Decision Support Training for Family Caregivers of Cancer Patients

(CASCADE Trial)

Recruiting at 1 trial location

Overseen By Dio Kavalieratos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Mental illness, Dementia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist family caregivers of individuals with newly diagnosed advanced cancer in making better decisions. It tests various training methods for caregivers, including lessons on decision-making, communication skills, and ongoing support. Participants will receive different combinations of training sessions and follow-up calls to determine the most effective approach. This includes the CASCADE Decision Support Training, designed to enhance caregivers' decision-making abilities. Family caregivers supporting someone with advanced cancer may find this trial beneficial. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could improve support for caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the CASCADE Decision Support Training is safe for family caregivers of cancer patients?

Research has shown that decision support training, such as the CASCADE program, is generally safe. In past studies, caregivers who participated in CASCADE completed most sessions without issues. They reported high satisfaction and did not experience major negative effects, suggesting the program is well-received. Participants engaged in activities like social support sessions and communication training, designed to be beneficial and minimize risks. Overall, the training appears safe for those considering joining a similar trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CASCADE program for family caregivers of cancer patients because it provides a comprehensive support system that's not typically available. Unlike standard options that might only offer basic emotional support, CASCADE includes advanced social support, decision-making tools, and communication skills, tailored through both in-person and phone sessions. These features aim to empower caregivers, potentially improving their ability to care for their loved ones and reduce their own stress. By offering structured follow-up calls and personalized guidance, CASCADE seeks to enhance the caregiver experience significantly beyond traditional methods.

What evidence suggests that this trial's treatments could be effective for family caregivers of cancer patients?

Research has shown that training helps caregivers of cancer patients make better decisions. Studies have found that this training increases caregivers' confidence and readiness to make choices. The CASCADE program, offering support and decision-making tools, is being tested across various treatment arms in this trial. Early results suggest that caregivers who complete this program feel more prepared to assist their loved ones. This training aids caregivers in managing the challenges of caring for someone with advanced cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below)

I have a close person who helps me with medical decisions.

I am 21 years old or older.

Exclusion Criteria

I do not have untreated mental health issues, hearing loss, or substance abuse problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Family caregivers receive decision support training through various components such as psychoeducation, communication training, and Ottawa Decision Guide training.

4-6 weeks

1-5 in-person/telephone weekly sessions

Follow-up

Monthly follow-up calls to reinforce training and monitor caregiver and patient outcomes.

24 weeks

1 monthly follow-up call

Extended Follow-up

Participants may continue to receive follow-up calls to further support decision-making skills.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CASCADE

Trial Overview

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.

How Is the Trial Designed?

Group I: Basic social support + monthly follow up calls for 24 weeks Experimental Treatment 1 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 weeks Experimental Treatment 1 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 weeks Experimental Treatment 1 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 call Experimental Treatment 1 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 call Experimental Treatment 1 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 weeks Experimental Treatment 1 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 call Experimental Treatment 1 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 call Experimental Treatment 1 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 weeks Experimental Treatment 1 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 weeks Experimental Treatment 1 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 weeks Experimental Treatment 1 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 call Experimental Treatment 1 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 call Experimental Treatment 1 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 weeks Experimental Treatment 1 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 call Experimental Treatment 1 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 call Experimental Treatment 1 Intervention

3 in-person/telephone weekly sessions on providing social support, and a single monthly follow-up call

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 15 studies found that Decision Support Systems (DSS) were effective in reducing worst and usual pain scores for cancer patients, indicating some benefit in symptom management during and after treatment.

However, DSS interventions showed mixed results for improving overall health-related outcomes like quality of life and depression, highlighting the need for better evaluation methods to understand their full impact on patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. Pitt, E., Bradford, N., Robertson, E., et al.[2023]

In a study involving 189 breast cancer patients, 77% used a patient decision aid (PtDA) designed to help them make informed choices about radiation treatment, indicating a successful implementation of the tool.

Patients were significantly more likely to engage with the PtDA if they received the link through the surgery department and if their treatment report emphasized the need for discussion, highlighting key factors that can enhance PtDA utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a patient decision aid, a process evaluation of a large-scale pre- and post-implementation trial. Raphael Daniela, DB., Russell, NS., van Werkhoven, E., et al.[2021]

A study involving 160 participants, including patients with newly diagnosed breast, advanced-stage prostate, and advanced-stage lung cancer, found that a decision aid significantly improved understanding and involvement in treatment decisions for both patients and their caregivers.

The decision aid facilitated a shared decision-making process, leading to more satisfying treatment choices and highlighting the importance of caregiver involvement in understanding treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capturing treatment decision making among patients with solid tumors and their caregivers. Jones, RA., Steeves, R., Ropka, ME., et al.[2021]

Decision coaching significantly improved the decisional comfort of a breast cancer survivor considering extending endocrine therapy from 8 to 10 years, with scores increasing from 2 to 3 out of 4 after coaching.

The coaching process, guided by an oncology nurse using the Ottawa Decision Support Framework, was rated highly for quality, indicating that such support can help survivors make informed, values-based decisions regarding their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Support for a Woman Considering Continuing Extended Endocrine Therapy for Breast Cancer: A Case Study. Liska, CM., Stacey, D.[2020]

A systematic review of 23 randomized trials found that cancer patient decision aids significantly improve patient participation in decision making and lead to higher-quality decisions regarding treatment options.

Effective strategies to enhance shared decision making include training clinicians, using question prompt sheets, and providing decision coaching, which can help address patients' knowledge gaps and unrealistic expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. Stacey, D., Samant, R., Bennett, C.[2022]

A new curriculum aimed at improving support for oncology family caregivers has been developed and implemented, reaching 154 teams and 322 individuals across 39 states, highlighting the widespread need for better caregiver training.

Initial evaluations of the training courses have been positive, with participants actively setting diverse goals for enhancing family caregiver support in their institutions, indicating a proactive approach to improving caregiver quality of life and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview and evaluation of the oncology family caregiver project: improving quality of life and quality of care for oncology family caregivers. Ferrell, B., Hanson, J., Grant, M.[2022]

The CASCADE trial is a 24-week study involving 352 family caregivers of patients with newly diagnosed advanced cancer, aiming to train caregivers in decision support skills through various intervention components delivered via telehealth.

The primary goal is to reduce patient-reported decisional conflict, while secondary outcomes will assess patient and caregiver distress, healthcare utilization, and quality of life, ultimately identifying the most effective components for decision support in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial. Gazaway, S., Wells, RD., Azuero, A., et al.[2023]

Web-based decision aids (WDAs) significantly reduce cancer decisional conflict and improve knowledge and informed choice among patients, based on a meta-analysis of 24 randomized controlled trials involving 9846 participants.

While WDAs show promise in enhancing decision-making in cancer care, the presence of heterogeneity and quality flaws in the studies suggests that further research is needed to fully understand their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based decision aids for cancer clinical decisions: a systematic review and meta-analysis. Tong, G., Geng, Q., Wang, D., et al.[2021]

A decision aid (DA) designed for women aged 70 and older with Stage I ER+/HER2-negative breast cancer was found to be very helpful, with 94% of participants agreeing it prepared them for treatment decisions.

The DA significantly improved participants' knowledge about their condition, increasing correct responses from an average of 9.0 to 10.6 out of 14 questions, indicating its potential effectiveness in supporting informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a patient decision aid for women aged 70 and older with stage I, estrogen receptor-positive, HER2-negative breast cancer. Minami, CA., Freedman, RA., Karamourtopoulos, M., et al.[2021]

The psychoeducational intervention aimed at improving family caregiver skills was found to be safe and acceptable, with some participants showing improvements in self-efficacy, mental health, anxiety, and depression after the intervention.

However, only 4 out of 9 caregivers completed the program, indicating that the intervention needs refinement to enhance feasibility and adherence among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Family Caregiver Skills Using a Simulation-Based Intervention: A Randomized Pilot Trial. Mazanec, SR., Sandstrom, K., Coletta, D., et al.[2020]

The TRIO Framework was developed to better understand the variable influence and involvement of family caregivers in cancer treatment decision-making, highlighting that this influence can change over time and varies among different caregiver groups.

The framework emphasizes that caregiver involvement is not limited to the immediate decision-making triad but can extend to broader social networks, suggesting that various factors impact how caregivers participate in the decision-making process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TRIO Framework: Conceptual insights into family caregiver involvement and influence throughout cancer treatment decision-making. Laidsaar-Powell, R., Butow, P., Charles, C., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10527385/

Study protocol for the CASCADE factorial trial - PMC

This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04803604

Decision Support Training for Advanced Cancer Family ...

CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase ...

3.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00872

Decision Support Training for Family Caregivers of Patients ...

This phase II trial evaluates decision support training for family caregivers of patients with cancer that may have spread from where it first started to ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0885392421004784

An Early Palliative Care Telehealth Coaching Intervention ...

We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37286131/

Decision support training for advanced cancer family caregivers

This is a 2-site, single-blind, 2 4 factorial trial to test components of the CASCADE decision support training intervention for family caregivers.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8881798/

The CASCADE Pilot Factorial Trial - PMC

Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average ...

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/334491

Decision Support Training for Advanced Cancer Family ...

Using a 2x2x2x2 full factorial design, 256 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one ...