Back to resultsPCRC-Supported Legacy Intervention in Pediatric Palliative Care
Primary Purpose
Care Giver, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Best Practice
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Care Giver
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 Any data already collected will not be included in data analysis, and the participant will be considered withdrawn
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (web-based legacy intervention)
Group II (standard of care)
Arm Description
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.
Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Parent satisfaction
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.
Full Information
NCT ID
NCT04059393
First Posted
August 8, 2019
Last Updated
January 28, 2023
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group
1. Study Identification
Unique Protocol Identification Number
NCT04059393
Brief Title
PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Official Title
Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Care Giver, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (web-based legacy intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Complete web-based legacy intervention
Intervention Type
Other
Intervention Name(s)
Best Practice
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Child coping strategies
Description
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.
Time Frame
Change between baseline and 2 months post-baseline.
Title
Child adjustment
Description
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.
Time Frame
Change between baseline and 2 months post-baseline.
Title
Child adjustment
Description
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.
Time Frame
Change between baseline and 2 months post-baseline.
Title
Parent adjustment
Description
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.
Time Frame
Change between baseline and 2 months post-baseline
Title
Parent adjustment
Description
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.
Time Frame
Change between baseline and 2 months post-baseline.
Title
Parent coping strategies
Description
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.
Time Frame
Change between baseline and 2 months post-baseline
Secondary Outcome Measure Information:
Title
Parent satisfaction
Description
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.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrah Akard, PhD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33855995
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.
Results Reference
derived
PubMed Identifier
33686901
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.
Results Reference
derived
PubMed Identifier
32996842
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.
Results Reference
derived
PubMed Identifier
31804281
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.
Results Reference
derived
Learn more about this trial
PCRC-Supported Legacy Intervention in Pediatric Palliative Care
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