Advanced Malignant NeoplasmNCT02650583
Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children
A study testing Educational Intervention and Questionnaire Administration in people with Advanced Malignant Neoplasm, run by University of Washington at 1 site in United States.
Trial summary
This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- Educational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2015to 15 Feb 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents will be eligible if they have a diagnosis of incurable cancer of any type
- Read and write English among their languages of choice
- Have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
- The child does not have learning challenges
Who cannot join
- Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
- Parents will be ineligible if their child lives in the home less than 50% of the time
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Enhancing Connections Program in Palliative Care: Taking Care of the Children
This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the feasibility of the study protocol in advanced cancer patients (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).
II. To evaluate the short-term impact of the program on the diagnosed parents' and children's adjustment using a within group design (pre- and post-test design).
III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from the completed Phase III trial (between group design).
OUTLINE:
Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- Educational Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive Enhancing Connections Program
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Enhancing Connections Program) | Experimental | Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention
Baseline scores will be compared with post-intervention scores on the same measures. Analysis of covariance will be used to test for significant differences between pre- and post-test scores.
Measured: Baseline to up to 3 months
Differences between the telephone-delivered and the in-person delivered program
Linear mixed modeling based on maximum likelihood estimation will be used to test the differences between the telephone-delivered and the in-person delivered program.
Measured: Up to 3 months
Dosage and fidelity
Will be monitored for each intervention session using the performance checklists, the same checklists used to monitor dosage and fidelity in the Enhancing Connections (EC) trial. (Each session of the Program has its own unique Performance Checklist and each item is scored from 0-2. Performance Checklist items are specific to each session of the Program to be delivered by the patient educator. Higher scores denote higher performance by the patient educator and greater confidence that the Program was delivered as designed. The Performance Checklist is only used to monitor the performance of the
Measured: Up to 3 months
Duration of intervention sessions
Measured: Up to 3 months
Number of patients recruited and retained, tracked on recruitment spreadsheets
Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter.
Measured: Up to 3 months
Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire
Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).
Measured: Up to 3 months
Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data
Assessed at baseline and post-intervention (up to 3 months).
Measured: Up to 3 months
Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt
Assessed at baseline and post-intervention (up to 3 months).
Measured: Up to 14 weeks
Program acceptability (per session, overall, duration of program, interval between intervention sessions)
Will be assessed from a debriefing interview in Session 5 that includes the parents' attributed gains of the program and their responses to the program's content, format, in-session, and at-home assignments.
Measured: At Session 5, occurring within up to 3 months
Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)
Measured: Baseline
Rate of success in scheduling and completing intervention sessions
Measured: At Session 5, occurring within 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 posted8 Jan 2016 (estimated)
- Study start28 Dec 2015
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frances Lewis, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650583
- Sponsor's protocol ID
- 9480
- Other IDs
- NCI-2015-01941, 9480, P30CA015704
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Connections Program in Palliative Care: Taking Care of the Children
- ClinicalTrials.gov ID
- NCT02650583
- Acronym / sponsor ID
- 9480
- Conditions
- Advanced Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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 pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.
Detailed description
PRIMARY OBJECTIVES:
- To test the feasibility of the study protocol in advanced cancer patients (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).
II. To evaluate the short-term impact of the program on the diagnosed parents' and children's adjustment using a within group design (pre- and post-test design).
III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from the completed Phase III trial (between group design).
OUTLINE:
Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Enhancing Connections Program) | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationPatients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parents will be eligible if they have a diagnosis of incurable cancer of any type
- Read and write English among their languages of choice
- Have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
- The child does not have learning challenges
Key exclusion criteria (2 listed)
- Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
- Parents will be ineligible if their child lives in the home less than 50% of the time
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive Enhancing Connections Program | Other | Supportive care (Enhancing Connections Program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (Enhancing Connections Program) |
Primary outcome
Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention
Time frame: Baseline to up to 3 months
Baseline scores will be compared with post-intervention scores on the same measures. Analysis of covariance will be used to test for significant differences between pre- and post-test scores.
Differences between the telephone-delivered and the in-person delivered program
Time frame: Up to 3 months
Linear mixed modeling based on maximum likelihood estimation will be used to test the differences between the telephone-delivered and the in-person delivered program.
Dosage and fidelity
Time frame: Up to 3 months
Will be monitored for each intervention session using the performance checklists, the same checklists used to monitor dosage and fidelity in the Enhancing Connections (EC) trial. (Each session of the Program has its own unique Performance Checklist and each item is scored from 0-2. Performance Checklist items are specific to each session of the Program to be delivered by the patient educator. Higher scores denote higher performance by the patient educator and greater confidence that the Program was delivered as designed. The Performance Checklist is only used to monitor the performance of the
Duration of intervention sessions
Time frame: Up to 3 months
Number of patients recruited and retained, tracked on recruitment spreadsheets
Time frame: Up to 3 months
Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter.
Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire
Time frame: Up to 3 months
Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).
Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data
Time frame: Up to 3 months
Assessed at baseline and post-intervention (up to 3 months).
Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt
Time frame: Up to 14 weeks
Assessed at baseline and post-intervention (up to 3 months).
Program acceptability (per session, overall, duration of program, interval between intervention sessions)
Time frame: At Session 5, occurring within up to 3 months
Will be assessed from a debriefing interview in Session 5 that includes the parents' attributed gains of the program and their responses to the program's content, format, in-session, and at-home assignments.
Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)
Time frame: Baseline
Rate of success in scheduling and completing intervention sessions
Time frame: At Session 5, occurring within 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 15 Feb 2019.
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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.
Frances Lewis principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Questionnaire Administration in people with Advanced Malignant Neoplasm, run by University of Washington 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 4 inclusion and 2 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 15 Feb 2019. 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?
Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention (time frame: Baseline to up to 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.