Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date May 1, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 25 Years
Eligibility [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.

Study Design


Intervention

Behavioral:
Nurse-patient dyadic storytelling intervention
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.

Locations

Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Withdrawn NCT04719416 - Relaxation Therapy in Pediatric Oncology N/A
Completed NCT01645436 - Physical Activity in Pediatric Cancer (PAPEC) N/A
Completed NCT04409301 - Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation N/A
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05425043 - Granulocyte Transfusions After Umbilical Cord Blood Transplant N/A
Recruiting NCT05071859 - Genetic Overlap Between Anomalies and Cancer in Kids in the Children's Oncology Group: The COG GOBACK Study
Recruiting NCT03241251 - Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
Recruiting NCT05384288 - Response to Influenza Vaccination in Pediatric Oncology Patients
Completed NCT04586491 - The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients N/A
Recruiting NCT05569512 - Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML Phase 1/Phase 2
Enrolling by invitation NCT05294380 - Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
Completed NCT02665819 - Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility. N/A
Completed NCT02675166 - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Terminated NCT02536183 - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Phase 1
Withdrawn NCT01828502 - Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer Phase 2
Completed NCT02032121 - Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors N/A
Completed NCT03964259 - Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia Phase 1