Care GiverNCT04059393
PCRC-Supported Legacy Intervention in Pediatric Palliative Care
A study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Care Giver and Recurrent Malignant Neoplasm, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Care Giver, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
- What is being tested?
- Internet-Based Intervention, Best Practice and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2015to 5 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Internet-Based Intervention, Best Practice, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Complete web-based legacy intervention
Best PracticeOther
Receive standard of care
Quality-of-Life AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between baseline and 2 months post-baseline
Secondary outcomes (1)
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start27 Jul 2015
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Care GiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group
- Responsible party
- Principal investigator, Terrah Akard, Vanderbilt-Ingram Cancer Center
- Investigators
- Terrah Akard, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059393
- Sponsor's protocol ID
- VICC PED 14130
- Other IDs
- NCI-2019-05051, R01NR015353
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39257031Foster 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.
PubMed 33855995Robson 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.
PubMed 33686901Akard 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.
PubMed 32996842Akard 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.
PubMed 31804281
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care
- ClinicalTrials.gov ID
- NCT04059393
- Acronym / sponsor ID
- VICC PED 14130
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (web-based legacy intervention) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (standard of care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionComplete web-based legacy intervention | Other | Group I (web-based legacy intervention) |
| Best PracticeReceive standard of care | Other | Group II (standard of care) |
| Quality-of-Life AssessmentAncillary studies | Other | Group I (web-based legacy intervention), Group II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (web-based legacy intervention), Group II (standard of care) |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Parent satisfaction
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39257031Whitlow 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.
- Derived from this study: PubMed 33855995Foster 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.
- Derived from this study: PubMed 33686901Robson 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.
- Derived from this study: PubMed 32996842Akard 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.
- Derived from this study: PubMed 31804281Akard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrah Akard, PhD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Care Giver and Recurrent Malignant Neoplasm, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child coping strategies (time frame: Change between baseline and 2 months post-baseline.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.