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

Sponsor
University of Arizona (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597228
Collaborator
(none)
10
1
1
3.8
2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive-Behavioral Stress Management and Health Education
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Adapting and Testing an eHealth Platform to Deliver a Group Intervention for Young Adult Cancer Survivors
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in satisfaction of the eHealth intervention delivery [Change in satisfaction from week 1 to week 10]

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

  2. Acceptability of the eHealth intervention delivery [At the end of the 10-week intervention]

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

  3. Acceptability of the eHealth intervention delivery [At the end of the 10-week intervention, the number of sessions attended will be recorded]

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

Secondary Outcome Measures

  1. Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention [Baseline and 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.

  2. Change in anxiety symptoms from baseline to immediately after the intervention [Baseline and 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.

  3. Change in perceived cognitive function from baseline to immediately after the intervention [Baseline and 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.

  4. Change in depression symptoms from baseline to immediately after the intervention [Baseline and 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.

  5. Change in perceived emotional support from baseline to immediately after the intervention [Baseline and 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.

  6. Change in fatigue from baseline to immediately after the intervention [Baseline and 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.

  7. Change in pain interference from baseline to immediately after the intervention [Baseline and 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.

  8. Change in patient-reported physical function from baseline to immediately after the intervention [Baseline and 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.

  9. Change in pain intensity from baseline to immediately after the intervention [Baseline and 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.

  10. Change in cancer-related distress from baseline to immediately after the intervention [Baseline and 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.

  11. Change in stress management self-efficacy skills from baseline to immediately after the intervention [Baseline and 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.

  12. Change in coping from baseline to immediately after the intervention [Baseline and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arizona Cancer Center Tucson Arizona United States 85724

Sponsors and Collaborators

  • University of Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arizona
ClinicalTrials.gov Identifier:
NCT05597228
Other Study ID Numbers:
  • STUDY00000717
First Posted:
Oct 28, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arizona

Study Results

No Results Posted as of Dec 1, 2022