CompletedNot Applicable

Expressive Storytelling to Share Adolescents/Young Adults Cancer Stories

United States15 participantsStarted 2021-11-10

Plain-language summary

The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of an online expressive storytelling intervention for adolescents and young adults (AYA) with cancer. * Specific Aim 1. To evaluate the feasibility and acceptability of a 5-week online expressive storytelling intervention. We will (a) conduct a 1-group pre- and post-test study with 20 AYA with cancer and (b) examine feasibility and acceptability through study enrollment rates, retention rates, usability score, adherence and data collection rates, satisfaction score, perceived benefits score, and intervention fidelity. \*Hypothesis 1: We will reach following feasibility and acceptability benchmarks: (a) \>70% enrollment of eligible participants, (b) \>70% retention, (c) \>75% adherence and data collection, (d) \>70 out of 100 usability score, (e) \>5 out of 7 satisfaction score, (f) \>average 5 on the perceived benefits score, and (g) \>3 out of 4 fidelity score. * Specific Aim 2. To assess preliminary efficacy of a 5-week online expressive storytelling intervention. * Hypothesis 2: AYA participants will report lower psychosocial distress, higher health-related quality of life, and higher well-being scores postintervention.

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.2 Patients must have any type of histologically or cytologically confirmed malignancy during adolescence or young adulthood.
.3 Patients may be at any stage of the cancer trajectory. Participants can be enrolled beginning one month after an initial cancer diagnosis.
.4 Patients must be cognitively intact.
.5 Patients must have access to the internet using their own electronic devices (e.g., laptop, desktop, tablet PC, smartphone).
.6 Ability to speak, write, read, understand English.

Exclusion criteria

.2 Patients who show their unwillingness to participate in the program by their actions (e.g., providing false information, just giggling rather than answering questions, increases in aggression or anxiety) can be discussed to make a decision about honoring their desire to withdraw from participation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Secure Flourish Measure (Adolescent Version)

Timeframe: Day 0, Day 35

Change in Secure Flourish Measure (Adult Version)

Timeframe: Day 0, Day 35

Change in Herth Hope Index Scale

Timeframe: Day 0, Day 35

Change in Perceived Social Support from Health Care Professionals

Timeframe: Day 0, Day 35

Change in Self-transcendence Scale

Timeframe: Day 0, Day 35

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v. 2.1 (Adult Version)

Timeframe: Day 0, Day 35

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 25 v. 2.0 (Adolescent Version)

Timeframe: Day 0, Day 35

Trial details

NCT IDNCT04855487

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Pediatric Cancer trials

Plain-language summary

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.2 Patients must have any type of histologically or cytologically confirmed malignancy during adolescence or young adulthood.
.3 Patients may be at any stage of the cancer trajectory. Participants can be enrolled beginning one month after an initial cancer diagnosis.
.4 Patients must be cognitively intact.
.5 Patients must have access to the internet using their own electronic devices (e.g., laptop, desktop, tablet PC, smartphone).
.6 Ability to speak, write, read, understand English.

Exclusion criteria

.2 Patients who show their unwillingness to participate in the program by their actions (e.g., providing false information, just giggling rather than answering questions, increases in aggression or anxiety) can be discussed to make a decision about honoring their desire to withdraw from participation.

What they're measuring

Change in Secure Flourish Measure (Adolescent Version)

Timeframe: Day 0, Day 35

Change in Secure Flourish Measure (Adult Version)

Timeframe: Day 0, Day 35

Change in Herth Hope Index Scale

Timeframe: Day 0, Day 35

Change in Perceived Social Support from Health Care Professionals

Timeframe: Day 0, Day 35

Change in Self-transcendence Scale

Timeframe: Day 0, Day 35

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v. 2.1 (Adult Version)

Timeframe: Day 0, Day 35

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 25 v. 2.0 (Adolescent Version)

Timeframe: Day 0, Day 35