Locally Advanced Malignant Solid NeoplasmNCT04515810
Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
A study testing Internet-Based Intervention, Best Practice and Telephone-Based Intervention in people with Locally Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites in United States.
Trial summary
This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy
- What is being tested?
- Internet-Based Intervention, Best Practice and Telephone-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic solid cancer and/or disease progression following at least first line systemic therapy and/or relapsed or refractory hematologic cancer.
- PATIENT: Have internet access through a computer or a mobile device; the principal investigator (PI) will ensure that those who have access to a computer or mobile device have access to a computer or mobile device with internet access to ensure they can complete study procedures.
- PATIENT: The ability to provide informed consent.
- PATIENT: Identification of a loved support person if one is available; patients who are unable to identify a support person willing to participate with them will be allowed to continue in the study on their own.
- PATIENT: 18 years of age or older.
- SUPPORT PERSON: The person (family member or friend) whom the patient indicates being a support person.
Show all 11Show fewer
- SUPPORT PERSON: English speaking.
- SUPPORT PERSON: 18 years of age or older and able to provide informed consent.
- PROVIDER: Current clinical practice and/or research with advanced cancer patients.
- PROVIDER: A history of 3+ years working with advanced cancer patients.
- PROVIDER: 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled.
Who cannot join
- PATIENT: Not fluent in English.
- PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6) to be delivered by trained study research staff during screening.
- PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
- PATIENT: Currently receiving hospice at the time of enrollment.
- PATIENT: Children and young adults under age 18.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Not yet recruiting
Northwell Health
Manhasset, New York, 11030
Daniel McFarland, 212-434-4552, dmcfarland@northwell.edu
Daniel McFarland
- Active, not recruiting
Mount Sinai Hospital
New York, New York, 10029
- Not yet recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Holly Prigerson, 646-962-9655, hgp2001@med.cornell.edu
Holly Prigerson
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Claudia De Los Santos, B.S., 206-667-1565, cdelossa@fredhutch.org
Megan J Shen, PhD, 206-667-4172, mshen2@fredhutch.org
About this study
Official title: Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.
Read the detailed description
OUTLINE: Patients and support persons are randomized to 1 of 2 arms.
ARM I: Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study.
ARM II: Participants engage in standard care with no modifications for up to 4 weeks.
After completion of study intervention, participants are followed up at 3 and 6 months.
- Conditions
- Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy, Refractory Hematologic Malignancy
- Being tested
- Internet-Based Intervention, Best Practice, Telephone-Based Intervention, Questionnaire Administration, Post-intervention qualitative feedback interview
- Keywords
- Advance Care Planning, Advance Directives, End-of-Life, Cancer
- Medical subject headings
- Neoplasm Metastasis, Hematologic Neoplasms, Death, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Use smartphone application
Best PracticeOther
Also called standard of care, standard therapy
Engage in standard care
Telephone-Based InterventionOther
Receive check-in call
Questionnaire AdministrationOther
Ancillary studies
Post-intervention qualitative feedback interviewOther
Post-intervention qualitative feedback interview (with a subset of patients and support persons)
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PACT) | Experimental | Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study. Receives: Other: Internet-Based Intervention; Other: Telephone-Based Intervention; Other: Questionnaire Administration; Other: Post-intervention qualitative feedback interview |
| Arm II (standard care) | Active comparator | Participants engage in standard care with no modifications for up to 4 weeks. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Accrual rates [Patients]
Will assess the percentage of eligible approached patients who consent to enroll in the study
Measured: At 3 months post-randomization
Feasibility: Accrual rates [Support persons]
Will assess the percentage of eligible approached support persons who consent to enroll in the study
Measured: At 3 months post-randomization
Feasibility: Rates of intervention completion [Patients]
Will assess the percentage of enrolled patients who complete the intervention
Measured: At 3 months post-randomization
Feasibility: Rates of intervention completion [Support persons]
Will assess the percentage of enrolled support persons who complete the intervention
Measured: At 3 months post-randomization
Acceptability of the PACT application: Acceptability E-Scale [Patients]
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Measured: At 3 months post-randomization
Acceptability of the PACT application: Acceptability E-Scale [Support persons]
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Measured: At 3 months post-randomization
Usability of the PACT application: System Usability Scale (SUS) [Patients]
Usability of the PACT application will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Measured: At 3 months post-randomization
Usability of the PACT application: System Usability Scale (SUS) [Support persons]
Usability of the PACT application will be assessed among support persons using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Measured: At 3 months post-randomization
User satisfaction [Patients]
User satisfaction: Patients will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
Measured: At 3 months post-randomization
User satisfaction [Support persons]
User satisfaction: Support persons will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
Measured: At 3 months post-randomization
User engagement as measured by number of views [Patients]
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
Measured: Baseline to 3 months post-intervention
User engagement as measured by number of views [Support persons]
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
Measured: Baseline to 3 months post-intervention
User engagement as measured by time spent on app [Patients]
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Measured: Baseline to 3 months post-intervention
User engagement as measured by time spent on app [Support persons]
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Measured: Baseline to 3 months post-intervention
Change in level of engagement in advance care planning [Patients]
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Measured: Baseline to 3 months post-intervention
Change in level of engagement in advance care planning [Patients]
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Measured: Baseline to 6 months post-intervention
Change in level of engagement in advance care planning [Support persons]
Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Measured: Baseline to 3 months post-intervention
Change in level of engagement in advance care planning [Support persons]
Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Measured: Baseline to 6 months post-intervention
Change in documentation of advance care planning conversations [Patients]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Measured: Baseline to 3 months post-intervention
Change in documentation of advance care planning conversations [Patients]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Measured: Baseline to 6 months post-intervention
Change in documentation of advance care planning conversations [Support persons]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Measured: Baseline to 3 months post-intervention
Change in documentation of advance care planning conversations [Support persons]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Measured: Baseline to 6 months post-intervention
Change in completion of advance directives
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Measured: Baseline to 3 months post-intervention
Change in completion of advance directives
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Measured: Baseline to 6 months post-intervention
Secondary outcomes (10)
Change in treatment preference
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Measured: Baseline to 3 months
Change in treatment preference
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Measured: Baseline to 6 months
Change in healthcare utilization (summary score for total number of healthcare services utilized)
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Measured: Baseline to 3 months
Change in healthcare utilization (summary score for total number of healthcare services utilized)
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Measured: Baseline to 6 months
Change in number of subjects receiving goal-concordant care
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Measured: Baseline to 3 months
Change in number of subjects receiving goal-concordant care
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Measured: Baseline to 6 months
Change in perceived social support
This will be assessed among patients and support persons using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Measured: Baseline to 3 months
Change in perceived social support
This will be assessed among patients and support persons using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Measured: Baseline to 6 months
Change in family functioning
This will be assessed among patients and support persons using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Measured: Baseline to 3 months
Change in family functioning
This will be assessed among patients and support persons using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start18 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Megan J Shen, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515810
- Sponsor's protocol ID
- RG1121852
- Other IDs
- R37CA246703, NCI-2022-00398, 10849
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2020
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karnofsky DA. Determining the extent of the cancer and clinical planning for cure. Cancer. 1968 Oct;22(4):730-4. doi: 10.1002/1097-0142(196810)22:43.0.co;2-h.
PubMed 5212297Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
PubMed 20974066S. Summers and A. Watt,
Borsci S, Federici S, Lauriola M. On the dimensionality of the System Usability Scale: a test of alternative measurement models. Cogn Process. 2009 Aug;10(3):193-7. doi: 10.1007/s10339-009-0268-9. Epub 2009 Jun 30.
PubMed 19565283Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013 Sep 5;8(9):e72465. doi: 10.1371/journal.pone.0072465. eCollection 2013.
PubMed 24039772Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.
PubMed 20124172Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
PubMed 2280326Kissane DW, McKenzie M, McKenzie DP, Forbes A, O'Neill I, Bloch S. Psychosocial morbidity associated with patterns of family functioning in palliative care: baseline data from the Family Focused Grief Therapy controlled trial. Palliat Med. 2003 Sep;17(6):527-37. doi: 10.1191/0269216303pm808oa.
PubMed 14526887Edwards B, Clarke V. The validity of the family relationships index as a screening tool for psychological risk in families of cancer patients. Psychooncology. 2005 Jul;14(7):546-54. doi: 10.1002/pon.876.
PubMed 15546124Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014 Sep;28(8):1000-25. doi: 10.1177/0269216314526272. Epub 2014 Mar 20.
PubMed 24651708Garrido MM, Balboni TA, Maciejewski PK, Bao Y, Prigerson HG. Quality of Life and Cost of Care at the End of Life: The Role of Advance Directives. J Pain Symptom Manage. 2015 May;49(5):828-35. doi: 10.1016/j.jpainsymman.2014.09.015. Epub 2014 Dec 11.
PubMed 25498855Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
PubMed 20332506Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.
PubMed 18840840Garrido MM, Harrington ST, Prigerson HG. End-of-life treatment preferences: a key to reducing ethnic/racial disparities in advance care planning? Cancer. 2014 Dec 15;120(24):3981-6. doi: 10.1002/cncr.28970. Epub 2014 Aug 21.
PubMed 25145489Dow LA, Matsuyama RK, Ramakrishnan V, Kuhn L, Lamont EB, Lyckholm L, Smith TJ. Paradoxes in advance care planning: the complex relationship of oncology patients, their physicians, and advance medical directives. J Clin Oncol. 2010 Jan 10;28(2):299-304. doi: 10.1200/JCO.2009.24.6397. Epub 2009 Nov 23.
PubMed 19933909
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
- ClinicalTrials.gov ID
- NCT04515810
- Acronym / sponsor ID
- RG1121852
- Conditions
- Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy, Refractory Hematologic Malignancy
- Keywords
- Advance Care Planning, Advance Directives, End-of-Life, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Aug 2020 (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.
This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.
Detailed description
OUTLINE: Patients and support persons are randomized to 1 of 2 arms.
ARM I: Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study.
ARM II: Participants engage in standard care with no modifications for up to 4 weeks.
After completion of study intervention, participants are followed up at 3 and 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PACT) | Experimental | Other: Internet-Based Intervention, Other: Telephone-Based Intervention, Other: Questionnaire Administration, Other: Post-intervention qualitative feedback interviewParticipants use PACT mHealth app for up to 4 weeks and receive one check-in call on study. |
| Arm II (standard care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationParticipants engage in standard care with no modifications for up to 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic solid cancer and/or disease progression following at least first line systemic therapy and/or relapsed or refractory hematologic cancer.
- PATIENT: Have internet access through a computer or a mobile device; the principal investigator (PI) will ensure that those who have access to a computer or mobile device have access to a computer or mobile device with internet access to ensure they can complete study procedures.
- PATIENT: The ability to provide informed consent.
- PATIENT: Identification of a loved support person if one is available; patients who are unable to identify a support person willing to participate with them will be allowed to continue in the study on their own.
- PATIENT: 18 years of age or older.
Key exclusion criteria (5 listed)
- PATIENT: Not fluent in English.
- PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6) to be delivered by trained study research staff during screening.
- PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
- PATIENT: Currently receiving hospice at the time of enrollment.
- PATIENT: Children and young adults under age 18.
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 |
|---|---|---|
| Internet-Based InterventionUse smartphone application | Other | Arm I (PACT) |
| Best PracticeAlso: standard of care, standard therapyEngage in standard care | Other | Arm II (standard care) |
| Telephone-Based InterventionReceive check-in call | Other | Arm I (PACT) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (PACT), Arm II (standard care) |
| Post-intervention qualitative feedback interviewPost-intervention qualitative feedback interview (with a subset of patients and support persons) | Other | Arm I (PACT) |
Primary outcome
Feasibility: Accrual rates [Patients]
Time frame: At 3 months post-randomization
Will assess the percentage of eligible approached patients who consent to enroll in the study
Feasibility: Accrual rates [Support persons]
Time frame: At 3 months post-randomization
Will assess the percentage of eligible approached support persons who consent to enroll in the study
Feasibility: Rates of intervention completion [Patients]
Time frame: At 3 months post-randomization
Will assess the percentage of enrolled patients who complete the intervention
Feasibility: Rates of intervention completion [Support persons]
Time frame: At 3 months post-randomization
Will assess the percentage of enrolled support persons who complete the intervention
Acceptability of the PACT application: Acceptability E-Scale [Patients]
Time frame: At 3 months post-randomization
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Acceptability of the PACT application: Acceptability E-Scale [Support persons]
Time frame: At 3 months post-randomization
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Usability of the PACT application: System Usability Scale (SUS) [Patients]
Time frame: At 3 months post-randomization
Usability of the PACT application will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Usability of the PACT application: System Usability Scale (SUS) [Support persons]
Time frame: At 3 months post-randomization
Usability of the PACT application will be assessed among support persons using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
User satisfaction [Patients]
Time frame: At 3 months post-randomization
User satisfaction: Patients will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
User satisfaction [Support persons]
Time frame: At 3 months post-randomization
User satisfaction: Support persons will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
User engagement as measured by number of views [Patients]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by number of views [Support persons]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by time spent on app [Patients]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
User engagement as measured by time spent on app [Support persons]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Change in level of engagement in advance care planning [Patients]
Time frame: Baseline to 3 months post-intervention
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Patients]
Time frame: Baseline to 6 months post-intervention
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Support persons]
Time frame: Baseline to 3 months post-intervention
Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Support persons]
Time frame: Baseline to 6 months post-intervention
Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in documentation of advance care planning conversations [Patients]
Time frame: Baseline to 3 months post-intervention
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Change in documentation of advance care planning conversations [Patients]
Time frame: Baseline to 6 months post-intervention
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Change in documentation of advance care planning conversations [Support persons]
Time frame: Baseline to 3 months post-intervention
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Change in documentation of advance care planning conversations [Support persons]
Time frame: Baseline to 6 months post-intervention
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Change in completion of advance directives
Time frame: Baseline to 3 months post-intervention
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Change in completion of advance directives
Time frame: Baseline to 6 months post-intervention
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
10 secondary outcomes
Change in treatment preference
Time frame: Baseline to 3 months
Change in treatment preference
Time frame: Baseline to 6 months
Change in healthcare utilization (summary score for total number of healthcare services utilized)
Time frame: Baseline to 3 months
Change in healthcare utilization (summary score for total number of healthcare services utilized)
Time frame: Baseline to 6 months
Change in number of subjects receiving goal-concordant care
Time frame: Baseline to 3 months
Change in number of subjects receiving goal-concordant care
Time frame: Baseline to 6 months
Change in perceived social support
Time frame: Baseline to 3 months
Change in perceived social support
Time frame: Baseline to 6 months
Change in family functioning
Time frame: Baseline to 3 months
Change in family functioning
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 5212297Karnofsky DA. Determining the extent of the cancer and clinical planning for cure. Cancer. 1968 Oct;22(4):730-4. doi: 10.1002/1097-0142(196810)22:43.0.co;2-h.
- Background: PubMed 20974066Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
- BackgroundS. Summers and A. Watt,
- Background: PubMed 19565283Borsci S, Federici S, Lauriola M. On the dimensionality of the System Usability Scale: a test of alternative measurement models. Cogn Process. 2009 Aug;10(3):193-7. doi: 10.1007/s10339-009-0268-9. Epub 2009 Jun 30.
- Background: PubMed 24039772Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013 Sep 5;8(9):e72465. doi: 10.1371/journal.pone.0072465. eCollection 2013.
- Background: PubMed 20124172Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.
- Background: PubMed 2280326Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
- Background: PubMed 14526887Kissane DW, McKenzie M, McKenzie DP, Forbes A, O'Neill I, Bloch S. Psychosocial morbidity associated with patterns of family functioning in palliative care: baseline data from the Family Focused Grief Therapy controlled trial. Palliat Med. 2003 Sep;17(6):527-37. doi: 10.1191/0269216303pm808oa.
- Background: PubMed 15546124Edwards B, Clarke V. The validity of the family relationships index as a screening tool for psychological risk in families of cancer patients. Psychooncology. 2005 Jul;14(7):546-54. doi: 10.1002/pon.876.
- Background: PubMed 24651708Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014 Sep;28(8):1000-25. doi: 10.1177/0269216314526272. Epub 2014 Mar 20.
- Background: PubMed 25498855Garrido MM, Balboni TA, Maciejewski PK, Bao Y, Prigerson HG. Quality of Life and Cost of Care at the End of Life: The Role of Advance Directives. J Pain Symptom Manage. 2015 May;49(5):828-35. doi: 10.1016/j.jpainsymman.2014.09.015. Epub 2014 Dec 11.
- Background: PubMed 20332506Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
- Usability.gov. System Usability Scale (SUS)Link provided by the sponsor.
- Measuring Usability with the System Usability ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Megan J Shen, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Best Practice and Telephone-Based Intervention in people with Locally Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia De Los Santos, B.S. (206-667-1565, cdelossa@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Accrual rates [Patients] (time frame: At 3 months post-randomization). The study lists 24 primary outcomes in all. 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 NCT04515810, which also lists 32 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 17 Aug 2026.