PCRC-Supported Legacy Intervention in Pediatric Palliative Care

NCT04059393 | Completed DMC

• 3 other identifiers: VICC PED 14130NCI-2019-05051R01NR015353
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Giver; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

• Child coping strategies

  Will be measured using the Response to Stress Questionnaire (RSQ). The 57 items are rated from 1-4 indicating frequency of responses to stress, resulting in 5 factors: (a) primary control coping, (b) secondary control coping, (c) disengagement coping, (d) involuntary engagement, and (e) involuntary disengagement. The total score is the total sum of all 57 items, ranging from 57-228. The 5 factor scores are computed as the sum of the appropriate subscales.

  Change between baseline and 2 months post-baseline.

• Child adjustment

  Will be measured using 27-item Pediatric Quality of Life (PedsQL) Inventory Cancer Module to assess child quality of life. We used Child Self-Report versions for ages 5-7, 8-12, and 13-17. Parents completed Parent Proxy-Reports. Items for 7-year-olds were rated on a 3-point Likert scale. Items for children aged 8-17 years and parents were rated on a 5-point Likert scale. Multidimensional scales include pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. Scores are transformed to a 0-100 scale. To calculate scores by dimensions, the mean score = sum of the items over the number of items answered. The total score is the sum of all the items over the number of items answered on all the scales. Higher scores indicate lower problems.

  Change between baseline and 2 months post-baseline.

• Child adjustment

  Will be measured using the Parent-Adolescent Communication Scale (PACS) to assess parent-child communication. Children and parents complete 20-40 items to assess parent-child communication. A total score is calculated ranging from 20-100 with higher scores indicating more positive communication.

  Change between baseline and 2 months post-baseline.

• Parent adjustment

  Will be measured using the Parent-Adolescent Communication Scale (PACS) to assess parent-child communication. Children and parents complete 20-40 items to assess parent-child communication. A total score is calculated ranging from 20-100 with higher scores indicating more positive communication.

  Change between baseline and 2 months post-baseline

• Parent adjustment

  Will be measured using the Adult Self-Report (ASR). The 126-item ASR will assess adaptive functioning and problems. Items are rated on a 3-point Likert scale. Scores in relation to norms for each gender and age are based on national probability samples. Higher scores indicate the item is true for the individual.

  Change between baseline and 2 months post-baseline.

• Parent coping strategies

  Will be measured using the Response to Stress Questionnaire (RSQ). The 57 items are rated from 1-4 indicating frequency of responses to stress, resulting in 5 factors: (a) primary control coping, (b) secondary control coping, (c) disengagement coping, (d) involuntary engagement, and (e) involuntary disengagement. The total score is the total sum of all 57 items, ranging from 57-228. The 5 factor scores are computed as the sum of the appropriate subscales.

  Change between baseline and 2 months post-baseline

Secondary Outcomes (1)

• Parent satisfaction

  Up to 3 months

Study Arms (2)

Group I (web-based legacy intervention)

EXPERIMENTAL

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.

Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Complete web-based legacy intervention

Group I (web-based legacy intervention)

Best Practice OTHER

Receive standard of care

Group II (standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Group I (web-based legacy intervention); Group II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Group I (web-based legacy intervention); Group II (standard of care)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Institute of Nursing Research (NINR): collaborator
• Palliative Care Research Cooperative Group: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• Whitlow ML, Gilmer MJ, Dietrich MS, Cho E, Akard TF. Digital Stories Created by Children With Advanced Cancer. J Pediatr Hematol Oncol Nurs. 2024 Sep-Oct;41(5):336-348. doi: 10.1177/27527530241267296. Epub 2024 Sep 10.

  PMID: 39257031 DERIVED

• 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.

  PMID: 33855995 DERIVED

• 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.

  PMID: 33686901 DERIVED

• 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.

  PMID: 32996842 DERIVED

• 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.

  PMID: 31804281 DERIVED

MeSH Terms

Conditions

Recurrence; Neoplasms

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Terrah Akard, PhD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 16, 2019
• Study Start: July 27, 2015
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)