Tech-TYA: eHealth Platform to Deliver Group Intervention for YA Cancer Survivors

Adapting and Testing an eHealth Platform to Deliver a Group Intervention for Young Adult Cancer Survivors

The purpose of this study is to adapt a web-based platform to deliver a 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 a website to deliver an evidence-based intervention for improving HRQOL for young adult cancer survivors, and then conducted usability testing sessions with young adult cancer survivors to get feedback on the website. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the website will be used to deliver the intervention via weekly group meetings with a trained facilitator over the course of 10 weeks.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18-39 years at the time of participation
2. Diagnosed with a primary cancer between 18-39 years old
3. Finished cancer treatment with curative intent 1 month to 5 years prior to enrollment (except hormone therapy)
4. NED and no anticipated/scheduled anti-cancer treatments at the time of enrollment (except hormone therapy)
5. Able to speak and read English
6. Able and willing to give informed consent
7. Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences (Part 2 only)

Exclusion Criteria:

1. Ongoing or future anti-cancer treatments (beyond hormone therapy) are scheduled or anticipated
2. Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)

Vulnerable populations will not be included in this study.

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: Behavioral: Cognitive-Behavioral Stress Management and Health Education; 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 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
Change in satisfaction of the eHealth intervention delivery	Immediately after the intervention, each week participants will report their satisfaction with the full program through a brief survey.	Change in satisfaction from week 1 to week 10
Acceptability of the eHealth intervention delivery	Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.	At the end of the 10-week intervention
Acceptability of the eHealth intervention delivery	The number of sessions attended, out of a maximum of 10, will be recorded	At the end of the 10-week intervention, the number of sessions attended will be recorded

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 anxiety symptoms from baseline to immediately after the intervention	Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotion Distress-Anxiety Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more symptoms of anxiety.	Baseline and immediately after the intervention
Change in perceived cognitive function from baseline to immediately after the intervention	Participants will complete the PROMIS Cognitive Function Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better perceived cognitive function.	Baseline and immediately after the intervention
Change in depression symptoms from baseline to immediately after the intervention	Participants will complete the PROMIS Cognitive Function Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better perceived cognitive function.	Baseline and immediately after the intervention
Change in perceived emotional support from baseline to immediately after the intervention	Participants will complete the PROMIS Emotional Support Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate greater perceived emotional support.	Baseline and immediately after the intervention
Change in fatigue from baseline to immediately after the intervention	Participants will complete the PROMIS Fatigue Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more fatigue.	Baseline and immediately after the intervention
Change in pain interference from baseline to immediately after the intervention	Participants will complete the PROMIS Pain Interference Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more pain interference.	Baseline and immediately after the intervention
Change in patient-reported physical function from baseline to immediately after the intervention	Participants will complete the PROMIS Physical Function Short Form 4a. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better patient-reported physical function.	Baseline and immediately after the intervention
Change in pain intensity from baseline to immediately after the intervention	Participants will complete the PROMIS Pain Intensity 1a. Scores range from 0 to 10, with higher scores indicating greater pain intensity.	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 stress management self-efficacy skills 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
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

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Neoplasms; Quality of life; Young adults
• Other Study ID Numbers: STUDY00000717

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