An interventional study of Internet-Based Intervention and Best Practice in Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm and Recurrent Hematologic Malignancy, sponsored by Fred Hutchinson Cancer Center. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Health services research
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.
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study.
Other: Internet-Based Intervention · Other: Telephone-Based Intervention · Other: Questionnaire Administration · Other: Post-intervention qualitative feedback interview
Participants engage in standard care with no modifications for up to 4 weeks.
Other: Best Practice · Other: Questionnaire Administration
Use smartphone application
Engage in standard care
Also known as: standard of care, standard therapy
Receive check-in call
Ancillary studies
Post-intervention qualitative feedback interview (with a subset of patients and support persons)
Feasibility: Accrual rates [Patients]
Will assess the percentage of eligible approached patients who consent to enroll in the study
Time frame: 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
Time frame: At 3 months post-randomization
Feasibility: Rates of intervention completion [Patients]
Will assess the percentage of enrolled patients who complete the intervention
Time frame: At 3 months post-randomization
Feasibility: Rates of intervention completion [Support persons]
Will assess the percentage of enrolled support persons who complete the intervention
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months post-intervention
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Not enrolling at this site.
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for May 2027, 27 months after the start.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's planned 27 months is below that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
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