Evaluation of Palliative Care for Patients With ALS and Their Caregivers

NCT04257760 | Completed

• 1 other identifier: ALSPall1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Amyotrophic lateral sclerosis (ALS) is a degenerative illness which currently has no medical cure. It is routinely accompanied by a significant symptom burden including high levels of distress in patients and their caregivers. As a result, an early palliative care approach is recommended in the ALS population. Palliative care has been shown to have positive effects on the quality of life in patients and caregivers in other life limiting illness such as cancer and multiple sclerosis. Unfortunately, our understanding of the palliative care needs in ALS is limited and the efficacy of palliative care involvement is poorly understood. Furthermore, ALS patients are largely underserved by palliative care in Ontario, with \<50% of ALS patients receiving palliative care even in the last year of life. Hypothesis: The investigators hypothesize that ALS patients will be agreeable to palliative care consultations and that this will improve the quality of life of patients and their caregivers. Specific Aims: This project seeks to initiate routine palliative care consultation in an interdisciplinary ALS clinic to: 1) improve patient and caregiver quality of life, 2) further understand the palliative care needs of the ALS population and 3) identify which patients and caregivers are most likely to benefit from palliative care consultation, thus guiding clinicians on when to refer in the future. Significance: This study is the first investigate the feasibility and efficacy of palliative care consultation in the ALS population, and its effects on quality of life. It has the potential to provide increased support to patients as well as caregivers. Finally, this study will aid in our understanding of the optimal time to involve palliative care in the ALS population and will act as a foundation on which larger, controlled studies can be built.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; palliative care; caregivers

Outcome Measures

Primary Outcomes (6)

• Change in average ALS Specific Quality of Life - Revised score in ALS patients post palliative care

  the change in the average score of ALS patients on the ALS Specific Quality of Life - Revised scale. On the scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  At baseline compared to 1 month and 3 months after palliative care consultation

• Difference in average ALS Specific Quality of Life - Revised score between arms

  The difference between the average ALS Specific Quality of Life - Revised score between ALS patients who received the palliative care consultation and patients who did not. On the ALS Specific Quality of Life - Revised scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  At baseline, 1 month and 3 months after palliative care consultation or study enrollment

• Difference in average Hospital Anxiety and Depression Scale score for ALS patients between arms

  The difference between the average Hospital Anxiety and Depression Scale score between ALS patients who received the palliative care consultation and patients who did not. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  At baseline, 1 month and 3 months after palliative care consultation or study enrollment

• Difference in average Hospital Anxiety and Depression Scale score for caregivers of ALS patients between arms

  The difference between the average Hospital Anxiety and Depression Scale score between caregivers of ALS patients who received the palliative care consultation and caregivers of patients who did not. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  At baseline, 1 month and 3 months after palliative care consultation or study enrollment

• Change in average Hospital Anxiety and Depression Scale score in patients with ALS

  the change in the average Hospital Anxiety and Depression Scale scores in ALS patients. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  At baseline compared to 1 month and 3 months post palliative care consultation

• Change in average Hospital Anxiety and Depression Scale score in caregivers of patients with ALS

  The change in the average Hospital Anxiety and Depression Scale scores for caregivers of ALS patients. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  At baseline compared to 1 month and 3 months post palliative care consultation

Secondary Outcomes (9)

• Patient satisfaction with palliative care consultation on the Satisfaction with Palliative Care Questionnaire

  at 24 months

• care provided through palliative care consultation

  at 24 months

• reasons for decision to pursue palliative care consultation or not

  at 24 months

• Change in average ALS Specific Quality of Life - Revised score in ALS patients post palliative care

  At baseline compared to 6 month, 12 months, 15 months, 18 months, 21 months after palliative care consult

• Change in average Hospital Anxiety and Depression Scale score in ALS patients post palliative care

  At baseline compared to 6 month, 12 months, 15 months, 18 months, 21 months after palliative care consult

Other Outcomes (1)

• Proportion of patients who complete a palliative care consultation

  at 24 months

Study Arms (2)

Standard care

NO INTERVENTION

These ALS patients and their caregivers will receive standard care.

Early palliative care

EXPERIMENTAL

These patients will receive a palliative care consultation that would not be requested by their care team as standard of care.

Behavioral: Palliative Care consultation outside standard of care

Interventions

Palliative Care consultation outside standard of care BEHAVIORAL

The ALS patients and their caregivers will receive a consultation with a palliative care physician. This will take approximately one hour and occur in their location of choice (ie. often the patient's home). Subsequent palliative care consultations will occur at the discretion of the ALS patient and the palliative care physician.

Early palliative care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with ALS at the Ottawa Hospital ALS clinic or caregiver of participating patient.

You may not qualify if:

• Significant cognitive impairment Prior palliative care consultation

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• ALS Society of Canada: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1S4X7, Canada

Location

Related Publications (2)

• Watt CL, Smith IC, Rice J, Murphy R, Breiner A, Duff MLV, Nogo D, Bush SH, McNeely S, Buenger U, Zehrt B, Zwicker J. Qualitative Analysis of Initial Palliative Care Consultations in Amyotrophic Lateral Sclerosis. J Pain Symptom Manage. 2024 Jul;68(1):43-52.e2. doi: 10.1016/j.jpainsymman.2024.03.024. Epub 2024 Apr 2.

  PMID: 38574876 DERIVED

• Zwicker J, Smith IC, Rice J, Murphy R, Breiner A, McNeely S, Duff M, Buenger U, Zehrt B, Nogo D, Watt CL. Palliative care at any stage of amyotrophic lateral sclerosis: a prospective feasibility study. Front Med (Lausanne). 2023 Sep 13;10:1204816. doi: 10.3389/fmed.2023.1204816. eCollection 2023.

  PMID: 37780560 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jocelyn C Zwicker, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Christine Watt, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The patients, the palliative care physicians and the research team will know if a palliative care consultation has been done or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a pilot trial to assess the feasibility of palliative care for ALS patients. Patients will be in the palliative care or non-palliative care arm of the trial based on their decision to have a palliative care consultation or not. If they do not initially chose a palliative care consult they can change their mind during the course of the trial.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 6, 2020
• Study Start: October 8, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)