Palliative Care Intervention for Advanced Cancer

Overseen By Sarah Genung, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Disqualifiers: High suicide risk, Psychiatric hospitalization, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

Adults diagnosed with metastatic cancer commonly experience depression and anxiety symptoms, which can interfere with advance care planning. This randomized clinical trial evaluates a novel, piloted, primary palliative care intervention that addresses advance care planning and psychosocial needs of patients with metastatic cancer. The intervention focuses on patients with elevated anxiety and depression (anx/dep) symptoms-those with highest psychosocial needs who may be at greatest risk for advance care planning non-completion. The intervention is founded on an evidence-based intervention approach known as Acceptance and Commitment Therapy (ACT) that reduces distress and promotes behavior change through theory-driven mechanisms. In the proposed randomized trial, M-ACT will be compared to a usual care control condition. The study will also assess the association between advance care planning and anx/dep symptoms, thereby informing the critical practice question of whether anx/dep symptoms should be addressed concurrently with advance care planning. The study will enroll patients with Stage IV solid tumor cancer (N=240) within Rocky Mountain Cancer Centers, randomized 1:1 to M-ACT or usual care. The study aims to: 1) Evaluate the hypothesis that M-ACT will increase advance care planning completion (primary outcome) and sense of life meaning, and reduce anx/dep symptoms and fear of dying relative to usual care control. 2) Assess the association between anx/dep symptoms and advance care planning at baseline and over time, testing the hypothesis that decreases in anx/dep symptoms at post- intervention will be associated with increases in advance care planning at follow-up. 3) Assess M-ACT's hypothesized mechanisms to specify how the intervention works (exploratory aim). Given their advance care planning and psychosocial needs, and poor access to palliative care, rigorously investigating M-ACT has the potential to benefit community patients with metastatic cancer and to advance palliative care science by addressing gaps in novel approaches, foundational knowledge, and the scalable delivery of palliative care. Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the idea that Palliative Care Intervention for Advanced Cancer is an effective treatment?

The available research shows that Palliative Care Intervention for Advanced Cancer is effective in improving the quality of life for patients. It helps manage symptoms like pain and depression, and supports patients in making important decisions about their care. Studies have found that integrating palliative care with cancer treatment can lead to better symptom management and improved communication between patients and healthcare providers. This approach also helps in planning for end-of-life care, ensuring that patients' wishes are respected. ^{1 2 3 4 5}

What safety data exists for palliative care interventions in advanced cancer?

The available research indicates that palliative care interventions, including psychosocial and supportive care, have been evaluated in various clinical settings. Clinical trials, such as those conducted by the Victorian Comprehensive Cancer Centre, have shown that these interventions are feasible and acceptable, with increased attention to evidence-based care. However, specific safety data is not detailed in the provided studies, suggesting a need for more focused research on safety outcomes. ^{3 6 7 8 9}

Is the Multi-Modal Palliative Care Intervention a promising treatment for advanced cancer?

Yes, the Multi-Modal Palliative Care Intervention is promising because it helps improve the quality of life for patients with advanced cancer by addressing physical and emotional suffering. It involves a team approach to care, which has been shown to improve symptoms, end-of-life care quality, and satisfaction for both patients and healthcare providers. ^{3 8 10 11 12}

Research Team

Joanna Arch, PhD

Principal Investigator

University of Colorado, Boulder

Eligibility Criteria

This trial is for adults with Stage IV metastatic cancer who can understand and consent to the study, participate in group sessions online, and have moderate to severe anxiety or depression. They must be able to communicate in English and not be at high risk of suicide or have a recent history of psychiatric hospitalization.

Inclusion Criteria

English-speaking (able to speak, read, and write well in English)

I have been diagnosed with Stage IV cancer.

I understand the study, can attend sessions, and complete online tasks.

Exclusion Criteria

Current high suicide risk

I have not been hospitalized for psychiatric reasons or attempted suicide in the last 5 years.

History of chronic, untreated trauma unrelated to their cancer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the M-ACT intervention, consisting of five 2-hour group sessions and self-paced online modules over a 4-week period

4 weeks

5 group sessions (online), self-paced online modules

Booster Session

Participants attend a booster session to reinforce the intervention content

1 session, 1 month after treatment

1 session (online)

Follow-up

Participants are monitored for changes in advance care planning and psychosocial outcomes

2 months

Assessments at 1-week post-intervention and 2-month follow-up

Treatment Details

Interventions

• Multi-Modal Palliative Care Intervention
• Usual Care Control Condition

Trial Overview The trial tests a palliative care approach called M-ACT against usual care. M-ACT uses Acceptance and Commitment Therapy (ACT) to help patients manage distress, find life meaning, complete advance care planning, reduce fear of dying, and address symptoms of anxiety/depression.

Participant Groups

Group I: Multi-Modal Acceptance and Commitment Therapy (M-ACT) Experimental Treatment 1 Intervention

M-ACT consists of five 2-hour group sessions (plus booster) that alternate with self-paced online modules and check-ins that participants complete on their own, between the group sessions. The intervention addresses distress associated with coping with metastatic cancer and supports engagement in advance care planning. The intervention is based on Acceptance and Commitment Therapy, an intervention model that aims to help people cope with life challenges and difficult thoughts/feelings in a manner that helps them to live fuller and more meaningful lives.

Group II: Control: Usual Care Experimental Treatment 1 Intervention

Patients in the control arm will have access to usual care (UC) at the collaborating clinics, consisting of access to a clinical social worker and nurse practitioners for advance care planning and supportive visits at patient request. After completion of study procedures, including FU, the UC participants will be offered M-ACT free of cost.

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Rocky Mountain Cancer Centers

Collaborator

Trials

8

Recruited

1,500+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

Integrating oncology and palliative care can significantly enhance cancer patients' quality of life through improved symptom management and comprehensive support, as highlighted by various conceptual models that outline the rationale and benefits of integration.

The review discusses four major models of integration—time-based, provider-based, issue-based, and system-based—each offering insights into the feasibility and effectiveness of combining these care approaches, indicating that further research is necessary to establish best practices across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of integration of oncology and palliative care. Hui, D., Bruera, E.[2022]

The systematic review identified 40 operationalized and 19 non-operationalized quality measures for palliative care in cancer patients, with the most measures available for pain (12) and advance care planning (21), but very few for depression (4) and dyspnea (2).

Despite the availability of numerous measures, there is a critical need for testing these measures specifically in cancer populations, especially for pediatric cancer care, to ensure they effectively address the quality of supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer care quality measures: symptoms and end-of-life care. Lorenz, K., Lynn, J., Dy, S., et al.[2016]

The palliative care intervention in the ICU led to a 63% increase in the likelihood of family meetings and a 41% reduction in the time to these meetings, improving communication for families of high-risk patients.

Patients receiving the palliative care intervention had a 26% shorter overall hospital length of stay, indicating potential efficiency benefits, although there were no significant differences in family satisfaction or psychological symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of a proactive palliative care rounding intervention in a medical ICU. Braus, N., Campbell, TC., Kwekkeboom, KL., et al.[2018]

The study identified 36 quality measures related to palliative cancer care, focusing on pain, dyspnea, depression, and advance care planning (ACP), highlighting a significant emphasis on ACP measures.

Most of the identified measures were unpublished and lacked testing in cancer populations, indicating a need for further research and validation to ensure their effectiveness in improving symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality measures for symptoms and advance care planning in cancer: a systematic review. Lorenz, KA., Lynn, J., Dy, S., et al.[2023]

The review identified 12 outcome measures suitable for assessing palliative care in patients with advanced cancer, focusing on multiple domains such as physical, psychological, and spiritual well-being.

While these measures provide valuable insights for clinical audits and research, they vary in their validity, reliability, and responsiveness, indicating that careful selection is crucial for effective palliative care evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures in palliative care for advanced cancer patients: a review. Hearn, J., Higginson, IJ.[2019]

This scoping review identified 10 non-pharmacological interventions, such as music therapy and massage therapy, that are implemented to provide comfort in palliative care settings, primarily for cancer patients.

The review highlights the need for future research to explore these interventions in non-cancer patients and those receiving home care, as well as to conduct systematic reviews specifically on the effectiveness of music and massage therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of non-pharmacological interventions for comforting patients in palliative care: a scoping review. Coelho, A., Parola, V., Cardoso, D., et al.[2019]

The 'Building Capability in Palliative Care Clinical Trials' program successfully established multiple clinical trials across five palliative care services, recruiting 150 patients and conducting several Phase 2, 3, and 4 studies over two years.

The program enhanced the focus on evidence-based care among clinicians and increased research activity in palliative care, although ensuring long-term sustainability remains a challenge, especially due to the impacts of the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care Clinical Trials: Building Capability and Capacity. Philip, J., Le, B., Pasanen, L., et al.[2022]

The study outlines the use of the 'Promoting Resilience in Stress Management' (PRISM) intervention as a model for developing and adapting psychosocial care interventions in palliative care, emphasizing the importance of evidence-based theories and stakeholder involvement throughout the process.

Key lessons from the intervention development include the necessity of flexible delivery strategies tailored to patient needs and the value of interdisciplinary collaboration to enhance the effectiveness and dissemination of palliative care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Theory to Patient Care: A Model for the Development, Adaptation, and Testing of Psychosocial Interventions for Patients With Serious Illness. Rosenberg, AR., Steiner, J., Lau, N., et al.[2022]

The ENABLE II intervention involved a phone-based, nurse-led palliative care model for 279 participants, demonstrating that it is feasible to conduct rigorous randomized controlled trials in palliative care despite common methodological challenges.

The study highlights successful strategies to address issues like recruitment difficulties, missing data, and contamination in control groups, which can enhance the reliability of palliative care research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Bakitas, M., Lyons, KD., Hegel, MT., et al.[2023]

Patients with advanced nonmalignant lung disease often experience significant symptoms such as depression, anxiety, dyspnea, pain, and coughing, highlighting the need for effective palliative care.

Initiating early discussions about supportive care alongside life-prolonging treatments can improve quality of life and symptom management, while ongoing education for healthcare professionals is essential for providing adequate palliative support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive and palliative care of advanced nonmalignant lung disease. Kreuter, M., Herth, FJ.[2011]

The review identified 14 studies that highlight the effectiveness of multidisciplinary palliative care teams in improving symptom control, reducing caregiver burden, and enhancing continuity of care for patients with advanced cancer and chronic diseases in Europe.

A proposed generic framework for integrated palliative care emphasizes the importance of incorporating palliative care throughout the disease trajectory, focusing on treatment, consulting, and training to optimize patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated palliative care in Europe: a qualitative systematic literature review of empirically-tested models in cancer and chronic disease. Siouta, N., Van Beek, K., van der Eerden, ME., et al.[2023]

Integrating palliative care into cancer treatment significantly improves patient outcomes, including symptom relief, quality of end-of-life care, and overall satisfaction for both patients and providers.

Despite the clear benefits and existing guidelines for palliative care in oncology, barriers such as educational gaps and cultural misconceptions about palliative care being solely for end-of-life situations hinder its effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care always. Ramchandran, K., Von Roenn, JH.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

Models of integration of oncology and palliative care. [2022]

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

Cancer care quality measures: symptoms and end-of-life care. [2016]

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

Prospective study of a proactive palliative care rounding intervention in a medical ICU. [2018]

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

Quality measures for symptoms and advance care planning in cancer: a systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Outcome measures in palliative care for advanced cancer patients: a review. [2019]

6. Australia pubmed.ncbi.nlm.nih.gov

Use of non-pharmacological interventions for comforting patients in palliative care: a scoping review. [2019]

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

Palliative Care Clinical Trials: Building Capability and Capacity. [2022]

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

From Theory to Patient Care: A Model for the Development, Adaptation, and Testing of Psychosocial Interventions for Patients With Serious Illness. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive and palliative care of advanced nonmalignant lung disease. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Integrated palliative care in Europe: a qualitative systematic literature review of empirically-tested models in cancer and chronic disease. [2023]

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

Palliative care always. [2022]