Clinical trial NCT05597228: Tech-TYA: eHealth Platform to Deliver Group Intervention for YA Cancer Survivors
Official title: Adapting and Testing an eHealth Platform to Deliver a Group Intervention for Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Neoplasms
Quality of life
Young adults
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction with the eHealth intervention delivery
timeFrame: At the end of the 10-week intervention, overall and weekly satisfaction scores will be compiled
measure: Acceptability of the eHealth intervention delivery
timeFrame: At the end of the 10-week intervention
measure: Acceptability of the eHealth intervention delivery
timeFrame: At the end of the 10-week intervention, the number of sessions attended will be recorded
Secondary outcomes:
measure: Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in anxiety symptoms from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in perceived cognitive function from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in depression symptoms from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in perceived emotional support from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in fatigue from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in pain interference from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in patient-reported physical function from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in pain intensity from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in cancer-related distress from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in stress management self-efficacy skills from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in coping from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
References: