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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new palliative care approach for people with advanced cancer, who often face anxiety and depression, complicating future care planning. The study tests Acceptance and Commitment Therapy (ACT), which helps patients manage difficult emotions and plan their care. Participants will either attend group therapy sessions and complete online modules as part of the Multi-Modal Palliative Care Intervention or receive regular care, including support from social workers and nurse practitioners. This trial suits those with Stage IV solid tumor cancer who experience significant anxiety or depression. As an unphased trial, it offers patients the chance to contribute to innovative care strategies that could enhance emotional well-being and future care planning.

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 prior data suggests that this palliative care intervention is safe for patients with metastatic cancer?

Research has shown that Acceptance and Commitment Therapy (ACT), the foundation of this trial's palliative care approach, is generally easy for people to handle. Participants in similar ACT programs have reported very few negative effects. These programs help individuals manage stress and improve their quality of life by encouraging acceptance of difficult thoughts and feelings and promoting positive behavioral changes.

Although specific safety data for this exact intervention is not available, the use of ACT in other contexts suggests it is safe for participants. The program aims to support individuals by reducing anxiety and depression in those with advanced cancer. It focuses on mental well-being and is offered in a group setting and online at one's own pace, making it both accessible and gentle for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multi-Modal Acceptance and Commitment Therapy (M-ACT) because it offers a comprehensive approach to palliative care for individuals with advanced cancer. Unlike standard treatments that may focus primarily on medical symptom management, M-ACT is designed to address the emotional and psychological distress that comes with metastatic cancer through a combination of in-person group sessions and self-paced online modules. This therapy emphasizes acceptance and commitment strategies to help patients manage difficult thoughts and feelings, ultimately supporting them in living fuller, more meaningful lives. Additionally, the integration of advance care planning into the therapy helps patients make informed decisions about their future care, which is not always a focus in traditional palliative care settings.

What evidence suggests that this intervention could be effective for patients with metastatic cancer?

Research has shown that Acceptance and Commitment Therapy (ACT) can reduce distress and promote positive changes by addressing difficult thoughts and feelings. Studies have found that ACT improves the quality of life and mental health for individuals with advanced cancer. Specifically, patients in these studies experienced reduced anxiety and depression, common issues for those with metastatic cancer. This trial will test a Multi-Modal Acceptance and Commitment Therapy (M-ACT) intervention, designed to help participants cope with metastatic cancer and engage in advance care planning. Overall, ACT has effectively helped patients live fuller, more meaningful lives despite their illness. ^{1 2 4 5 6}

Who Is on the Research Team?

Joanna Arch, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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 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 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]

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]

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]

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