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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952492
• Other study ID #: STUDY00003230
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: University of Arizona
• Contact: Rachel Jarrett
• Phone: 520-626-0375
• Email: UACC-IIT[@]uacc.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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