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

Trial Summary

What is the purpose of this trial?

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, 256 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).

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 data supports the effectiveness of the treatment CASCADE Decision Support Training for family caregivers of cancer patients?

Research shows that training caregivers in decision support can improve the quality of decisions made by cancer patients. Studies on similar decision aids have found that they help patients participate more in decision making and make better-informed choices. ^{1 2 3 4 5}

Is the CASCADE Decision Support Training safe for family caregivers of cancer patients?

The available research does not provide specific safety data for the CASCADE Decision Support Training, but decision aids and support systems in general are designed to help with decision-making and are not known to pose safety risks to participants. ^{1 3 4 6 7}

What makes the CASCADE Decision Support Training unique compared to other treatments for cancer patients?

The CASCADE Decision Support Training is unique because it focuses on training family caregivers to provide effective decision support to cancer patients, enhancing their ability to assist in treatment decisions. Unlike traditional treatments that target the patient directly, this intervention empowers caregivers with skills to improve decision-making processes, making it a novel approach in cancer care. ^{1 8 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial. [2023]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Implementing a patient decision aid, a process evaluation of a large-scale pre- and post-implementation trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Web-based decision aids for cancer clinical decisions: a systematic review and meta-analysis. [2021]

7. Netherlands 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Capturing treatment decision making among patients with solid tumors and their caregivers. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Building Family Caregiver Skills Using a Simulation-Based Intervention: A Randomized Pilot Trial. [2020]

11. Ireland pubmed.ncbi.nlm.nih.gov

The TRIO Framework: Conceptual insights into family caregiver involvement and influence throughout cancer treatment decision-making. [2022]