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Clinical Trials/NCT05597228
NCT05597228
Completed
Not Applicable

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

University of Arizona1 site in 1 country7 target enrollmentJune 9, 2022
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Arizona
Enrollment
7
Locations
1
Primary Endpoint
Satisfaction with the eHealth intervention delivery
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2022
End Date
April 25, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Satisfaction with the eHealth intervention delivery

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

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

Acceptability of the eHealth intervention delivery

Time Frame: 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 Outcomes

  • Change in anxiety symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in depression symptoms from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in coping from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in stress management self-efficacy skills from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in perceived emotional support from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in fatigue from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in perceived cognitive function from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in pain interference from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in patient-reported physical function from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in pain intensity from baseline to immediately after the intervention(Baseline and immediately after the intervention)
  • Change in cancer-related distress from baseline to immediately after the intervention(Baseline and immediately after the intervention)

Study Sites (1)

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