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CancerNCT05597228

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

A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer
What is being tested?
Cognitive-Behavioral Stress Management and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
9 Jun 2022to 25 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Cancer
Being tested
Cognitive-Behavioral Stress Management and Health Education
Keywords
Neoplasms, Quality of life, Young adults
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioral Stress Management and Health EducationBehavioural

    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.

Study groups in NCT05597228
Study groupRoleWhat they receive
Behavioral: Cognitive-Behavioral Stress Management and Health EducationExperimentalWeekly video conference groups led by a trained facilitator
Receives: Behavioral: Cognitive-Behavioral Stress Management and Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with the eHealth intervention delivery

    Immediately after the intervention and each week participants will report their satisfaction with the full program through a brief survey.

    Measured: At the end of the 10-week intervention, overall and weekly satisfaction scores will be compiled

  2. Acceptability of the eHealth intervention delivery

    Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.

    Measured: At the end of the 10-week intervention

  3. Acceptability of the eHealth intervention delivery

    The number of sessions attended, out of a maximum of 10, will be recorded

    Measured: At the end of the 10-week intervention, the number of sessions attended will be recorded

Secondary outcomes (12)

  1. 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.

    Measured: Baseline and immediately after the intervention

  2. 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.

    Measured: Baseline and immediately after the intervention

  3. 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.

    Measured: Baseline and immediately after the intervention

  4. 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.

    Measured: Baseline and immediately after the intervention

  5. 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.

    Measured: Baseline and immediately after the intervention

  6. 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.

    Measured: Baseline and immediately after the intervention

  7. 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.

    Measured: Baseline and immediately after the intervention

  8. 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.

    Measured: Baseline and immediately after the intervention

  9. 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.

    Measured: Baseline and immediately after the intervention

  10. 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.

    Measured: Baseline and immediately after the intervention

  11. 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.

    Measured: Baseline and immediately after the intervention

  12. 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.

    Measured: Baseline and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start9 Jun 2022
  3. Primary completion25 Apr 2023
  4. Study completion25 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05597228
Sponsor's protocol ID
STUDY00000717
Status last verified
Aug 2024
First submitted
21 Sep 2022
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fox RS, Badger TA, Moya S, Gudenkauf LM, Nelson MA, O'Neill RM, Leete JJ, Friedman SE, Katsanis E, Victorson DE, Sanford SD, Penedo FJ, Antoni MH, Oswald LB. An HRQOL Proof-Of-Concept Analysis of the eHealth TOGETHER Intervention for Adolescent and Young Adult Cancer Survivors: A Brief Report. Psychooncology. 2025 Jul;34(7):e70234. doi: 10.1002/pon.70234.

    PubMed 40879639

  • Fox RS, Torres TK, Badger TA, Katsanis E, Yang D, Sanford SD, Victorson DE, Yanez B, Penedo FJ, Antoni MH, Oswald LB. Delivering a Group-Based Quality of Life Intervention to Young Adult Cancer Survivors via a Web Platform: Feasibility Trial. JMIR Cancer. 2024 Dec 4;10:e58014. doi: 10.2196/58014.

    PubMed 39631050

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Stress Management and Health Education in people with Cancer, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with the eHealth intervention delivery (time frame: At the end of the 10-week intervention, overall and weekly satisfaction scores will be compiled). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05597228, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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