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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054569
• Other study ID #: NU 20CC18
• Secondary ID: IRG-18-163-24STU
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

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 will 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	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the adapted intervention	Participants will report their satisfaction with individual sessions through brief weekly surveys.	Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
Primary	Acceptability of the adapted intervention	The number of sessions attended, out of a maximum of 10, will be tracked.	Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
Primary	Acceptability of the adapted intervention	Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.	Immediately after the intervention
Secondary	Change in health-related quality of life (HRQOL) 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 symptom burden from baseline to 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.	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 skills self-efficacy 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