Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04515810

Mobile Health Application (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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Locally Advanced Malignant Solid Neoplasm Death Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Metastatic Malignant Solid Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrent Hematologic Malignancy Refractory Hematologic Malignancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health, Manhasset, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Internet-Based Intervention

Other

Use smartphone application

Best Practice

Other

Engage in standard care

Other names: standard of care, standard therapy

telephone-based intervention

Other

Receive check-in call

Questionnaire Administration

Other

Ancillary studies

Post-intervention qualitative feedback interview

Other

Post-intervention qualitative feedback interview (with a subset of patients and support persons)

Primary outcomes

  1. 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

  2. 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

  3. Feasibility: Rates of intervention completion [Patients]

    Time frame: At 3 months post-randomization

    Will assess the percentage of enrolled patients who complete the intervention

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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.

  24. 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.

Secondary outcomes

  1. Change in treatment preference

    Time frame: Baseline to 3 months

    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).

  2. Change in treatment preference

    Time frame: Baseline to 6 months

    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).

  3. Change in healthcare utilization (summary score for total number of healthcare services utilized)

    Time frame: Baseline to 3 months

    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.

  4. Change in healthcare utilization (summary score for total number of healthcare services utilized)

    Time frame: Baseline to 6 months

    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.

  5. Change in number of subjects receiving goal-concordant care

    Time frame: Baseline to 3 months

    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.

  6. Change in number of subjects receiving goal-concordant care

    Time frame: Baseline to 6 months

    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.

  7. Change in perceived social support

    Time frame: Baseline to 3 months

    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).

  8. Change in perceived social support

    Time frame: Baseline to 6 months

    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).

  9. Change in family functioning

    Time frame: Baseline to 3 months

    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.

  10. Change in family functioning

    Time frame: Baseline to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia De Los Santos, B.S.

CONTACT

[email protected]

206-667-1565

Megan Shen, PhD

CONTACT

[email protected]

206-667-4172

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.