Online Information and Support for Distance Caregivers

NCT02666183 | Completed Results

• 1 other identifier: CASE6Y15
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

Brief 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 significance based on changing demographics and lifestyles.

Conditions

Advanced Cancer

Keywords

cancer; caregiver; videoconferencing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At enrollment to end of intervention period (4 months)

Study Arms (3)

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.

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.

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.

Behavioral: Web-Only

Interventions

Video-C BEHAVIORAL

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

Also known as: Video Conferencing

Closer; Video-C Only

Nurse Coaching BEHAVIORAL

structured conversations with registered nurses aimed at providing emotional support

Closer

Web-Only BEHAVIORAL

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

Web-Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)
• Cognitive Impairment

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

• 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.

  PMID: 31119765 BACKGROUND

• 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.

  PMID: 33434451 RESULT

• 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.

  PMID: 35782672 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Sara L. Douglas, PhD, RN, Professor FPB School of Nursing
• Organization: Case Western Reserve University

sld4@case.edu

216-368-0702

Study Officials

• Sara Douglas, RN, PhD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Study personnel administering questionnaire and follow-up questions with participants will be blinded to the arm assignment of the participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 28, 2016
• Study Start: April 6, 2016
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: February 22, 2022
• Results First Posted: January 21, 2022

Record last verified: 2022-02

Locations

US (1)