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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Stress Management and Health Education

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-week eHealth intervention; Weekly video conference groups led by a trained facilitator	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: American Cancer Society, Inc.

Publications and helpful links

General Publications

• Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NU 20CC18; IRG-18-163-24 (Other Grant/Funding Number: American Cancer Society); STU00214055 (Other Identifier: Northwestern University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No