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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04515810
• Other study ID #: RG1121852
• Secondary ID: R37CA246703NCI-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Claudia De Los Santos, B.S.
• Phone: 206-667-1565
• Email: cdelossa[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Solid Neoplasm

Intervention

Other:
• Internet-Based Intervention
Use smartphone application
• Best Practice
Engage in standard care
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Northwell Health	Manhasset	New York
United States	Mount Sinai Hospital	New York	New York
United States	NYP/Weill Cornell Medical Center	New York	New York
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (32)

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. — View Citation

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.

Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173. — View Citation

Bernard H. Research methods in anthropology: qualitative and quantitative approaches. Lanham, MD: AltaMira; 2005

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. — View Citation

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. — View Citation

Brooke J. SUS: A Retrospective. Journal of Usability Studies. 2013;8(2):29-40.

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. — View Citation

Dow 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. — View Citation

Edwards 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Johnson S, Butow P, Kerridge I, Tattersall M. Advance care planning for cancer patients: a systematic review of perceptions and experiences of patients, families, and healthcare providers. Psychooncology. 2016 Apr;25(4):362-86. doi: 10.1002/pon.3926. Epub 2015 Sep 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Muller D, Judd CM, Yzerbyt VY. When moderation is mediated and mediation is moderated. J Pers Soc Psychol. 2005 Dec;89(6):852-63. doi: 10.1037/0022-3514.89.6.852. — View Citation

Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. doi: 10.1111/j.1532-5415.1975.tb00927.x. — View Citation

Preacher KJ, Rucker DD, Hayes AF. Addressing Moderated Mediation Hypotheses: Theory, Methods, and Prescriptions. Multivariate Behav Res. 2007 Jan-Mar;42(1):185-227. doi: 10.1080/00273170701341316. — View Citation

S. Summers and A. Watt,

Sandelowski M. What's in a name? Qualitative description revisited. Res Nurs Health. 2010 Feb;33(1):77-84. doi: 10.1002/nur.20362. — View Citation

Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14. — View Citation

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. — View Citation

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. — View Citation

Sobel ME. Asymptotic confidence intervals for indirect effects in structural equation models. Sociological Methodology. 1982;13:290-312.

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. — View Citation

Sullivan-Bolyai S, Bova C, Harper D. Developing and refining interventions in persons with health disparities: the use of qualitative description. Nurs Outlook. 2005 May-Jun;53(3):127-33. doi: 10.1016/j.outlook.2005.03.005. — View Citation

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. — View Citation

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Accrual rates [Patients]	Will assess the percentage of eligible approached patients who consent to enroll in the study	At 3 months post-randomization
Primary	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
Primary	Feasibility: Rates of intervention completion [Patients]	Will assess the percentage of enrolled patients who complete the intervention	At 3 months post-randomization
Primary	Feasibility: Rates of intervention completion [Support persons]	Will assess the percentage of enrolled support persons who complete the intervention	At 3 months post-randomization
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 a = 0.84 to 0.92).	Baseline to 3 months
Secondary	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 a = 0.84 to 0.92).	Baseline to 6 months
Secondary	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
Secondary	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

External Links

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