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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597228
• Other study ID #: STUDY00000717
• Status: Completed
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

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 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	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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 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
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