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N/A N=397 Randomized Single-blind Supportive Care

Online Information and Support for Distance Caregivers

Advanced Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02666183 ↗
Enrolled (actual)
397
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Anxiety T-scores — 53.14; 55.47; 56.85 T-score — p=0.162

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Video-C (Behavioral); Nurse Coaching (Behavioral); Web-Only (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Case Comprehensive Cancer Center
Primary completion
Apr 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Anxiety T-scores		 53.14; 55.47; 56.85 0.162
PRIMARY
Change in Distress Scores		 3.37; 3.89; 4.86 0.173
PRIMARY
Change in Depression T-scores		 49.29; 50.72; 52.62 0.323

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02666183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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