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Completed

NCT Number: NCT04059393

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.

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Key information

Conditions

Care Giver Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Malignant Neoplasm Refractory Malignant Neoplasm

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Intervention

Other

Complete web-based legacy intervention

Best Practice

Other

Receive standard of care

Quality-of-Life Assessment

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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