Pediatric CancerESSAYNCT04855487
Expressive Storytelling to Share Adolescents/Young Adults Cancer Stories
A study testing Nurse-patient dyadic storytelling intervention in people with Pediatric Cancer and Growth, Posttraumatic, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pediatric Cancer, Growth, Posttraumatic, Nurse-Patient Relations
- What is being tested?
- Nurse-patient dyadic storytelling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
[Inclusion Criteria] 1.1 AYA ages 15 to 25 years. Age criterion was determined based on (a) the age criteria of adolescence (15-17 years) and emerging adulthood (18-25 years) guided by lifespan developmental frameworks35 and (b) the intervention being developmentally appropriate for this unique age group.
1.2 Patients must have any type of histologically or cytologically confirmed malignancy during adolescence or young adulthood.
1.3 Patients may be at any stage of the cancer trajectory. Participants can be enrolled beginning one month after an initial cancer diagnosis.
1.4 Patients must be cognitively intact.
1.5 Patients must have access to the internet using their own electronic devices (e.g., laptop, desktop, tablet PC, smartphone).
1.6 Ability to speak, write, read, understand English.
[Exclusion Criteria] 2.1 Patients who have any unanticipated needs that cannot be accommodate by the PI (e.g., technical challenges, permanent loss of electronic devices, permanently unable to access the internet) can be excluded before and during the participation.
2.2 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Expressive Storytelling Intervention for Adolescents and Young Adults With Cancer to Share Stories With Oncology Nurses
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.
Read the detailed 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.
- Being tested
- Nurse-patient dyadic storytelling intervention
- Keywords
- Storytelling, Adolescents and young adults with cancer, Nursing intervention, Human flourishing, Resilience
- Medical subject headings
- Neoplasms, Narrative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-patient dyadic storytelling interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nurse-patient dyadic storytelling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 Nov 2021
- Primary completion30 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Eunji Cho, Vanderbilt University
- Investigators
- Eunji Cho, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855487
- Sponsor's protocol ID
- VR55572
- Acronym
- ESSAY
- Status last verified
- Jun 2022
- First submitted
- 18 Apr 2021
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are no tangible resources to share at this time as the intervention is in testing phases. We plan to make the intervention available for sharing in the future, upon completed testing. Therefore, data is the only resource available for sharing. The proposed research will produce data with 20 adolescent/young adult with cancer. The final data set will contain (a) demographic information, (b) feasibility and acceptability information, and (c) preliminary efficacy of the online expressive storytelling intervention on the well-being in adolescents and young adults with cancer.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Expressive Storytelling Intervention for Adolescents and Young Adults With Cancer to Share Stories With Oncology Nurses
- ClinicalTrials.gov ID
- NCT04855487
- Acronym / sponsor ID
- ESSAY / VR55572
- Keywords
- Storytelling, Adolescents and young adults with cancer, Nursing intervention, Human flourishing, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nurse-patient dyadic storytelling interventionAdolescents/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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-patient dyadic storytelling interventionDuring 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. | Behavioural | Intervention group |
Primary outcome
Change in Secure Flourish Measure (Adolescent Version)
Time frame: Day 0, Day 35
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).
Change in Secure Flourish Measure (Adult Version)
Time frame: Day 0, Day 35
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.
Change in Herth Hope Index Scale
Time frame: Day 0, Day 35
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.
Change in Perceived Social Support from Health Care Professionals
Time frame: Day 0, Day 35
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
Change in Self-transcendence Scale
Time frame: Day 0, Day 35
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
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v. 2.1 (Adult Version)
Time frame: Day 0, Day 35
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
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 25 v. 2.0 (Adolescent Version)
Time frame: Day 0, Day 35
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
Satisfaction Survey
Time frame: Day 35
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.
System Usability Survey
Time frame: Day 35
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Yes. There are no tangible resources to share at this time as the intervention is in testing phases. We plan to make the intervention available for sharing in the future, upon completed testing. Therefore, data is the only resource available for sharing. The proposed research will produce data with 20 adolescent/young adult with cancer. The final data set will contain (a) demographic information, (b) feasibility and acceptability information, and (c) preliminary efficacy of the online expressive storytelling intervention on the well-being in adolescents and young adults with cancer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunji Cho, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-patient dyadic storytelling intervention in people with Pediatric Cancer and Growth, Posttraumatic, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Secure Flourish Measure (Adolescent Version) (time frame: Day 0, Day 35). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.