Depression, AnxietyNCT04773639
Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention
A study testing Multi-Modal Palliative Care Intervention in people with Depression, Anxiety and Metastatic Cancer, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Metastatic Cancer
- What is being tested?
- Multi-Modal Palliative Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- English-speaking (able to speak, read, and write well in English)
- Diagnosed with Stage IV metastatic cancer of any solid tumor type
- Capable at time of consent of understanding and voluntarily consenting themselves to the study, attending group sessions, and completing the online sessions at home, confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2
- Endorse moderate to severe anxiety or depression symptoms on the Patient Health Questionnaire-4
Who cannot join
- Current high suicide risk
- Psychiatric hospitalization or suicide attempt in the past 5 years
- History of chronic, untreated trauma unrelated to their cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303
About this study
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.
Read the detailed description
This study will evaluate an innovative, multi-modal palliative care intervention that addresses the lack of advance care planning (ACP) and unmet psychosocial needs commonly experienced by patients with metastatic cancer. Up to half of adults with metastatic cancer report elevated anxiety or depression symptoms, which can cause withdrawal from daily activities and future planning and have been linked to non-adherent health behaviors in other disease populations. However, little is known about the extent to which anxiety or depression influence ACP completion in palliative care. In addition, metastatic cancer triggers patients' fear of dying and threatens their sense of meaning. The current approach aims to optimize two core palliative care outcomes - ACP and psychosocial well being - in outpatient oncology settings and to build the evidence base for primary palliative care interventions. This new multimodal intervention, which is based on extensive pilot data, uses a primary palliative care approach and focuses on patients with elevated anxiety or depression (anx/dep) symptoms.
The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach to reduce distress and promote behavior change through theorized mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. A pilot study for adults with metastatic cancer and elevated anx/dep symptoms conducted by the current research team, leveraged ACT to design and refine the multi-modal ACT intervention (M-ACT) in response to patient and provider feedback. M-ACT helps metastatic cancer patients to live meaningfully and face the future no matter what their health status, supports their engagement in ACP and addresses their psychosocial needs.
To facilitate future scalability, M-ACT uses a novel multi-modal delivery structure comprising both in-person group sessions led by existing on-site clinical social workers and self-paced, personalized online sessions completed at home, which efficiently increase intervention dose without increasing patient travel or provider demands. The current randomized controlled trial will rigorously evaluate the ability of M-ACT to increase ACP (primary outcome) and improve psychosocial outcomes (secondary). This study also will evaluate the relationship between anx/dep symptoms and ACP to inform the critical clinical question of whether anx/dep symptoms should be addressed concurrently with ACP. Finally, the study will explore mechanisms that may explain how M-ACT influences ACP and the targeted secondary outcomes.
The study will enroll patients with stage IV solid tumor cancer (N = 240), randomized in a 1:1 ratio to M-ACT or usual care for a 4-week intervention period. Outcomes will be assessed at baseline, mid-intervention (to assess mechanisms), 1-week post-intervention, and 2-month follow-up.
Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.
- Conditions
- Depression, Anxiety, Metastatic Cancer
- Being tested
- Multi-Modal Palliative Care Intervention, Usual Care Control Condition
- Medical subject headings
- Depression, Anxiety Disorders, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Modal Palliative Care InterventionBehavioural
An innovative muli-modal palliative care intervention that addresses the lack of advance care planning and unmet psychosocial needs commonly experienced by patients with metastatic cancer.
Usual Care Control ConditionBehavioural
The control condition includes 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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Modal Acceptance and Commitment Therapy (M-ACT) | Experimental | 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. Receives: Behavioral: Multi-Modal Palliative Care Intervention |
| Control: Usual Care | Other | 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. Receives: Behavioral: Usual Care Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in advance care planning
The primary outcome is defined as change in the number of steps taken toward ACP completion from baseline through 2-month follow-up. ACP steps will be assessed with a checklist adapted from the M-ACT pilot study by consulting the Hospice \& Palliative Nurses Association online ACP resources and the study team, and refined by soliciting pilot participants' feedback on item clarity. The checklist describes each ACP step and asks patients to indicate steps taken to date.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-9)
Patient-reported depression symptom questionnaire. Higher scores = more depression symptoms
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Generalized Anxiety Disorder-7
Patient-reported anxiety symptom questionnaire. Higher scores = more anxiety symptoms
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
The Death Attitude Profile - Revised, Fear of Death and Death Avoidance Scales
Patient-reported fear of death and dying questionnaire. Higher scores = greater fear of death and dying
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Functional Assessment of Chronic Illness Therapy (FACIT), Meaning/Peace Subscale
Patient-reported sense of life meaning and peace. Higher scores = greater sense of meaning/peace
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start11 Jan 2021
- Primary completion1 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a randomized controlled trial, this project evaluates the M-ACT intervention for community patients with metastatic cancer relative to the usual care control condition, reflecting Stage IIb/III of the NIH stage model for evaluating behavioral interventions. We will randomize 240 patients to M-ACT or usual care for five weeks (n per condition = 120) and assess them at Baseline (Pre), Mid-Intervention (Mid), Post-Intervention (Post), and 2-month Follow-Up (FU).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Rocky Mountain Cancer Centers, University of Colorado, Denver, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Joanna Arch, University of Colorado, Boulder
- Investigators
- Joanna J Arch, PHD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773639
- Sponsor's protocol ID
- 19-0787
- Other IDs
- R01NR018479
- Status last verified
- May 2025
- First submitted
- 10 Feb 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arch JJ, Fishbein JN, Ferris MC, Mitchell JL, Levin ME, Slivjak ET, Andorsky DJ, Kutner JS. Acceptability, Feasibility, and Efficacy Potential of a Multimodal Acceptance and Commitment Therapy Intervention to Address Psychosocial and Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic Cancer. J Palliat Med. 2020 Oct;23(10):1380-1385. doi: 10.1089/jpm.2019.0398. Epub 2020 Jan 6.
PubMed 31905307Arch JJ, Mitchell JL, Schmiege SJ, Levin ME, Nealis MS, Genung SR, Fink RM, Andorsky DJ, Kutner JS. Valued Living intervention to increase advance care planning and well-being in depressed and anxious adults with advanced cancer: Randomized trial in community oncology clinics. Cancer. 2026 Mar 15;132(6):e70349. doi: 10.1002/cncr.70349.
PubMed 41848105Arch JJ, Mitchell JL, Schmiege SJ, Levin ME, Genung SR, Nealis MS, Fink RM, Bright EE, Andorsky DJ, Kutner JS. A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol. BMC Palliat Care. 2022 Nov 17;21(1):198. doi: 10.1186/s12904-022-01087-z.
PubMed 36384735
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention
- ClinicalTrials.gov ID
- NCT04773639
- Acronym / sponsor ID
- 19-0787
- Conditions
- Depression, Anxiety, Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Rocky Mountain Cancer Centers, University of Colorado, Denver, National Institute of Nursing Research (NINR)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will evaluate an innovative, multi-modal palliative care intervention that addresses the lack of advance care planning (ACP) and unmet psychosocial needs commonly experienced by patients with metastatic cancer. Up to half of adults with metastatic cancer report elevated anxiety or depression symptoms, which can cause withdrawal from daily activities and future planning and have been linked to non-adherent health behaviors in other disease populations. However, little is known about the extent to which anxiety or depression influence ACP completion in palliative care. In addition, metastatic cancer triggers patients' fear of dying and threatens their sense of meaning. The current approach aims to optimize two core palliative care outcomes - ACP and psychosocial well being - in outpatient oncology settings and to build the evidence base for primary palliative care interventions. This new multimodal intervention, which is based on extensive pilot data, uses a primary palliative care approach and focuses on patients with elevated anxiety or depression (anx/dep) symptoms.
The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach to reduce distress and promote behavior change through theorized mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. A pilot study for adults with metastatic cancer and elevated anx/dep symptoms conducted by the current research team, leveraged ACT to design and refine the multi-modal ACT intervention (M-ACT) in response to patient and provider feedback. M-ACT helps metastatic cancer patients to live meaningfully and face the future no matter what their health status, supports their engagement in ACP and addresses their psychosocial needs.
To facilitate future scalability, M-ACT uses a novel multi-modal delivery structure comprising both in-person group sessions led by existing on-site clinical social workers and self-paced, personalized online sessions completed at home, which efficiently increase intervention dose without increasing patient travel or provider demands. The current randomized controlled trial will rigorously evaluate the ability of M-ACT to increase ACP (primary outcome) and improve psychosocial outcomes (secondary). This study also will evaluate the relationship between anx/dep symptoms and ACP to inform the critical clinical question of whether anx/dep symptoms should be addressed concurrently with ACP. Finally, the study will explore mechanisms that may explain how M-ACT influences ACP and the targeted secondary outcomes.
The study will enroll patients with stage IV solid tumor cancer (N = 240), randomized in a 1:1 ratio to M-ACT or usual care for a 4-week intervention period. Outcomes will be assessed at baseline, mid-intervention (to assess mechanisms), 1-week post-intervention, and 2-month follow-up.
Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a randomized controlled trial, this project evaluates the M-ACT intervention for community patients with metastatic cancer relative to the usual care control condition, reflecting Stage IIb/III of the NIH stage model for evaluating behavioral interventions. We will randomize 240 patients to M-ACT or usual care for five weeks (n per condition = 120) and assess them at Baseline (Pre), Mid-Intervention (Mid), Post-Intervention (Post), and 2-month Follow-Up (FU).
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal Acceptance and Commitment Therapy (M-ACT) | Experimental | Behavioral: Multi-Modal Palliative Care InterventionM-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. |
| Control: Usual Care | Other | Behavioral: Usual Care Control ConditionPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- English-speaking (able to speak, read, and write well in English)
- Diagnosed with Stage IV metastatic cancer of any solid tumor type
- Capable at time of consent of understanding and voluntarily consenting themselves to the study, attending group sessions, and completing the online sessions at home, confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2
- Endorse moderate to severe anxiety or depression symptoms on the Patient Health Questionnaire-4
Key exclusion criteria (3 listed)
- Current high suicide risk
- Psychiatric hospitalization or suicide attempt in the past 5 years
- History of chronic, untreated trauma unrelated to their cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Modal Palliative Care InterventionAn innovative muli-modal palliative care intervention that addresses the lack of advance care planning and unmet psychosocial needs commonly experienced by patients with metastatic cancer. | Behavioural | Multi-Modal Acceptance and Commitment Therapy (M-ACT) |
| Usual Care Control ConditionThe control condition includes 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. | Behavioural | Control: Usual Care |
Primary outcome
Change in advance care planning
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
The primary outcome is defined as change in the number of steps taken toward ACP completion from baseline through 2-month follow-up. ACP steps will be assessed with a checklist adapted from the M-ACT pilot study by consulting the Hospice \& Palliative Nurses Association online ACP resources and the study team, and refined by soliciting pilot participants' feedback on item clarity. The checklist describes each ACP step and asks patients to indicate steps taken to date.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Generalized Anxiety Disorder-7
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
The Death Attitude Profile - Revised, Fear of Death and Death Avoidance Scales
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Functional Assessment of Chronic Illness Therapy (FACIT), Meaning/Peace Subscale
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 31905307Arch JJ, Fishbein JN, Ferris MC, Mitchell JL, Levin ME, Slivjak ET, Andorsky DJ, Kutner JS. Acceptability, Feasibility, and Efficacy Potential of a Multimodal Acceptance and Commitment Therapy Intervention to Address Psychosocial and Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic Cancer. J Palliat Med. 2020 Oct;23(10):1380-1385. doi: 10.1089/jpm.2019.0398. Epub 2020 Jan 6.
- Derived from this study: PubMed 41848105Arch JJ, Mitchell JL, Schmiege SJ, Levin ME, Nealis MS, Genung SR, Fink RM, Andorsky DJ, Kutner JS. Valued Living intervention to increase advance care planning and well-being in depressed and anxious adults with advanced cancer: Randomized trial in community oncology clinics. Cancer. 2026 Mar 15;132(6):e70349. doi: 10.1002/cncr.70349.
- Derived from this study: PubMed 36384735Arch JJ, Mitchell JL, Schmiege SJ, Levin ME, Genung SR, Nealis MS, Fink RM, Bright EE, Andorsky DJ, Kutner JS. A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol. BMC Palliat Care. 2022 Nov 17;21(1):198. doi: 10.1186/s12904-022-01087-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna J Arch, PHD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Modal Palliative Care Intervention in people with Depression, Anxiety and Metastatic Cancer, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in advance care planning (time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773639, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.