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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05054569
Enrollment
6
Registered
2021-09-23
Start date
2021-09-01
Completion date
2021-12-15
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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

Detailed description

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.

Interventions

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.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the adapted interventionOver the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly sessionParticipants will report their satisfaction with individual sessions through brief weekly surveys.

Secondary

MeasureTime frameDescription
Change in health-related quality of life (HRQOL) from baseline to immediately after the interventionBaseline and immediately after the interventionParticipants 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.
Change in symptom burden from baseline to immediately after the interventionBaseline and immediately after the interventionParticipants 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.
Change in cancer-related distress from baseline to immediately after the interventionBaseline and immediately after the interventionParticipants will complete the 22-item Impact of Event Scale-Revised. Scores range from 0 to 88, with higher scores indicating greater cancer-related distress.
Change in stress management skills self-efficacy from baseline to immediately after the interventionBaseline and immediately after the interventionParticipants 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.
Change in coping from baseline to immediately after the interventionBaseline and immediately after the interventionParticipants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026