Skip to main content
OpenTrials
Completed

NCT Number: NCT05054569

Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors

The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator 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

  • age 18-39 years at the time of participation
  • diagnosed with a non-metastatic primary cancer between 18-39 years old
  • completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment
  • able to speak and read English
  • access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion criteria

  • metastatic disease
  • psychiatric or neurological disorders that could interfere with study participation
  • considered part of a vulnerable population

Treatment and study plan

Cognitive-Behavioral Stress Management and Health Education

Behavioral

Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.

Primary outcomes

  1. Acceptability of the adapted intervention

    Time frame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session

    Participants will report their satisfaction with individual sessions through brief weekly surveys.

  2. Acceptability of the adapted intervention

    Time frame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session

    The number of sessions attended, out of a maximum of 10, will be tracked.

  3. Acceptability of the adapted intervention

    Time frame: Immediately after the intervention

    Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.

Secondary outcomes

  1. Change in health-related quality of life (HRQOL) 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 symptom burden from baseline to immediately after the intervention

    Time frame: Baseline and immediately after the intervention

    Participants will complete a modified version of the Edmonton Symptom Assessment Scale, which assesses 10 common cancer-related symptoms each on a numerical rating scale ranging from 0 to 10. Higher scores indicate greater symptom burden.

  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 stress management skills self-efficacy 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2021
Registry last updated
Jan 4, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.