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Completed

NCT Number: NCT05952492

Digital Connections: an EHealth Group Intervention for Young Adult Cancer Survivors

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stress Management Skills Training

Behavioral

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 stress management skills training and health education content.

Primary outcomes

  1. 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

  1. Change in health-related quality of life from baseline to immediately after the intervention

    Time frame: Baseline and 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.

  2. Change in stress management self-efficacy skills from baseline to immediately after the intervention

    Time frame: Baseline and 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.

  3. Change in cancer-related distress from baseline to immediately after the intervention

    Time frame: Baseline and 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.

  4. Change in coping from baseline to immediately after the intervention

    Time frame: Baseline and 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.

  5. Change in anxiety symptoms from baseline to immediately after the intervention

    Time frame: Baseline and immediately after the intervention.

    Participants will complete the Generalized Anxiety Disorder-7. Given the sample size, the investigators will focus on effect sizes rather than statistical significance.

    The Unabbreviated scale title is the Generalized Anxiety Disorder-6. Minimum value=0. Maximum value=21. Higher scores=worse.

  6. Change in depression symptoms from baseline to immediately after the intervention

    Time frame: Baseline and immediately after the intervention.

    Participants will complete the Patient Health Questionnaire-9. Given the sample size, the investigators will focus on effect sizes rather than statistical significance.

    The Unabbreviated scale title is the Patient Health Questionnaire-9. Minimum value=0. Maximum value=27. Higher scores=worse.

  7. Change in trend and relative values of time and frequency domain heart rate variability metrics from pre- to post-intervention.

    Time frame: Baseline and the final week of the intervention

    Participants will wear a wearable sensor for at least 1 week.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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