Expressive Storytelling to Share Adolescents/Young Adults Cancer Stories

NCT04855487 | Completed

• 1 other identifier: VR55572
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer; Growth, Posttraumatic; Nurse-Patient Relations; Narrative Medicine

Keywords

Storytelling; Adolescents and young adults with cancer; Nursing intervention; Human flourishing; Resilience

Outcome Measures

Primary Outcomes (9)

• Change in Secure Flourish Measure (Adolescent Version)

  A 12-item 10-point Likert scale measure ranging from 0 (Not Satisfied at Aall) to 10 (Completely Satisfied) to assess adolescents' level of human flourishing. This measure is tailored to adolescents (12-18 years old).

  Day 0, Day 35

• Change in Secure Flourish Measure (Adult Version)

  A 12-item 10-point Likert scale measure ranging from 0 (Not Satisfied at All) to 10 (Completely Satisfied) to assess young adults' level of human flourishing. This measure is tailored to individuals over 18 years old.

  Day 0, Day 35

• Change in Herth Hope Index Scale

  A 12-item 4-point Likert scale measure ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) to assess hope in adolesents and young adults with cancer.

  Day 0, Day 35

• Change in Perceived Social Support from Health Care Professionals

  A 20-item 5-point Likert scale measure ranging from 1 (Totally Disagree) to 5 (Totally Agree) to asess adolescent/young adults' perceived social support from health care providers

  Day 0, Day 35

• Change in Self-transcendence Scale

  A 15-item 4-point Likert scale measure ranging from 1 (Not at All) to 4 (Very Much) to assess the level of self-transcendence in adolescents/young adults with cancer

  Day 0, Day 35

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

  A measure consists of 28 5-point Likert scale items and one 11-point Likert scale item (asking about general pain) to assess the self-perceived health related quality of life in young adults with cancer

  Day 0, Day 35

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

  A measure consists of 24 5-point Likert scale items and one 11-point Likert scale item (asking about general pain) to assess the self-perceived health related quality of life in adolescents with cancer

  Day 0, Day 35

• Satisfaction Survey

  A 16-item survey to assess participants' satisfaction of the intervention program. Ten 7-point Likert scale items assess satisfaction, and 6 items assess perceived benefits of the intervention.

  Day 35

• System Usability Survey

  A 10-item survey to assess participants' perceived usability of the intervention program. This scale uses 5-point Likert scale (range from Strongly Agree to Strongly Disagree).

  Day 35

Study Arms (1)

Intervention group

EXPERIMENTAL

Adolescents/young adults with cancer will participate in a 5-week online expressive storytelling intervention. They will independently create digital stories about themselves while their target audiences are their primary nurses. They will then participate in weekly online meetings with nursing research staff, during which they introduce their stories and discuss their reflections. In the final session, they will create a one-page or five-slide story to share with their primary nurses, if they want.

Behavioral: Nurse-patient dyadic storytelling intervention

Interventions

Nurse-patient dyadic storytelling intervention BEHAVIORAL

During the 5-week online intervention, adolescents/young adults with cancer will create their stories following the guiding questions and online meetings with nursing research staff. The target audience of their stories will be their primary nurses. This online dyadic storytelling intervention is designed to promote in-depth self-reflection and meaningful and therapeutic relationships within bedside nurses. The intervention is designed following the Story Theory and Pennebaker's Expressive Writing paradigm.

Intervention group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms; Narrative Medicine

Condition Hierarchy (Ancestors)

Narration; Communication; Behavior

Study Officials

• Eunji Cho, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctrol Fellow

Model Details: Adolescents/young adults with cancer will participate in a 5-week online expressive storytelling intervention. They will independently create digital stories about themselves while their target audiences are their primary nurses. They will then participate in weekly online meetings with nursing research staff, during which they introduce their stories and discuss their reflections. In the final session, they will create a one-page or five-slide story to share with their primary nurses, if they want.

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: November 10, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available for sharing no later than the publication date of the main results from the final dataset. Data will be disclosed without a specific deadline.
• Access Criteria: The data will be shared with anyone who is interested in this study. We especially seek to make our data available to the community of scientists interested in adolescent and young adult oncology and psychosocial interventions utilizing the power of narratives and nurse-patient therapeutic relationships.

Locations

US (1)