Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04855487 |
Other study ID # |
VR55572 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 10, 2021 |
Est. completion date |
May 1, 2022 |
Study information
Verified date |
June 2022 |
Source |
Vanderbilt University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
- Rationale/Significance of Study: Cancer is one of life's most stressful and serious
illnesses for adolescents and young adults (AYA). In 2021, approximately 15,000 AYA ages
15 to 25 years are expected to be newly diagnosed with cancer in the United States.
Despite high survival rates exceeding 85%, the burden of cancer and its' treatment for
AYA is substantial and prolonged due to their unique developmental characteristics. AYA
with cancer often deal with the difficulties of transition from pre-cancer to treatment
trajectory while also transitioning from adolescence to young adulthood. While they
suffer from physical, emotional, psychosocial, and financial burdens as a result of
cancer, establishing resources for future development and well-being, such as identity
and goal development, education, and social relationships, often becomes secondary
during treatment because of concerns about survival. As a result, AYA with cancer have
less opportunities to be prepared for their lifelong challenges and build abilities to
deal with such complex suffering, which lead to maladjustment, hinder social
reintegration, and limit their ongoing well-being. Thus, there is a critical need to
deliver developmentally appropriate supportive care for AYA with cancer to reduce the
potential risk of negative consequences and improve capacities to thrive throughout
their life trajectories. The proposed study aims to test the feasibility, acceptability,
and preliminary efficacy of an expressive storytelling intervention for AYA with cancer,
helping them create and share their stories.
- Theoretical Framework: The theoretical framework of our study and the intervention
contents are designed following the Story Theory in nursing practice and the
Self-transcendence Theory. Our intervention development process follows the
Obesity-Related Behavioral Intervention Trials (ORBIT) model to develop and evaluate
complex interventions.
- Design and Procedures: A single-group pre- and post-test clinical trial design will be
applied. A total of 20 dyads of AYA with cancer will be recruited. Each AYA will be
asked to think of three to five of their primary nurses as audiences of their stories
created during the 5-week online storytelling intervention. The AYA participant will
create digital stories about themselves following the guiding questions. The dyad will
then participate in weekly online meetings with nursing research staff, during which
they will introduce their stories and discuss their reflections. Participants will
complete pre- (T1) and post-intervention (T2) measures and share their qualitative
feedback.
- Implications for Practice: Results will serve as the foundational knowledge to conduct a
large-scale, randomized clinical trial. Ultimately, this study will promote well-being
and improve palliative and psychosocial nursing care to individuals with serious
illness, including AYA with cancer.