Online Information and Support for Distance Caregivers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-06

Study Completion Date

2020-04-16

Brief Summary

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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 significance based on changing demographics and lifestyles.

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Detailed Description

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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:

1. 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?
2. 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?
3. Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study personnel administering questionnaire and follow-up questions with participants will be blinded to the arm assignment of the participant

Study Groups

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Closer

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.

Group Type EXPERIMENTAL

Video-C

Intervention Type BEHAVIORAL

use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers

Nurse Coaching

Intervention Type BEHAVIORAL

structured conversations with registered nurses aimed at providing emotional support

Video-C Only

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.

Group Type ACTIVE_COMPARATOR

Video-C

Intervention Type BEHAVIORAL

use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers

Web-Only

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.

Group Type ACTIVE_COMPARATOR

Web-Only

Intervention Type BEHAVIORAL

Access to a website with caregiving resources, resources for distant care givers, and cancer information

Interventions

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Video-C

use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers

Intervention Type BEHAVIORAL

Nurse Coaching

structured conversations with registered nurses aimed at providing emotional support

Intervention Type BEHAVIORAL

Web-Only

Access to a website with caregiving resources, resources for distant care givers, and cancer information

Intervention Type BEHAVIORAL

Other Intervention Names

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Video Conferencing

Eligibility Criteria

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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

* 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.)

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

* Cognitive Impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes