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Recruiting NCT04515810

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

No phase Interventional Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Recurrent Hematologic Malignancy Refractory Hematologic Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Intervention, Best Practice, Telephone-Based Intervention, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy, Refractory Hematologic Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Internet-Based Intervention
    Use smartphone application
  • Other Best Practice
    Engage in standard care
  • Other Telephone-Based Intervention
    Receive check-in call
  • Other Questionnaire Administration
    Ancillary studies
  • Other Post-intervention qualitative feedback interview
    Post-intervention qualitative feedback interview (with a subset of patients and support persons)

Primary outcome measures

  • Feasibility: Accrual rates [Patients] [Time frame: At 3 months post-randomization]
  • Feasibility: Accrual rates [Support persons] [Time frame: At 3 months post-randomization]
  • Feasibility: Rates of intervention completion [Patients] [Time frame: At 3 months post-randomization]
  • Feasibility: Rates of intervention completion [Support persons] [Time frame: At 3 months post-randomization]
  • Acceptability of the PACT application: Acceptability E-Scale [Patients] [Time frame: At 3 months post-randomization]
  • Acceptability of the PACT application: Acceptability E-Scale [Support persons] [Time frame: At 3 months post-randomization]
  • Usability of the PACT application: System Usability Scale (SUS) [Patients] [Time frame: At 3 months post-randomization]
  • Usability of the PACT application: System Usability Scale (SUS) [Support persons] [Time frame: At 3 months post-randomization]
  • User satisfaction [Patients] [Time frame: At 3 months post-randomization]
  • User satisfaction [Support persons] [Time frame: At 3 months post-randomization]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 4 centers
  • Northwell Health — Manhasset
  • Mount Sinai Hospital — New York
  • NYP/Weill Cornell Medical Center — New York
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

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. PMID 5212297
  • 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. PMID 20974066
  • S. 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. PMID 19565283
  • 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. PMID 24039772
  • 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. PMID 20124172
  • Zimet 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. PMID 2280326
  • 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. PMID 14526887

Identifiers

NCT: NCT04515810 · RG1121852 · R37CA246703 · NCI-2022-00398 · 10849

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗