Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial

Laura S Porter, Katherine Ramos, Donald H Baucom, Karen Steinhauser, Alaattin Erkanli, Timothy J Strauman, S Yousuf Zafar, Devon K Check, Karena Leo, Evan Liu, Francis J Keefe, Laura S Porter, Katherine Ramos, Donald H Baucom, Karen Steinhauser, Alaattin Erkanli, Timothy J Strauman, S Yousuf Zafar, Devon K Check, Karena Leo, Evan Liu, Francis J Keefe

Abstract

Background: For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning.

Methods: This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings.

Discussion: This trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer.

Trial registration: This study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.

Keywords: Cancer; Caregivers; Communication; Randomized controlled trial; Videoconferencing.

Conflict of interest statement

The authors declare that they have no completing interests.

© 2022. The Author(s).

Figures

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Fig. 1
Study flow

References

    1. Ma Y, He B, Jiang M, Yang Y, Wang C, Huang C, et al. Prevalence and risk factors of cancer-related fatigue: a systematic review and meta-analysis. Int J Nurs Stud. 2020;111:103707. doi: 10.1016/j.ijnurstu.2020.103707.
    1. van den Beuken-van Everdingen MH, Hochstenbach LM, Joosten EA, et al. Update on prevalence of pain in patients with cancer: systematic review and meta-analysis. J Pain Symptom Manag. 2016;51:1070–1090. doi: 10.1016/j.jpainsymman.2015.12.340.
    1. Chen D, Yin Z, Fang B. Measurements and status of sleep quality in patients with cancers. Support Care Cancer. 2018;26:405–414. doi: 10.1007/s00520-017-3927-x.
    1. Schover LR. Sexual quality of life in men and women after cancer. Climacteric. 2019;22(6):553–557. doi: 10.1080/13697137.2018.1526893.
    1. Fitch MI, Allard M. Perspectives of husbands of women with breast cancer: impact and response. Can Oncol Nurs J. 2007;17:66–78. doi: 10.5737/1181912x1726671.
    1. Neo J, Fettes L, Gao W, Higginson IJ, Maddocks M. Disability in activities of daily living among adults with cancer: a systematic review and meta-analysis. Cancer Treat Rev. 2017;61:94–106. doi: 10.1016/j.ctrv.2017.10.006.
    1. Mitchell AJ, Chan M, Bhatti H. 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;12:160–174. doi: 10.1016/S1470-2045(11)70002-X.
    1. Pitman A, Suleman S, Hyde N, Hodgkiss A. Depression and anxiety in patients with cancer. BMJ. 2018;361(k1415). 10.1136/bmj.k1415.
    1. Griffiths C, Norton L, Wagstaff G, Brunas-Wagstaff J. Existential concerns in late stage cancer. Eur J Oncol Nurs. 2002;6(4):243-6.
    1. Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, et al. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studie. J Cancer Surviv. 2013;7(3):300–322. doi: 10.1007/s11764-013-0272-z.
    1. Vehling S, Philipp R. Existential distress and meaning-focused interventions in cancer survivorship. Curr Opin Support Palliat Care. 2018;12(1):46–51. doi: 10.1097/SPC.0000000000000324.
    1. McLean LM, Jones JM. A review of distress and its management in couples facing end-of-life cancer. Psychooncology. 2007;16:603–616. doi: 10.1002/pon.1196.
    1. Girgis A, Lambert S, Johnson C, Waller A, Currow D. Physical, psychosocial, relationship, and economic burden of caring for people with cancer: a review. J Oncol Pract. 2013;9:197–202. doi: 10.1200/JOP.2012.000690.
    1. Hasdenteufel M, Quintard B. Dyadic experiences and psychosocial management of couples facing advanced cancer: a systematic review of the literature. Front Psychol. 2022;13. 10.3389/fpsyg.2022.827947.
    1. Applebaum AJ, Kulikowski MA, Breitbart W. Meaning-centered psychotherapy for cancer caregivers (MCP-C): rationale and overview. Palliat Support Care. 2015;13(6):1631–1641. doi: 10.1017/S1478951515000450.
    1. Areia N, Fonseca G, Major S, Relvas A. Psychological morbidity in family caregivers of people living with terminal cancer: prevalence and predictors. Palliative Support Care. 2019;17:286–293. doi: 10.1017/S1478951518000044.
    1. Kuijer RG, Buunk BP, De Jong GM, Ybema JF, Sanderman R. Effects of a brief intervention program for patients with cancer and their partners on feelings of inequity, relationship quality, and psychological distress. Psychooncology. 2003;13:321–334. doi: 10.1002/pon.749.
    1. Baucom DH, Porter LS, Kirby JS, Hudepohl J. Couple-based interventions for medical problems. Behav Ther. 2012;43(1):61–76. doi: 10.1016/j.beth.2011.01.008.
    1. Donovan-Kicken E, Tollison AC, Goins ES. The nature of communication work during cancer: advancing the theory of illness trajectories. Health Commun. 2012;27(7):641–652. doi: 10.1080/10410236.2011.629405.
    1. Badr H, Krebs P. A systematic review and meta-analysis of psychosocial interventions for couples coping with cancer. Psycho-oncology. 2012;22(8):1688–1704. doi: 10.1002/pon.3200.
    1. Porter LS, Keefe FJ, Baucom DH, Hurwitz H, Moser B, Patterson E, et al. Partner-assisted emotional disclosure for patients with gastrointestinal cancer: Results from a randomized controlled trial. Cancer. 2009;115(S18):4326–4338. doi: 10.1002/cncr.24578.
    1. Porter LS, Keefe FJ, Baucom DH, Olsen M, Zafar SY, Uronis H. A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer. Psycho-oncology. 2017;26(7):1027–1035. doi: 10.1002/pon.4121.
    1. Manne SL, Kissane DW, Nelson CJ, Mulhall JP, Winkel G, Zaider T. Intimacy-enhancing psychological intervention for men diagnosed with prostate cancer and their partners: A pilot study. J Sex Med. 2011;8:1197–1209. doi: 10.1111/j.1743-6109.2010.02163.x.
    1. Porter LS, Keefe FJ, Hurwitz H, Faber M. Disclosure between patients with gastrointestinal cancer and their spouses. Psychooncology. 2005;14(12):1030–1042. doi: 10.1002/pon.915.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Pistrang N, Barker C. The partner relationship in psychological response to breast cancer. Soc Sci Med. 1995;40(6):789–797. doi: 10.1016/0277-9536(94)00136-H.
    1. Porter LS, Keefe FJ, Baucom DH, Hurwitz H, Moser B, Patterson ES, et al. Partner-assisted emotional disclosure for GI cancer: results of a randomized clinical trial. Cancer. 2009;115(S18):4326–38.
    1. Manne S, Badr H, Zaider T, Nelson C, Kissane D. Cancer-related communication, relationship intimacy, and psychological distress among couples coping with localized prostate cancer. J Cancer Surviv. 2010;4:74–85. doi: 10.1007/s11764-009-0109-y.
    1. Figueiredo M, Fries E, Ingram K. The role of disclosure patterns and unsupportive social interactions in the well-being of breast cancer patients. Psycho-oncology. 2004;13(2):96–105. doi: 10.1002/pon.717.
    1. Porter LS, Keefe FJ. Couple-based communication interventions for cancer: moving beyond a ‘one size fits all’ approach. Acta Oncol. 2018;57(5):693–695. doi: 10.1080/0284186X.2017.1400687.
    1. Epstein N, Baucom DH. Enhanced cognitive-behavioral therapy for couples: a contextual approach. Washington, DC: American Psychological Association; 2002.
    1. Baucom DH, Shoham V, Mueser KT, Daiuto AD, Stickle TR. Empirically supported couples and family therapies for adult problems. J Consult Clin Psychol. 1998;66:53–88. doi: 10.1037/0022-006X.66.1.53.
    1. Porter LS, Keefe FJ, Garst J, Baucom DH, McBride CM, McKee DC, et al. Caregiver-assisted coping skills training for lung cancer: results of a randomized clinical trial. J Pain Symptom Manag. 2011;41(1):1–13. doi: 10.1016/j.jpainsymman.2010.04.014.
    1. Miller RS, Lefcourt HM. The assessment of social intimacy. J Pers Assess. 1982;46(5):514–518. doi: 10.1207/s15327752jpa4605_12.
    1. Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007;21(4):572–583. doi: 10.1037/0893-3200.21.4.572.
    1. Carroll B, Kathol R, Noyes R, et al. Screening for depression and anxiety in cancer patients using the Hospital Anxiety and Depression Scale. Gen Hosp Psychiatry. 1993;15:69–74. doi: 10.1016/0163-8343(93)90099-A.
    1. Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54(6):1063–1070. doi: 10.1037/0022-3514.54.6.1063.
    1. Steinhauser KE, Bosworth HB, Clipp EC, McNeilly M, Christakis NA, Parker J, et al. An initial assessment of a new instrument to measure quality at the end of life (QUAL-E) J Palliat Med. 2002;5:829–841. doi: 10.1089/10966210260499014.
    1. Steinhauser KE, Clipp E, Bosworth H, McNeilly M, Christakis N, Voils C, et al. Measuring quality of life at the end of life: Validation of the QUAL-E. Palliative Support Care. 2004;2(1):3–14. doi: 10.1017/S1478951504040027.
    1. Moorey S, Greer S, Watson M, et al. The factor structure and factor stability of the hospital anxiety and depression scale in patients with cancer. Br J Psychiatry. 1991;158:2555–2259. doi: 10.1192/bjp.158.2.255.
    1. Steinhauser KE, Voils CI, Bosworth HB, Tulsky JA. Validation of the QUAL-E Fam: a measure of the quality of family experience of patients with serious illness: the QUAL-E Fam. J Pain Symptom Manag. 2014;48(6):1168–1181. doi: 10.1016/j.jpainsymman.2014.04.006.
    1. Steinhauser KE, Voils CI, Bosworth HB, Tulsky JA. Validation of a measure of family experience of patients with serious illness: the QUAL-E (Fam) J Pain Symptom Manag. 2014;48(6):1168–1181. doi: 10.1016/j.jpainsymman.2014.04.006.
    1. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570–579. doi: 10.1200/JCO.1993.11.3.570.
    1. Victorson D, Barocas J, Song J, Cella DR. Reliability across studies from the functional assessment of cancer therapy-general (FACT-G) and its subscales: a reliability generalization. Qual Life Res. 2008;17(9):1137–1146. doi: 10.1007/s11136-008-9398-2.
    1. Chang VT, Hwang SS, Kasimis B, Thaler HT. Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS) Cancer Investig. 2004;22(4):526–536. doi: 10.1081/CNV-200026487.
    1. Bircan HA, Yalcin GS, Fidanci S, Karaibrahimoglu A, Tuglu H. The usefulness and prognostic value of Memorial Symptom Assessment-Short Form and Condensed Memorial Symptom Assessment Scale in assessment of lung cancer patients. Support Care Cancer. 2020;28(4):2005–2014. doi: 10.1007/s00520-019-05003-9.
    1. Suls J, Green P, Rose G, Lounsbury P, Goden E. Hiding worries from One’s spouse: associations between coping via protective buffering and distress in male post-myocardial infarction patients and their wives. J Behav Med. 1997;20(4):333–349. doi: 10.1023/A:1025513029605.
    1. Langer SL, Brown JD, Syrjala KL. Intrapersonal and interpersonal consequences of protective buffering among cancer patients and caregivers. Cancer. 2009;115(18 Suppl):4311–4325. doi: 10.1002/cncr.24586.
    1. Pennebaker JW, Chung CK, Ireland M, Gonzales A, Booth RJ. The development and psychometric properties of LIWC2015. Austin: University of Texas at Austin; 2015.
    1. Badr H. New frontiers in couple-based interventions for cancer care: refining the prescription for spousal communication. Acta Oncol. 2017;56(2):139–145. doi: 10.1080/0284186X.2016.1266079.
    1. Rohrbaugh M, Shoham V, Skoyen J, Jensen M, Mehl MR. We-talk, communal coping, and cessation success in a couple-focused intervention for health-compromised smokers. Fam Process. 2012;51:107–121. doi: 10.1111/j.1545-5300.2012.01388.x.
    1. Badr H, Milbury K, Majeed N, Carmack CL, Ahmad Z, Gritz ER. Natural language use and couples’ adjustment to head and neck cancer. Health Psychol. 2016;35:1069–1080. doi: 10.1037/hea0000377.
    1. Williams-Baucom KJ, Atkins DC, Sevier M, Eldridge KA, Christensen A. “You” and “I” need to talk about “us”: linguistic patterns in marital interactions. Pers Relat. 2010;17:41–56. doi: 10.1111/j.1475-6811.2010.01251.x.
    1. Leo K, Crenshaw AO, Hogan JN, Bourne SV, Baucom KJW, Baucom BRW. A replication and extension of the interpersonal process model of demand/withdraw behavior: Incorporating subjective emotional experience. J Fam Psychol. 2021;35(4):534-45.
    1. Leo K, Leifker FR, Baucom DH, Baucom BRW. Conflict management and problem solving as relationship maintenance. In: Ogolsky BG, Monk JK, editors. Relationship Maintenance: Theory, Process, and Context. Cambridge: Cambridge University Press; 2019.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–1327. doi: 10.2105/AJPH.89.9.1322.
    1. Hedeker D, Gibbons R. Longitudinal data analysis. Hoboken: Wiley; 2006.
    1. Schafer J. Analysis of incomplete multivariate data. London: Chapman & Hall; 1997.
    1. Atkins D. Using multilevel models to analyze couple and family treatment data: Basic and advanced issues. J Fam Psychol. 2005;19(1):98–110. doi: 10.1037/0893-3200.19.1.98.
    1. Fitzmaurice G, Laird NM, Ware JH. Applied longitudinal analysis. New York: Wiley; 2004.
    1. Kraemer HC, Kiernan M, Essex M, Kupfer DJ. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008;27(2 (Suppl)):S101–S108. doi: 10.1037/0278-6133.27.2(Suppl.).S101.
    1. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877–883. doi: 10.1001/archpsyc.59.10.877.
    1. Preacher KJ, Zypher MJ, Zhang Z. A general multilevel SEM framework for assessing multilevel mediation. Psychol Methods. 2010;15:209–233. doi: 10.1037/a0020141.
    1. Hsieh H, Shannon SE. Three approaches ot qualitative content analysis. Qual Health. 2005;15:1279–1288.
    1. 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. doi: 10.1016/j.jpainsymman.2016.12.331.
    1. Sudore RL, Fried TR. Redefining the “planning” in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010;153(4):256. doi: 10.7326/0003-4819-153-4-201008170-00008.
    1. Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and quality of end-of-life care: a national study. J Am Geriatr Soc. 2007;55(2):189–194. doi: 10.1111/j.1532-5415.2007.01045.x.
    1. Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, et al. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300(14):1665. doi: 10.1001/jama.300.14.1665.

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