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Behavioral Intervention

Decision Support Training for Family Caregivers of Cancer Patients (CASCADE Trial)

Phase 3
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English-speaking and able to complete baseline measures
≥21 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

CASCADE Trial Summary

This trial is testing a new way to help family caregivers of people with cancer make decisions, by coaching them through different aspects of decision making.

Who is the study for?
This trial is for English-speaking adults over 21 who are family caregivers to someone with newly-diagnosed advanced cancer. The caregiver must be involved in the patient's medical decisions and have a patient willing to participate. Those with mental illness, dementia, suicidal thoughts, hearing loss, or substance abuse cannot join.Check my eligibility
What is being tested?
The CASCADE trial tests training methods to improve decision support skills of caregivers. It uses a complex design (2x2x2x2 factorial) to see which combination of psychoeducation sessions, communication training, and Ottawa Decision Guide training works best over up to six months.See study design
What are the potential side effects?
Since this intervention involves educational and support components rather than medication or medical procedures, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses related to the content.

CASCADE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I speak English and can complete initial health assessments.
Select...
I am 21 years old or older.
Select...
I am 21 years old or older.

CASCADE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient reported decisional conflict using the Decisional Conflict Scale
Secondary outcome measures
Caregiver distress as measured by the Hospital Anxiety and Depression Scale
Caregiver quality of life as measured by the PROMIS Global Health 10
Patient distress as measured by the Hospital Anxiety and Depression Scale
+2 more

CASCADE Trial Design

16Treatment groups
Experimental Treatment
Group I: Basic social support + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
1 in-person/telephone weekly sessions on providing social support and monthly follow-up calls for 6 months
Group II: Basic social support + communication + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months
Group III: Basic social support + communication + Ottawa guide + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6 months
Group IV: Basic social support + communication + Ottawa guide + 1 monthly follow up callExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call
Group V: Basic social support + communication + 1 monthly follow up callExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call
Group VI: Basic social support + Ottawa guide + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months
Group VII: Basic social support + Ottawa guide + 1 monthly follow up callExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on 1 coaching session on providing social support, decision support tools, and a single monthly follow-up call
Group VIII: Basic social support + 1 monthly follow up callExperimental Treatment1 Intervention
1 in-person/telephone weekly sessions on providing social support and a single monthly follow-up call
Group IX: Advanced social support + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support, and monthly follow-up calls for 6 months
Group X: Advanced social support + communication + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months
Group XI: Advanced social support + communication + Ottawa guide + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6
Group XII: Advanced social support + communication + Ottawa guide + 1 monthly follow up callExperimental Treatment1 Intervention
5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call
Group XIII: Advanced social support + communication + 1 monthly follow up callExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call
Group XIV: Advanced social support + Ottawa guide + monthly follow up calls for 24 weeksExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months
Group XV: Advanced social support + Ottawa guide + 1 monthly follow up callExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support, decision support tools, and a single monthly follow-up call
Group XVI: Advanced social support + 1 monthly follow up callExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support, and a single monthly follow-up call
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CASCADE (CAre Supporters Coached to be Adept DEcision partners)
2019
N/A
~100

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,130 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,502 Total Patients Enrolled

Media Library

CASCADE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04803604 — Phase 3
Cancer Research Study Groups: Advanced social support + monthly follow up calls for 24 weeks, Advanced social support + Ottawa guide + 1 monthly follow up call, Advanced social support + 1 monthly follow up call, Basic social support + Ottawa guide + monthly follow up calls for 24 weeks, Advanced social support + communication + 1 monthly follow up call, Advanced social support + communication + monthly follow up calls for 24 weeks, Basic social support + 1 monthly follow up call, Basic social support + monthly follow up calls for 24 weeks, Advanced social support + communication + Ottawa guide + 1 monthly follow up call, Advanced social support + communication + Ottawa guide + monthly follow up calls for 24 weeks, Advanced social support + Ottawa guide + monthly follow up calls for 24 weeks, Basic social support + communication + Ottawa guide + 1 monthly follow up call, Basic social support + communication + Ottawa guide + monthly follow up calls for 24 weeks, Basic social support + communication + 1 monthly follow up call, Basic social support + communication + monthly follow up calls for 24 weeks, Basic social support + Ottawa guide + 1 monthly follow up call
Cancer Clinical Trial 2023: CASCADE Highlights & Side Effects. Trial Name: NCT04803604 — Phase 3
CASCADE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803604 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with CASCADE for patients?

"CASCADE (CAre Supporters Coached to be Adept DEcision partners) has received a score of 3 for safety. This is due to this being a Phase 3 trial, where there is not only data supporting efficacy, but also multiple rounds of data affirming safety."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
James N Dionne-Odom 2022. "Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803604.
~173 spots leftby Jun 2026
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