indicating greater cancer-related distress. | Baseline and immediately after the intervention | 
| Change in stress management self-efficacy skills from baseline to immediately after the intervention | Participants will complete subscales from the Measure of Current Status. Subscale scores range from 0 to 8, 0 to 12, or 0 to 20 depending on the subscale. Higher scores indicate more of the construct being assessed. | Baseline and immediately after the intervention | 
| Change in coping from baseline to immediately after the intervention | Participants will complete the Brief Coping Orientation to Problems Experienced scale, which yields 14 two-item subscales. Subscale scores range from 2 to 8, with higher scores indicating greater usage of the coping strategy being assessed. | Baseline and immediately after the intervention |