Advanced CancerNCT02666183

Online Information and Support for Distance Caregivers

A study testing Video-C, Nurse Coaching and Web-Only in people with Advanced Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study seeks to test the effectiveness of two arms of an intervention that use videoconference technology for distance caregivers of patients with advanced cancer. The study is significant because the intervention will promote involvement of caregivers of patients with cancer and makes a compelling case for… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Cancer
What is being tested?: Video-C, Nurse Coaching and Web-Only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 397 participants
Where: 1 siteUnited States
Study dates: 6 Apr 2016to 16 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Patient Inclusion Criteria:

a new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage
receives ongoing care from a medical oncologist at the Seidman Cancer Center
Has English as the primary language
Has a life expectancy of >6 months
Provides consent for his/her own treatment and procedures
Identifies a distant care giver (DCG) involved in his/her care, support or planning

Patient Exclusion Criteria:

The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist because the full intervention is tailored to meet the needs of DCGs of patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist

Caregiver Inclusion Criteria

Is an adult family member (at least 18 years old) of a patient with an advanced-stage cancer
Identifies himself/herself as a DCG for the patient
Lives >1 hour travel time away from the patient
Has English as his/her primary language
Is capable of providing informed consent
Will be able to access the internet (phone, computer, etc.)

Caregiver Exclusion Criteria

Cognitive Impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Read the detailed description

The primary goal of this randomized clinical trial is to compare outcomes (anxiety, distress, depression, health status) for distant care givers (DCGs) of patients with advanced cancer who are randomly assigned to either the full intervention arm (Closer), the video-only intervention arm (Video-C Only) or the control group (Web-Only). the goal is to determine which is most efficacious in improving outcomes over time for these caregivers. In addition, this study will examine the indirect effects of each arm of the intervention on DCG outcomes over time as well as explore the nature of relationships between patient and DCG distress, anxiety and depression over time.

The specific research questions include:

Is there a difference in DCG outcomes (anxiety, distress, depression, health status) over time between caregivers in the Closer, Video-C Only, and Web-Only groups, controlling for DCG demographic variables?
Are there significant indirect effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, distress, depression, health status) over time, controlling for DCG demographic variables?
Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Conditions: Advanced Cancer
Being tested: Video-C, Nurse Coaching, Web-Only
Keywords: cancer, caregiver, videoconferencing
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Video-CBehavioural
Also called Video Conferencing
use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse CoachingBehavioural
structured conversations with registered nurses aimed at providing emotional support
Web-OnlyBehavioural
Access to a website with caregiving resources, resources for distant care givers, and cancer information

Study groups in NCT02666183
Study group	Role	What they receive
Closer	Experimental	The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired. Receives: Behavioral: Video-C; Behavioral: Nurse Coaching
Video-C Only	Active comparator	This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG. Receives: Behavioral: Video-C
Web-Only	Active comparator	This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention. Receives: Behavioral: Web-Only

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Anxiety T-scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety.
The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety.
The mean and standard deviation are as follows: M=50 (SD=10).
T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and > 70 represent severe anxiety.
Measured: At enrollment to end of intervention period (4 months)
Change in Distress Scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population.
The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.
Scores range from 0 to 10 with higher scores representing higher levels of distress.
Scores >4 indicate distress requiring further evaluation.
Measured: At enrollment to end of intervention period (4 months)
Change in Depression T-scores
Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a.
The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression.
T-scores from 55-60 represent mild depression, 61-70 moderate depression and > 70 represent severe depression.
Measured: At enrollment to end of intervention period (4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 201616 Apr 2020

First posted28 Jan 2016 (estimated)
Study start6 Apr 2016
Primary completion16 Apr 2020
Study completion16 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 397 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02666183
Sponsor's protocol ID: CASE6Y15
Status last verified: Feb 2022
First submitted: 21 Jan 2016
Last updated: 22 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Blackstone E, Lipson AR, Douglas SL. Closer: A videoconference intervention for distance caregivers of cancer patients. Res Nurs Health. 2019 Aug;42(4):256-263. doi: 10.1002/nur.21952. Epub 2019 May 22.
PubMed 31119765
Douglas SL, Mazanec P, Lipson AR, Day K, Blackstone E, Bajor DL, Saltzman J, Krishnamurthi S. Videoconference Intervention for Distance Caregivers of Patients With Cancer: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Jan;17(1):e26-e35. doi: 10.1200/OP.20.00576.
PubMed 33434451
Blackstone E, Douglas SL, Lipson AR. Videoconferencing Empowers Distance Caregivers to Be More Involved in Care. Oncol Nurs News. 2019 Jan-Feb;13(1):https://www.oncnursingnews.com/view/videoconferencing-empowers-distance-caregivers-to-be-more-involved-in-care. Epub 2019 Feb 8.
PubMed 35782672
Douglas SL, Mazanec P, Lipson AR, Blackstone E, Day K, Bajor DL, Krishnamurthi SS. Video conference intervention for distance caregivers (DCGs) of patients with cancer: Improving psychological outcomes. Journal of Clinical Oncology. 2020; 38:15 (supplement); 12123.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Online Information and Support for Distance Caregivers
ClinicalTrials.gov ID: NCT02666183
Acronym / sponsor ID: CASE6Y15
Conditions: Advanced Cancer
Keywords: cancer, caregiver, videoconferencing
Study type: Interventional
Recruitment status: Completed
Enrolment: 397 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: 6 Apr 2016 (actual)
Primary completion: 16 Apr 2020 (actual)
Study completion: 16 Apr 2020 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Posted 21 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific research questions include:

Is there a difference in DCG outcomes (anxiety, distress, depression, health status) over time between caregivers in the Closer, Video-C Only, and Web-Only groups, controlling for DCG demographic variables?
Are there significant indirect effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, distress, depression, health status) over time, controlling for DCG demographic variables?
Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 3

Arm	Type	Receives
Closer	Experimental	Behavioral: Video-C, Behavioral: Nurse CoachingThe full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C Only	Active comparator	Behavioral: Video-CThis arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Web-Only	Active comparator	Behavioral: Web-OnlyThis group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
Video-CAlso: Video Conferencinguse videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers	Behavioural	Closer, Video-C Only
Nurse Coachingstructured conversations with registered nurses aimed at providing emotional support	Behavioural	Closer
Web-OnlyAccess to a website with caregiving resources, resources for distant care givers, and cancer information	Behavioural	Web-Only

Primary outcome

Change in Anxiety T-scores
Time frame: At enrollment to end of intervention period (4 months)
Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety. The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety. The mean and standard deviation are as follows: M=50 (SD=10). T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and > 70 represent severe anxiety.
Change in Distress Scores
Time frame: At enrollment to end of intervention period (4 months)
Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population. The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scores range from 0 to 10 with higher scores representing higher levels of distress. Scores >4 indicate distress requiring further evaluation.
Change in Depression T-scores
Time frame: At enrollment to end of intervention period (4 months)
Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression. T-scores from 55-60 represent mild depression, 61-70 moderate depression and > 70 represent severe depression.

Results and safety

Results posted to the registry on 21 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Closer	137	103
Video-C Only	141	106
Web-Only	119	93

Primary outcome: Change in Anxiety T-scores

Time frame: At enrollment to end of intervention period (4 months). Mean (Standard Deviation). Unit: T-score

Measure	Closer n = 103	Video-C Only n = 106	Web-Only n = 93
Value	53.14 (8.14)	55.47 (7.67)	56.85 (8.73)

Closer vs Video-C Only: Estimated marginal mean difference: -2.251 (95% CI -5.051 to 0.550), p = 0.162, ANCOVA
Closer vs Web-Only: Estimated marginal mean difference: -3.663 (95% CI -6.538 to -0.789), p = 0.007, ANCOVA
Video-C Only vs Web-Only: Estimated marginal mean difference: -1.413 (95% CI -4.290 to 1.464), p = 0.714, ANCOVA

Primary outcome: Change in Distress Scores

Time frame: At enrollment to end of intervention period (4 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Closer n = 103	Video-C Only n = 106	Web-Only n = 93
Value	3.37 (2.80)	3.89 (2.64)	4.86 (2.66)

Closer vs Video-C Only: Estimated marginal mean difference: -0.531 (95% CI -1.297 to 0.234), p = 0.173, ANCOVA
Closer vs Web-Only: Estimated marginal mean difference: -1.456 (95% CI -2.241 to -0.671), p = 0.001, ANCOVA
Video-C Only vs Web-Only: Estimated marginal mean difference: -0.925 (95% CI -1.711 to -0.139), p = 0.021, ANCOVA

Primary outcome: Change in Depression T-scores

Time frame: At enrollment to end of intervention period (4 months). Mean (Standard Deviation). Unit: T-score

Measure	Closer n = 103	Video-C Only n = 106	Web-Only n = 93
Value	49.29 (8.00)	50.72 (7.89)	52.62 (8.75)

Closer vs Video-C Only: Estimated marginal mean difference: -0.984 (95% CI -2.939 to 0.971), p = 0.323, ANCOVA
Closer vs Web-Only: Estimated marginal mean difference: -1.768 (95% CI -3.785 to 0.249), p = 0.086, ANCOVA
Video-C Only vs Web-Only: Estimated marginal mean difference: -0.784 (95% CI -2.794 to 1.226), p = 0.443, ANCOVA

Adverse events

Time frame: Adverse event data were collected throughout study period (6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Closer	0 of 103 (0%)	0 of 103 (0%)	0 of 103
Video-C Only	0 of 106 (0%)	0 of 106 (0%)	0 of 106
Web-Only	0 of 93 (0%)	0 of 93 (0%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31119765Blackstone E, Lipson AR, Douglas SL. Closer: A videoconference intervention for distance caregivers of cancer patients. Res Nurs Health. 2019 Aug;42(4):256-263. doi: 10.1002/nur.21952. Epub 2019 May 22.
Results publication: PubMed 33434451Douglas SL, Mazanec P, Lipson AR, Day K, Blackstone E, Bajor DL, Saltzman J, Krishnamurthi S. Videoconference Intervention for Distance Caregivers of Patients With Cancer: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Jan;17(1):e26-e35. doi: 10.1200/OP.20.00576.
Results publication: PubMed 35782672Blackstone E, Douglas SL, Lipson AR. Videoconferencing Empowers Distance Caregivers to Be More Involved in Care. Oncol Nurs News. 2019 Jan-Feb;13(1):https://www.oncnursingnews.com/view/videoconferencing-empowers-distance-caregivers-to-be-more-involved-in-care. Epub 2019 Feb 8.
Results publicationDouglas SL, Mazanec P, Lipson AR, Blackstone E, Day K, Bajor DL, Krishnamurthi SS. Video conference intervention for distance caregivers (DCGs) of patients with cancer: Improving psychological outcomes. Journal of Clinical Oncology. 2020; 38:15 (supplement); 12123.

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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.

Sara Douglas, RN, PhD principal investigator

University Hospitals Cleveland Medical Center, Case Comprehensive 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 Video-C, Nurse Coaching and Web-Only in people with Advanced Cancer, run by Case Comprehensive 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?

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 22 Feb 2022. 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?

Yes. Results are posted in the registry (first posted 21 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Anxiety T-scores (time frame: At enrollment to end of intervention period (4 months)). The study lists 3 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 NCT02666183, which also lists 4 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 22 Feb 2022.