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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Stress Management and Health Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Jarrett; Phone Number: 520-626-0375; Email: UACC-IIT@uacc.arizona.edu
• Study Contact Backup: Name: Marjorie Barrera; Phone Number: 520-626-6154; Email: marjoriebarrera1@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona Cancer Center
      • Contact: Marjorie Barrera; Phone Number: 520-626-6154; Email: marjoriebarrera1@arizona.edu
      • Contact: Rina S Fox, PhD, MPH; Phone Number: 520-626-3071; Email: rsfox@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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-485)
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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Stress Management and Health Education; 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; 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.

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 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
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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Rina Fox, PhD, MPH, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No