Clinical trial NCT04059393: PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Official title: Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Giver
Recurrent Malignant Neoplasm
Refractory Malignant Neoplasm
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Palliative Care Research Cooperative Group
First posted: 2019-08-16
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well a web-based legacy intervention works in improving the quality of life in caregivers and younger patients with cancer that has come back (recurrent) or does not respond to treatment (refractory). Legacy-making, defined as doing or saying something to be remembered, may reduce the suffering of children with cancer and their caregivers. Currently, there is little information about what kinds of legacy-making activities are helpful from the perspective of children. Using a web-based digital storytelling intervention, this study may help researchers examine what children think about these legacy-making activities and what kinds of activities might be helpful to them.

Detailed description: PRIMARY OBJECTIVES:

I. To examine the impact of legacy-making on coping strategies and adjustment outcomes among children with refractory or relapsed cancer.

II. To examine the impact of legacy-making on coping strategies and adjustment outcomes among parent caregivers.

III. To examine the process of implementing a web-based legacy-making intervention for children with refractory or relapsed cancer and their parent caregivers by obtaining parent self-reports (e.g., What did you and your child-like/not like about the intervention? How difficult was it to complete the intervention? What made it difficult? What else you would like to teach us?).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in a web-based legacy intervention by answering questions about themselves and uploading videos, photographs, and music to create a digital story within 2 weeks.

GROUP II: Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.

Eligibility criteria: Inclusion Criteria:

* Children ages 7-17 years will be included so the sample will reflect similar developmental understandings that death is permanent and universal. Ages 18 and up are excluded because they begin very different developmental stages of independence as they often leave home and begin college and careers. The principal investigator (PI) or trained clinical trials associate (CTA) will determine the primary parent caregiver by gathering objective information (e.g., number of hours spent per week with the child) from the child's legal guardian during the initial recruitment process
* Relapsed or refractory cancer disease states: This will be determined by parent self-report. This determination will be made at any point within the illness trajectory
* Able to speak, understand, read, and type English: Participants will be limited to those who meet this criterion because the instruments and methods proposed in this research have not been translated in foreign languages
* Participants will be limited to those who have internet access to allow us to successfully examine the feasibility of a web-based intervention
* Absence of cognitive impairment: Cognitive impairment will be determined by the PI or CTA during the consent process. If the child or parent does not understand the consent process (e.g., does not understand project goal, does not understand study procedures), the PI or CTA will gently conclude the recruitment process. Any data already collected will not be included in data analysis, and the participant will be considered withdrawn

Primary outcomes:
measure: Child coping strategies
timeFrame: Change between baseline and 2 months post-baseline.
measure: Child adjustment
timeFrame: Change between baseline and 2 months post-baseline.
measure: Child adjustment
timeFrame: Change between baseline and 2 months post-baseline.
measure: Parent adjustment
timeFrame: Change between baseline and 2 months post-baseline
measure: Parent adjustment
timeFrame: Change between baseline and 2 months post-baseline.
measure: Parent coping strategies
timeFrame: Change between baseline and 2 months post-baseline
Secondary outcomes:
measure: Parent satisfaction
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Terrah Akard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foster Akard T, Dietrich MS, Friedman DL, Wray S, Gerhardt CA, Given B, Hendricks-Ferguson VL, Hinds PS, Cho E, Gilmer MJ. Effects of a Web-Based Pediatric Oncology Legacy Intervention on Parental Coping. Oncol Nurs Forum. 2021 May 1;48(3):309-316. doi: 10.1188/21.ONF.309-316.
citation: Robson PC, Dietrich MS, Akard TF. Associations of Age, Gender, and Family Income with Quality of Life in Children With Advanced Cancer. J Pediatr Oncol Nurs. 2021 Jul-Aug;38(4):254-261. doi: 10.1177/1043454221992321. Epub 2021 Mar 9.
citation: Akard TF, Dietrich MS, Friedman DL, Wray S, Gerhardt CA, Hendricks-Ferguson V, Hinds PS, Rhoten B, Gilmer MJ. Randomized Clinical Trial of a Legacy Intervention for Quality of Life in Children with Advanced Cancer. J Palliat Med. 2021 May;24(5):680-688. doi: 10.1089/jpm.2020.0139. Epub 2020 Sep 30.
citation: Akard TF, Wray S, Friedman DL, Dietrich MS, Hendricks-Ferguson V, Given B, Gerhardt CA, Hinds PS, Gilmer MJ. Transforming a Face-to-Face Legacy Intervention to a Web-Based Legacy Intervention for Children With Advanced Cancer. J Hosp Palliat Nurs. 2020 Feb;22(1):49-60. doi: 10.1097/NJH.0000000000000614.