PCRC-Supported Legacy Intervention in Pediatric Palliative Care

November 14, 2023 updated by: Terrah Akard, Vanderbilt-Ingram Cancer Center

Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (web-based legacy intervention)
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: Quality-of-Life Assessment
Ancillary studies
Other: Questionnaire Administration
Ancillary studies
Other: Internet-Based Intervention
Complete web-based legacy intervention
Active Comparator: Group II (standard of care)
Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.
Other: Quality-of-Life Assessment
Ancillary studies
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child coping strategies
Time Frame: Change between baseline and 2 months post-baseline.
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
Time Frame: Change between baseline and 2 months post-baseline.
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
Time Frame: Change between baseline and 2 months post-baseline.
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
Time Frame: Change between baseline and 2 months post-baseline
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
Time Frame: Change between baseline and 2 months post-baseline.
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
Time Frame: Change between baseline and 2 months post-baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent satisfaction
Time Frame: Up to 3 months
Will be measured using a Follow-up Parent survey that includes multiple choice and open-ended questions related to intervention benefits and suggestions for future research. Counts and frequencies will be reported for parent responses to multiple choice questions. Responses to open-ended questions will undergo thematic content analysis.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Institute of Nursing Research (NINR)
Palliative Care Research Cooperative Group

Investigators

  • Principal Investigator: Terrah Akard, PhD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2015

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 5, 2018

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC PED 14130
  • NCI-2019-05051 (Registry Identifier: NCI, Clinical Trials Reporting Program)
  • R01NR015353 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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