Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Internet-Based Intervention; Other: Best Practice

Detailed Description

OUTLINE: Patients and support persons are randomized to 1 of 2 arms.

ARM I: Participants use PACT mHealth app.

ARM II: Participants engage in standard care with no modifications.

After completion of study intervention, participants are followed up at 3 and 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia De Los Santos, B.S.; Phone Number: 206-667-1565; Email: cdelossa@fredhutch.org
• Study Contact Backup: Name: Megan Shen, PhD; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
      • Contact: Daniel McFarland; Phone Number: 212-434-4552; Email: dmcfarland@northwell.edu
      • Principal Investigator: Daniel McFarland
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
      • Contact: Sarah Miller; Phone Number: 212-824-7783; Email: sarah.miller@mssm.edu
      • Principal Investigator: Sarah Miller
    • New York, New York, United States, 10065
      • NYP/Weill Cornell Medical Center
      • Contact: Holly Prigerson; Phone Number: 646-962-9655; Email: hgp2001@med.cornell.edu
      • Principal Investigator: Holly Prigerson
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Megan J Shen, PhD; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org
      • Principal Investigator: Megan J Shen, PhD
      • Contact: Claudia De Los Santos, B.S.; Phone Number: 206-667-1565; Email: cdelossa@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy.
• PATIENT: Access to a mobile device; the principal investigator (PI) will ensure that those who have access to a mobile device have access to a mobile device with internet access to ensure they can complete study procedures.
• PATIENT: The ability to provide informed consent.
• PATIENT: Identification and enrollment of a loved support person.
• 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.
• PATIENT: Resides outside of the United States.
• SUPPORT PERSON AND PROVIDERS: Resides outside of the United States.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (PACT); Participants use PACT mHealth app.	Other: Questionnaire Administration; Ancillary studies; Other: Internet-Based Intervention; Use smartphone application
Active Comparator: Arm II (standard care); Participants engage in standard care with no modifications.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Engage in standard care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Accrual rates [Patients]	Will assess the percentage of eligible approached patients who consent to enroll in the study	At 3 months post-randomization
Feasibility: Rates of intervention completion [Patients]	Will assess the percentage of enrolled patients who complete the intervention	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.	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	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	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.	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.	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).	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).	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).	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).	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.	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.	Baseline to 6 months post-intervention
Feasibility: Accrual rates [Support persons]	Will assess the percentage of eligible approached support persons who consent to enroll in the study	At 3 months post-randomization
Feasibility: Rates of intervention completion [Support persons]	Will assess the percentage of enrolled support persons who complete the intervention	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.	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	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	At 3 months post-randomization
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.	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.	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).	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).	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).	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).	Baseline to 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	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.	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.	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).	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).	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.	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Megan J Shen, PhD, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

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• Mack 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.
• Wright 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.
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• Detering 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.
• Brinkman-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.
• 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.
• Tariman 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.
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• Sudore 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.
• Kissane 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.
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• Garrido 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.
• Garrido 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.
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• Singer PA, Martin DK, Lavery JV, Thiel EC, Kelner M, Mendelssohn DC. Reconceptualizing advance care planning from the patient's perspective. Arch Intern Med. 1998 Apr 27;158(8):879-84. doi: 10.1001/archinte.158.8.879.
• Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2.
• Schobel M, Rieskamp J, Huber R. Social Influences in Sequential Decision Making. PLoS One. 2016 Jan 19;11(1):e0146536. doi: 10.1371/journal.pone.0146536. eCollection 2016.
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• Bangor A, Kortum P, Miller J. Determining What Individual SUS Scores Mean: Adding an Adjective Rating Scale. Journal of Usability Studies. 2009;4(3):114-123.
• Brooke J. SUS: A Retrospective. Journal of Usability Studies. 2013;8(2):29-40.
• Badr H, Smith CB, Goldstein NE, Gomez JE, Redd WH. Dyadic psychosocial intervention for advanced lung cancer patients and their family caregivers: results of a randomized pilot trial. Cancer. 2015 Jan 1;121(1):150-8. doi: 10.1002/cncr.29009. Epub 2014 Sep 10.
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Helpful Links

• Usability.gov. System Usability Scale (SUS)
• Measuring Usability with the System Usability Scale

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Advance Care Planning; Advance Directives; End-of-Life
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Liver Neoplasms; Esophageal Diseases; Neoplasms; Lung Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Adenocarcinoma; Genital Neoplasms, Female; Esophageal Neoplasms
• Other Study ID Numbers: RG1121852; 10849 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R37CA246703 (U.S. NIH Grant/Contract); NCI-2022-00398 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No