Caregiver-guided pain coping skills training for patients with advanced cancer: Background,design,and challenges for the CaringPals study

Abstract

Background/Aims

Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes.

Methods

A total of 214 patients age ≥18 with Stage III–Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient–caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient’s death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain.

Results

This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient’s death.

Conclusion

The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.

Keywords

Advanced cancer cancer pain caregiving research design

Get full access to this article

View all access options for this article.

References

Kutner

Bryant

Beaty

et al . Time course and characteristics of symptom distress and quality of life at the end of life. J Pain Symptom Manage 2007; 34(3): 227–236.

Martinez

Aslakson

Wilson

et al . A systematic review of health care interventions for pain in patients with advanced cancer. Am J Hosp Palliat Care 2014; 31(1): 79–86.

Van den

Beuken-van

Everdingen

de Rijke

Kessels

et al . High prevalence of pain in patients with cancer in a large population-based study in The Netherlands. Pain 2007; 132(3): 312–320.

Wilkie

Ezenwa

MO.

Pain and symptom management in palliative care and at end of life. Nurs Outlook 2012; 60: 357–364.

Hackett

Godfrey

Bennett

MI.

Patient and caregiver perspectives on managing pain in advanced cancer: a qualitative longitudinal study. Palliat Med 2016; 30(8): 711–719.

Miaskowski

Zimmer

Barrett

et al . Differences in patients’ and family caregivers’ perceptions of the pain experience influence patient and caregiver outcomes. Pain 1997; 72(1–2): 217–226.

Hodges

Humphris

Macfarlane

A meta-analytic investigation of the relationship between the psychological distress of cancer patients and their carers. Soc Sci Med 2005; 60(1): 1–12.

Teno

Gruneir

Schwartz

et al . Association between advance directives and quality of end-of-life care: a national study. J Am Geriatr Soc 2007; 55(2): 189–194.

Foley

Arbit

Management of cancer pain. In: Hellman

VTDS

Rosenberg

(eds) Principles and practice of oncology. 3rd ed. Philadelphia, PA: J.B. Lippincott, 1989, pp. 2064–2087.

10.

Cleeland

CS.

Documenting barriers to cancer pain management. In: Chapman

Foley

(eds) Current and emerging issues in cancer pain management: research and practice. New York: Raven Press, 1993, pp 321–30.

11.

Gordon

Dahl

Miaskowski

et al . American Pain Society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force. Arch Intern Med 2005; 165(14): 1574–1580.

12.

Syrjala

Jensen

Mendoza

et al . Psychological and behavioral approaches to cancer pain management. J Clin Oncol 2014; 32(16): 1703–1711.

13.

Juarez

Ferrell

BR.

Family and caregiver involvement in pain management. Clin Geriatr Med 1996; 12(3): 531–547.

14.

Magrum

Bentzen

Landmark

Pain management in home care. Semin Oncol Nurs 1996; 12: 202–218.

15.

Ferrell

Cohen

Rhiner

et al . Pain as a metaphor for illness. Oncol Nurs Forum 1991; 18(8): 1315–1321.

16.

Blanchard

Albrecht

Ruckdeschel

JC.

The crisis of cancer: psychological impact on family caregivers. Oncology 1997; 11(2): 189–194; discussion 96, 201–202.

17.

Ferrell

Rhiner

et al . Family factors influencing cancer pain management. Postgrad Med J 1991; 67(Suppl. 2): S64–S19.

18.

Lin

Chou

et al . Long-term effectiveness of a patient and family pain education program on overcoming barriers to management of cancer pain. Pain 2006; 122(3): 271–281.

19.

Schulz

Beach

Lind

et al . Involvement in caregiving and adjustment to death of a spouse: findings from the caregiver health effects study. JAMA 2001; 285(24): 3123–3129.

20.

McHorney

Mor

Predictors of bereavement depression and its health services consequences. Med Care 1988; 26(9): 882–893.

21.

Jonasson

Hauksdottir

Valdimarsdottir

et al . Unrelieved symptoms of female cancer patients during their last months of life and long-term psychological morbidity in their widowers: a nationwide population-based study. Eur J Cancer 2009; 45(10): 1839–1845.

22.

Keefe

Ahles

Sutton

et al . Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3): 263–272.

23.

Schulz

Altman

Moher

CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010; 340: c322.

24.

Patrick

Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Value Health 2013; 16(4): 455–456.

25.

Cleeland

Ryan

KM.

Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994; 23(2): 129–138.

26.

Van Ryn

Sanders

Kahn

et al . Objective burden, resources, and other stressors among informal cancer caregivers: a hidden quality issue. Psychooncology 2011; 20(1): 44–52.

27.

Simmons

CPL

McMillan

McWilliams

et al . Prognostic tools in patients with advanced cancer: a systematic review. J Pain Symptom Manage 2017; 53(5): 962–970.e10.

28.

Harris

Taylor

Thielke

et al . Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377–381.

29.

Porter

Keefe

Baucom

et al . A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer. Psychooncology 2017; 26(7): 1027–1035.

30.

Lorig

Chastain

Ung

et al . Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum 1989; 32(1): 37–44.

31.

Keefe

Ahles

Porter

et al . The self-efficacy of family caregivers for helping cancer patients manage pain at end-of-life. Pain 2003; 103(1–2): 157–162.

32.

Porter

Keefe

Garst

et al . Self-efficacy for managing pain, symptoms, and function in patients with lung cancer and their informal caregivers: associations with symptoms and distress. Pain 2008; 137(2): 306–315.

33.

Lawton

Kleban

Moss

et al . Measuring caregiving appraisal. J Gerontol 1989; 44(3): P61–P71.

34.

Iecovich

Do caregiving burden and satisfaction predict loneliness in older care recipients. Aging Ment Health 2016; 20(4): 441–449.

35.

Robinson

BC.

Validation of a caregiver strain index. J Gerontol 1983; 38(3): 344–348.

36.

Miaskowski

Kragness

Dibble

et al . Differences in mood states, health status, and caregiver strain between family caregivers of oncology outpatients with and without cancer-related pain. J Pain Symptom Manage 1997; 13(3): 138–147.

37.

Porter

Keefe

Garst

et al . Caregiver-assisted coping skills training for lung cancer: results of a randomized clinical trial. J Pain Symptom Manage 2011; 41(1): 1–13.

38.

Porter

Keefe

Baucom

et al . Partner-assisted emotional disclosure for GI cancer: results of a randomized clinical trial. Cancer 2009; 115: 4326–4338.

39.

Porter

Keefe

Hurwitz

et al . Disclosure between patients with gastrointestinal cancer and their spouses. Psychooncology 2005; 14(12): 1030–1042.

40.

Pistrang

Barker

The partner relationship in psychological response to breast cancer. Soc Sci Med 1995; 40(6): 789–797.

41.

Manne

Badr

Zaider

et al . Cancer-related communication, relationship intimacy, and psychological distress among couples coping with localized prostate cancer. J Cancer Surviv 2010; 4(1): 74–85.

42.

Andresen

Malmgren

Carter

et al . Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med 1994; 10(2): 77–84.

43.

Irwin

Artin

Oxman

MN.

Screening for depression in the older adult: criterion validity of the 10-item Center for Epidemiological Studies Depression Scale (CES-D). Arch Intern Med 1999; 159(15): 1701–1704.

44.

Andresen

Byers

Friary

et al . Performance of the 10-item Center for Epidemiologic Studies Depression scale for caregiving research. SAGE Open Med. Epub ahead of print 2 December 2013. DOI: 10.1177/2050312113514576.

45.

Spielberger

Gorsuch

RL.

Manual for the state-trait anxiety inventory (form Y) (“Self-evaluation Questionnaire”). Palo Alto, CA: Consulting Psychologists Press, 1983.

46.

Spielberger

Reheiser

. Measuring anxiety, anger, depression, and curiosity as emotional states and personality traits with the STAI, STAXI and STPI. In: Hilsenroth

Segal

(eds) Comprehensive handbook of psychological assessment (personality assessment), vol. 2. Hoboken, NY: Wiley, 2004, pp. 70–83.

47.

Miaskowski

Cataldo

Baggott

et al . Cytokine gene variations associated with trait and state anxiety in oncology patients and their family caregivers. Support Care Cancer 2015; 23(4): 953–965.

48.

LaRue

Bank

Jarvik

et al . Health in old age: how do physicians’ ratings and self-ratings compare. J Gerontol 1979; 34(5): 687–691.

49.

Mossey

Shapiro

Self-rated health: a predictor of mortality among the elderly. Am J Public Health 1982; 72(8): 800–808.

50.

Wagner

LaCroix

Grothaus

et al . Responsiveness of health status measures to change among older adults. J Am Geriatr Soc 1993; 41(3): 241–248.

51.

Anderson

Dowds

Pelletz

et al . Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain. Pain 1995; 63(1): 77–84.

52.

Daut

Cleeland

Flanery

RC.

Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 1983; 17(2): 197–210.

53.

Porter

Keefe

Lipkus

et al . Ambivalence over emotional expression in patients with gastrointestinal cancer and their caregivers: associations with patient pain and quality of life. Pain 2005; 117(3): 340–348.

54.

Somers

Kelleher

Westbrook

et al . A small randomized controlled pilot trial comparing mobile and traditional pain coping skills training protocols for cancer patients with pain. Pain Res Treat 2016; 2016: 2473629.

55.

Carroll

Kathol

Noyes

Jr et al . Screening for depression and anxiety in cancer patients using the Hospital Anxiety and Depression Scale. Gen Hosp Psychiatry 1993; 15(2): 69–74.

56.

Moorey

Greer

Watson

et al . The factor structure and factor stability of the hospital anxiety and depression scale in patients with cancer. Br J Psychiatry 1991; 158: 255–259.

57.

Hopwood

Howell

Maguire

Screening for psychiatric morbidity in patients with advanced breast cancer: validation of two self-report questionnaires. Br J Cancer 1991; 64(2): 353–356.

58.

Miaskowski

. Self-care activities for pain (2015, Personal communication).

59.

Chang

Hwang

Kasimis

et al . Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS). Cancer Invest 2004; 22(4): 526–536.

60.

Dhingra

Barrett

Knotkova

et al . Symptom distress among diverse patients referred for community-based palliative care: sociodemographic and medical correlates. J Pain Symptom Manage 2018; 55(2): 290–296.

61.

Dhingra

Dieckmann

Knotkova

et al . A high-touch model of community-based specialist palliative care: latent class analysis identifies distinct patient subgroups. J Pain Symptom Manage 2016; 52(2): 178–186.

62.

Miaskowski

Dodd

West

et al . Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9): 1713–1720.

63.

Miaskowski

Dodd

West

et al . Lack of adherence with the analgesic regimen: a significant barrier to effective cancer pain management. J Clin Oncol 2001; 19(23): 4275–4279.

64.

Miaskowski

Mack

Dodd

et al . Oncology outpatients with pain from bone metastasis require more than around-the-clock dosing of analgesics to achieve adequate pain control. J Pain 2002; 3(1): 12–20.

65.

MastersSteedman

Middaugh

Kee

et al . Chronic pain medications: equivalence levels and method of quantifying usage. Clin J Pain 1992; 8(3): 204–214.

66.

Keefe

Ahles

Sutton

et al . Partner-guided pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29: 263–272.

67.

Syrjala

Abrams

DuPen

et al . Relieving cancer pain. Seattle, WA: Fred Hutchinson Cancer Research Center, 1993.

68.

Syrjala

Rupert

DuPen

et al . Relieving cancer pain (videotape). Seattle, WA: Fred Hutchinson Cancer Research Center, 1997.

69.

Gunnarsdottir

Donovan

Serlin

et al . Patient-related barriers to pain management: the Barriers Questionnaire II (BQ-II). Pain 2002; 99: 385–396.

70.

Syrjala

Donaldson

Davis

et al . Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial. Pain 1995; 63(2): 189–198.

71.

Porter

Keefe

Baucom

et al . Partner-assisted emotional disclosure for patients with gastrointestinal cancer: results from a randomized controlled trial. Cancer 2009; 115(18 Suppl.): 4326–4338.

72.

Gil

Ross

Keefe

FJ.

Behavioral treatment of chronic pain: four pain management protocols. In: France

Krishnan

KRR

(eds) Chronic pain. New York: American Psychiatric Press, 1988, pp. 376–413.

73.

Keefe

Van Horn

Cognitive-behavioral treatment of rheumatoid arthritis pain: understanding and enhancing maintenance of treatment gains. Arthritis Care Res 1993; 6: 213–222.

74.

SAS Institute. SAS/ACCESS^® 9.4 interface to ADABAS: reference. Cary, NC: SAS Institute, 2013.

75.

Raudenbush

Bryk

AS.

Hierarchical linear models: applications and data analysis methods. 2nd ed. Thousand Oaks, CA: SAGE, 2002.

76.

Singer

Willett

JB.

Modeling the days of our lives: using survival analysis when designing and analyzing longitudinal studies of duration and the timing of events. Psychol Bull 1991; 110: 268–290.

77.

Graham

Hofer

Donaldson

et al . Analysis with missing data in prevention research. In: Bryant

Windle

West

(eds) The science of prevention: methodological advances from alcohol and substance abuse research. Washington, DC: American Psychological Association, 1997, pp. 325–366.

78.

Hedeker

Gibbons

RD.

Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychol Methods 1997; 2: 64–78.

79.

Cohen

Statistical power analysis for the behavioral sciences. 2nd ed. New York: Lawrence Erlbaum Associates, 1988.

80.

Moss

Lunney

Culp

et al . Prognostic significance of the “surprise” question in cancer patients. J Palliat Med 2010; 13(7): 837–840.

81.

Temel

Gainor

Sullivan

et al . Keeping expectations in check with immune checkpoint inhibitors. J Clin Oncol 2018; 36(17): 1654–1657.

82.

Temel

Greer

Muzikansky

et al . Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010; 363(8): 733–742.

83.

Bakitas

Lyons

Hegel

et al . Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA 2009; 302(7): 741–749.

84.

Van den

Beuken-van

Everdingen

Hochstenbach

Joosten

et al . Update on prevalence of pain in patients with cancer: systematic review and meta-analysis. J Pain Symptom Manage 2016; 51(6): 1070–1090.e9.

85.

Herr

Pain assessment strategies in older patients. J Pain 2011; 12(3 Suppl. 1): S3–S13.

86.

White

Hardy

What do palliative care patients and their relatives think about research in palliative care? A systematic review. Support Care Cancer 2010; 18(8): 905–911.