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

Study Overview
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Brief Summary
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The purpose of this study is to adapt a web-based platform to deliver a group intervention for young adult cancer survivors.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Stress Management and Health Education


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral: Cognitive-Behavioral Stress Management and Health Education<br>Weekly video conference groups led by a trained facilitator | Behavioral: Cognitive-Behavioral Stress Management and Health Education<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Quality of life, Young adults