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Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial (CASCADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803604
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : June 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
James N Dionne-Odom, University of Alabama at Birmingham

Brief Summary:
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 352 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

Condition or disease Intervention/treatment Phase
Family Members Cancer Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners) Phase 3

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2x2x2 full factorial pilot randomized trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the lay coach involved in delivering the intervention.
Primary Purpose: Supportive Care
Official Title: Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Basic social support + communication + Ottawa guide + 1 monthly follow up call
3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + communication + Ottawa guide + monthly follow up calls for 24 weeks
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
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + communication + 1 monthly follow up call
2 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + communication + monthly follow up calls for 24 weeks
2 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + Ottawa guide + 1 monthly follow up call
2 in-person/telephone weekly sessions on 1 coaching session on providing social support, decision support tools, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + Ottawa guide + monthly follow up calls for 24 weeks
2 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + 1 monthly follow up call
1 in-person/telephone weekly sessions on providing social support and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Basic social support + monthly follow up calls for 24 weeks
1 in-person/telephone weekly sessions on providing social support and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + communication + Ottawa guide + 1 monthly follow up call
5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + communication + Ottawa guide + monthly follow up calls for 24 weeks
5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + communication + 1 monthly follow up call
4 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + communication + monthly follow up calls for 24 weeks
4 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + Ottawa guide + 1 monthly follow up call
4 in-person/telephone weekly sessions on providing social support, decision support tools, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + Ottawa guide + monthly follow up calls for 24 weeks
4 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + 1 monthly follow up call
3 in-person/telephone weekly sessions on providing social support, and a single monthly follow-up call
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

Experimental: Advanced social support + monthly follow up calls for 24 weeks
3 in-person/telephone weekly sessions on providing social support, and monthly follow-up calls for 6 months
Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.




Primary Outcome Measures :
  1. Patient reported decisional conflict using the Decisional Conflict Scale [ Time Frame: Baseline to 24 weeks ]
    16-item measure; perceptions of uncertainty in choosing options, factors contributing to uncertainty (e.g., feeling uninformed, unclear values) and feeling that decisions were informed and values-based.


Secondary Outcome Measures :
  1. Patient distress as measured by the Hospital Anxiety and Depression Scale [ Time Frame: Baseline to 24 weeks ]
    14 items total, 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.

  2. Patient quality of life as measured by the PROMIS Global Health 10 [ Time Frame: Baseline to 24 weeks ]
    10 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness. Higher scores=higher HRQOL.

  3. Patient healthcare utilization including advance directive completion as reported by family caregivers [ Time Frame: Baseline to 24 weeks ]
    Inpatient days, ICU days, ED visits, urgent care visits, hospice use, palliative care provider visits, advance care planning conversations, advance directive completion, DNR orders

  4. Caregiver distress as measured by the Hospital Anxiety and Depression Scale [ Time Frame: Baseline to 24 weeks ]
    14 items total, 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.

  5. Caregiver quality of life as measured by the PROMIS Global Health 10 [ Time Frame: Baseline to 24 weeks ]
    0 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness. Higher scores=higher HRQOL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

FAMILY CAREGIVERS

Inclusion Criteria:

  1. ≥21 years of age;
  2. self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
  3. caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below);
  4. caregivers will need to have an agreeable patient willing to participate in the study for data collection; and
  5. English-speaking and able to complete baseline measures.

Exclusion Criteria:

1) Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

PATIENTS

Inclusion Criteria:

  1. ≥21 years of age;
  2. diagnosed within 60 days of initial screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma, and hematologic malignancies.

Exclusion Criteria:

1) Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803604


Contacts
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Contact: Peggie McKie, MPH 205-996-0196 bellpm@uab.edu
Contact: Sally Engler, MPH 205-996-7564 sengler@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Peggy McKie, MPH    205-996-0196    bellpm@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
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Responsible Party: James N Dionne-Odom, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04803604    
Other Study ID Numbers: R01CA262039 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James N Dionne-Odom, University of Alabama at Birmingham:
family caregiver
decision-making
multiphase optimization strategy
factorial trial