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BMC Palliative Care
Published in: BMC Palliative Care 1/2022

Open Access 01-12-2022 | Mood Disorders | Study protocol

A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol

Authors: Joanna J. Arch, Jill L. Mitchell, Sarah J. Schmiege, Michael E. Levin, Sarah R. Genung, Madeline S. Nealis, Regina M. Fink, Emma E. Bright, David J. Andorsky, Jean S. Kutner

Published in: BMC Palliative Care | Issue 1/2022

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Abstract

Background

Up to half of adults with advanced cancer report anxiety or depression symptoms, which can cause avoidance of future planning. We present a study protocol for an innovative, remotely-delivered, acceptance-based, multi-modal palliative care intervention that addresses advance care planning (ACP) and unmet psychological needs commonly experienced by adults with metastatic cancer.

Methods

A two-armed, prospective randomized controlled trial (RCT) randomizes 240 adults with Stage IV (and select Stage III) solid tumor cancer who report moderate to high anxiety or depression symptoms to either the multi-modal intervention or usual care. The intervention comprises five weekly two-hour group sessions (plus a booster session one month later) delivered via video conferencing, with online self-paced modules and check-ins completed between the group sessions. Intervention content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based model. Participants are recruited from a network of community cancer care clinics, with group sessions led by the network’s oncology clinical social workers. Participants are assessed at baseline, mid-intervention, post-intervention, and 2-month follow-up. The primary outcome is ACP completion; secondary outcomes include anxiety and depression symptoms, fear of dying, and sense of life meaning. Relationships between anxiety/depression symptoms and ACP will be evaluated cross-sectionally and longitudinally and theory-based putative mediators will be examined.

Discussion

Among adults with advanced cancer in community oncology settings, this RCT will provide evidence regarding the efficacy of the group ACT intervention on ACP and psychosocial outcomes as well as examine the relationship between ACP and anxiety/ depression symptoms. This trial aims to advance palliative care science and inform clinical practice.

Trial Registration

Clinicaltrials.gov NCT04773639 on February 26, 2021.
Literature
1.
Pizzo P, Walker D, Bomba P. Dying in America: Improving quality and honoring individual preferences near the end of life. Washington, DC: Institute of Medicine; 2014.
2.
National Institute of Nursing Research. The NINR Strategic Plan: Advancing Science, Improving Lives. A Vision for Nursing Science. Bethesda: NIH publication #16-NR-7783; 2016.
3.
Orkin AM, Gill PJ, Ghersi D, Campbell L, Sugarman J, Emsley R, et al. Guidelines for reporting trial protocols and completed trials modified due to the COVID-19 pandemic and other extenuating circumstances: The CONSERVE 2021 statement. JAMA. 2021;326(3):257–65.PubMedCrossRef
4.
Hong Y, Pena-Purcell NC, Ory MG. Outcomes of online support and resources for cancer survivors: A systematic literature review. Patient Educ Couns. 2011;86:288–96.PubMedCrossRef
5.
Edelman S, Bell DR, Kidman AD. A group cognitive behaviour therapy programme with metastatic breast cancer patients. Psycho-oncology. 1999;8(4):295–305.PubMedCrossRef
6.
Vainio A, Auvinen A, Group SP. Prevalence of symptoms among patients with advanced cancer: an international collaborative study. J Pain Symptom Manag. 1996;12(1):3–10.CrossRef
7.
8.
Vehling S, Lehmann C, Oechsle K, Bokemeyer C, Krüll A, Koch U, et al. Is advanced cancer associated with demoralization and lower global meaning? The role of tumor stage and physical problems in explaining existential distress in cancer patients. Psycho-oncology. 2012;21(1):54–63.PubMedCrossRef
9.
10.
Grabsch B, Clarke DM, Love A, McKenzie DP, Snyder RD, BLock S, et al. Psychological morbidity and quality of life in women with advanced breast cancer: a cross-sectional survey. Palliat Supportive Care. 2006;4:47–56.CrossRef
11.
Greco MT, Roberto A, Corli O, Deandrea S, Bandieri E, Cavuto S, et al. Quality of cancer pain management: an update of a systematic review of undertreatment of patients with cancer. J Clin Oncol. 2014;32(36):4149–54.PubMedCrossRef
12.
Sudore RL, Lum HD, You JJ, Hanson LC, Meier DE, Pantilat SZ, et al. Defining advance care planning for adults: a consensus definition from a multidisciplinary Delphi panel. J Pain Symptom Manag. 2017;53(5):821–32. e1.CrossRef
13.
Rose JH, Radziewicz R, Bowman KF, O’Toole EE. A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Clin Interv Aging. 2008;3(1):77–95.PubMedPubMedCentralCrossRef
14.
Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, et al. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011;12(8):753–62.PubMedPubMedCentralCrossRef
15.
Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: An effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015;33(7):749–54.PubMedPubMedCentralCrossRef
16.
Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manag. 2007;34(1):94–104.CrossRef
17.
Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, et al. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011;12(2):160–74.PubMedCrossRef
18.
Lloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004;18(6):558–63.PubMedCrossRef
19.
Delgado-Guay M, Parsons HA, Li Z, Palmer JL, Bruera E. Symptom distress in advanced cancer patients with anxiety and depression in the palliative care setting. Support Care Cancer. 2009;17(5):573–9.PubMedCrossRef
20.
Cohen L, Cole SW, Sood AK, Prinsloo S, Kirschbaum C, Arevalo JM, et al. Depressive symptoms and cortisol rhythmicity predict survival in patients with renal cell carcinoma: role of inflammatory signaling. PLoS ONE. 2012;7(8):e42324.PubMedPubMedCentralCrossRef
21.
Armaiz-Pena GN, Cole SW, Lutgendorf SK, Sood AK. Neuroendocrine influences on cancer progression. Brain Behav Immun. 2013;30:19–25.CrossRef
22.
Antoni MH, Lutgendorf SK, Cole SW, Dhabhar FS, Sephton SE, McDonald PG, et al. The influence of bio-behavioural factors on tumour biology: pathways and mechanisms. Nat Rev Cancer. 2006;6(3):240–8.PubMedPubMedCentralCrossRef
23.
Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, et al. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer. J Clin Oncol. 2012;30(12):1304–9.PubMedPubMedCentralCrossRef
24.
25.
Angiola JE, Bowen AM. Quality of life in advanced cancer: An acceptance and commitment therapy view. Couns Psychol. 2013;41(2):313–35.CrossRef
26.
Hayes SC, Wilson KG, Gifford EV, Follette VM, Strosahl K. Experiential avoidance and behavioral disorders: A functional dimensional approach to diagnosis and treatment. J Consult Clin Psychol. 1996;64(6):1152–68.PubMedCrossRef
27.
Forsyth JP, Eifert GH, Barrios V. Fear conditioning in an emotion regulation context: A fresh perspective on the origins of anxiety disorders. In: Craske MG, Hermans D, Vansteenwegen D, editors. From basic processes to clinical implications. Washington, D.C.: American Psychological Association; 2006. pp. 133–53.CrossRef
28.
Rost AD, Wilson KG, Buchanan E, Hildebrandt MJ, Mutch D. Improving psychological adjustment among late-stage ovarian cancer patients: Examining the role of avoidance in treatment. Cogn Behav Pract. 2012;19:508–17.CrossRef
29.
Stanton AL, Danoff-Burg S, Cameron CL, Bishop M, Collins CA, Kirk SB, et al. Emotionally expressive coping predicts psychological and physical adjustment to breast cancer. J Consult Clin Psychol. 2000;68(5):875–82.PubMedCrossRef
30.
Stanton AL, Snider PR. Coping with a breast cancer diagnosis: A prospective study. Health Psychol. 1993;12(1):16–23.PubMedCrossRef
31.
Park CL, Edmondson D, Fenster JR, Blank TO. Meaning making and psychological adjustment following cancer: the mediating roles of growth, life meaning, and restored just-world beliefs. J Consult Clin Psychol. 2008;76(5):863–75.PubMedCrossRef
32.
Arch JJ, Mitchell J. An acceptance and commitment therapy group intervention for cancer survivors experiencing anxiety at reentry. Psycho-oncology. 2016;25(5):610–5.PubMedCrossRef
33.
Arch JJ, Wolitzky-Taylor KB, Eifert GH, Craske MG. Longitudinal treatment mediation of traditional cognitive behavioral therapy and acceptance and commitment therapy for anxiety disorders. Behav Res Ther. 2012;50(7–8):469–78.PubMedCrossRef
34.
Clauser SB, Johnson MR, O’Brien DM, Beveridge JM, Fennell ML, Kaluzny AD. Improving clinical research and cancer care delivery in community settings: evaluating the NCI community cancer centers program. Implement Sci. 2009;4:1–11.CrossRef
35.
Schenker Y, Arnold R. Toward palliative care for all patients with advanced cancer. JAMA Oncol. 2017;3(11):1459–60.PubMedCrossRef
36.
Lupu D. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manag. 2010;40(6):899–911.CrossRef
37.
Institute of Medicine. Dying in America: Improving quality and honoring individual preferences near the end of life. Washington, DC: National Academies Press; 2014.
38.
Lo C, Hales S, Jung J, Chiu A, Panday T, Rydall A, et al. Managing Cancer And Living Meaningfully (CALM): Phase 2 trial of a brief individual psychotherapy for patients with advanced cancer. Palliat Care. 2014;28(3):234–42.
39.
Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015;33(7):749–54.PubMedPubMedCentralCrossRef
40.
Waller R, Gilbody S. Barriers to the uptake of computerized cognitive behavioural therapy: a systematic review of the quantitative and qualitative evidence. Psychol Med. 2009;39(5):705–12.PubMedCrossRef
41.
Baumeister H, Reichler L, Munzinger M, Lin J. The impact of guidance on Internet-based mental health interventions—A systematic review. Internet Interventions. 2014;1(4):205–15.CrossRef
42.
Arch JJ, Fishbein JN, Ferris M, Mitchell JL, Levin ME, Andorsky DJ, et al. Acceptability, feasibility, and potential for efficacy of an acceptance-based intervention to address psychosocial and advance care planning needs among anxious and depressed adults with metastatic cancer. J Palliat Med. 2020;23(10):1380–5.PubMedCrossRef
43.
Matis J, Svetlak M, Slezackova A, Svoboda M, Šumec R. Mindfulness-based programs for patients with cancer via eHealth and mobile health: systematic review and synthesis of quantitative research. J Med Internet Res. 2020;22(11):e20709.PubMedPubMedCentralCrossRef
44.
SAS Institute. Statistical Analysis Software. Users’ Guide Statistics Version 9.4. Cary: SAS Institute; 2013.
45.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
46.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, Mcfadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–56.PubMedCrossRef
47.
Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613–21.PubMed
48.
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia–Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–77.PubMedPubMedCentralCrossRef
49.
Arch JJ, Crespi CM, Levin ME, Genung SR, Nealis M, Mitchell JL, et al. Randomized controlled pilot trial of a low-touch remotely-delivered values intervention to promote adherence to adjuvant endocrine therapy among breast cancer survivors. Annals of Behavioral Medicine. in press.
50.
51.
Bailey A, Ciarrochi J, Harris R. The Weight Escape: How to stop dieting and start living. Boulder: Shambhala Publications; 2014.
52.
53.
Beidas RS, Kendall PC. Training therapists in evidence-based practice: A critical review of studies from a systems‐contextual perspective. Clin Psychol Sci Pract. 2010;17(1):1–30.CrossRef
54.
Kroenke K, Spitzer RL, Williams JBW, Monahan PO, Lowe B. Anxiety disorders in primary care: Prevalance, impairment, comorbidity, and detection. Ann Intern Med. 2007;146:317–25.PubMedCrossRef
55.
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284–92.PubMedCrossRef
56.
Wu Y, Levis B, Riehm KE, Saadat N, Levis AW, Azar M, et al. Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis. Psychol Med. 2020;50(8):1368–80.PubMedCrossRef
57.
Hinz A, Mehnert A, Kocalevent R-D, Brähler E, Forkmann T, Singer S, et al. Assessment of depression severity with the PHQ-9 in cancer patients and in the general population. BMC Psychiatry. 2016;16(1):1–8.CrossRef
58.
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.PubMedCrossRef
59.
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: The functional assessment of chronic illness therapy - Spiritual well-being scale (FACIT-Sp). Ann Behav Med. 2002;24(1):49–58.PubMedCrossRef
60.
Nelson C, Jacobson CM, Weinberger MI, Bhaskaran V, Rosenfeld B, Breitbart W, et al. The role of spirituality in the relationship between religiosity and depression in prostate cancer patients. Ann Behav Med. 2009;38(2):105–14.PubMedCrossRef
61.
Visser A, Garssen B, Vingerhoets A. Spirituality and well-being in cancer patients: a review. Psycho‐oncology. 2010;19(6):565–72.PubMedCrossRef
62.
Wong PT, Reker GT, Gesser G. Death Attitude Profile-Revised: A multidimensional measure of attitudes toward death. Death anxiety handbook: Research, instrumentation, and application. 1994;121.
63.
Clements R, Rooda LA. Factor structure, reliability, and validity of the death attitude profile-revised. OMEGA-Journal of Death and Dying. 2000;40(3):453–63.CrossRef
64.
Fresco DM, Moore MT, Van Dulmen MHM, Segal ZV, Ma SH, Teasdale JD, et al. Initial psychometric properties of the experiences questionnaire: Validation of a self-report measure of decentering. Behav Ther. 2007;38(3):234–46.PubMedCrossRef
65.
Soler J, Franquesa A, Feliu-Soler A, Cebolla A, García-Campayo J, Tejedor R, et al. Assessing decentering: validation, psychometric properties, and clinical usefulness of the experiences questionnaire in a Spanish sample. Behav Ther. 2014;45(6):863–71.PubMedCrossRef
66.
Smout M, Davies M, Burns N, Christie A. Development of the Valuing Questionnaire (VQ). J Context Behav Sci. 2014;3(3):164–72.CrossRef
67.
Gámez W, Chmielewski M, Kotov R, Ruggero C, Watson D. Development of a measure of experiential avoidance: The multidimensional experiential avoidance questionnaire. Psychol Assess. 2011;23(3):692–713.PubMedCrossRef
68.
Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In: Maruish ME, editor. The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults. Mahwah: Lawrence Erlbaum Associates Publishers; 2004. pp. 799–811.
69.
Attkisson CC, Zwick R. The Client Satisfaction Questionnaire: Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plan. 1982;5(3):233–7.CrossRef
70.
Raudenbush SW, Liu X. Statistical power and optimal design for multisite randomized trials. Psychol Methods. 2000;5(2):199–213.PubMedCrossRef
71.
Fritz MS, MacKinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007;18(3):233–9.PubMedCrossRef
72.
Singer J, Willet J. Applied longitudinal data analysis: Modeling change and event occurrence. New York: Oxford University Pres. Inc; 2003.CrossRef
73.
Muthén LK, Muthén BO. Mplus User’s Guide. Eighth Edition. Los Angeles: Muthen & Muthen; 1998–2017.
74.
Cheong J, MacKinnon DP, Khoo ST. Investigation of mediational processes using parallel process latent growth curve modeling. Struct Equ Model. 2003;10(2):238–62.CrossRef
75.
Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40(3):879–91.PubMedCrossRef
76.
Zhao X, Lynch JG Jr, Chen Q. Reconsidering Baron and Kenny: Myths and truths about mediation analysis. J Consum Res. 2010;37(2):197–206.CrossRef
77.
Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002;7(4):422–45.PubMedCrossRef
Metadata
Title
A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol
Authors
Joanna J. Arch
Jill L. Mitchell
Sarah J. Schmiege
Michael E. Levin
Sarah R. Genung
Madeline S. Nealis
Regina M. Fink
Emma E. Bright
David J. Andorsky
Jean S. Kutner
Publication date
01-12-2022
Publisher
BioMed Central
Published in
BMC Palliative Care / Issue 1/2022
Electronic ISSN: 1472-684X
DOI
https://doi.org/10.1186/s12904-022-01087-z

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