Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol

Michael A Hoyt, Ashley Wei-Ting Wang, Sean J Ryan, Elizabeth C Breen, Jennifer S Cheavens, Christian J Nelson, Michael A Hoyt, Ashley Wei-Ting Wang, Sean J Ryan, Elizabeth C Breen, Jennifer S Cheavens, Christian J Nelson

Abstract

Background: Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment. These include psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones). However, few targeted interventions exist to assist young survivors in renegotiating life goals and regulating cancer-related emotions, and none focus on reducing the burden of morbidity via biobehavioral mechanisms. This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary impact of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.

Methods: Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over 8 weeks. In addition to indicators of intervention feasibility, we will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), and 12 weeks after (T2) intervention. Additionally, identified biomarkers will be measured at baseline and at T2.

Discussion: GET may have the potential to improve self-regulation across biobehavioral domains, improve overall cancer adjustment, and address the need for targeted supportive care interventions for young adult cancer survivors.

Trial registration: Clinicaltrials.gov, NCT04150848. Registered on 28 October 2019.

Keywords: Biobehavioral; Cancer survivorship; Goal; Intervention; Testicular cancer; Young adult.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study schematic. GET Goal-Focused Emotion-Regulation Therapy, ISP Individual Supportive Psychotherapy, R randomization, Sn session number, T0 baseline, T1 post Intervention, T2 12-week follow-up

References

    1. NCI/LYAA (National Cancer Institute and the Livestrong Young Adult Alliance). Closing the gap. Bethesda: research and care imperatives for adolescents and young adults with cancer (NIH Publication No. 06–6067). Bethesda; 2006.
    1. National Cancer Institute (NCI). Cancer stat facts: testicular cancer. Accessed 16 Feb 2019.
    1. Smith AB, Butow P, Olver I, Luckett T, Grimison P, Tonor GC, et al. The prevalence, severity, and correlates of psychological distress and impaired health-related quality of life following treatment for testicular cancer: a survivorship study. J Cancer Survivorship. 2016;10:223–233. doi: 10.1007/s11764-015-0468-5.
    1. Smith AB, Rutherford C, Butow P, Olver I, Luckett T, Grimison P, et al. A systematic review of quantitative observational studies investigation psychological distress in testicular cancer survivors. Psycho Oncol. 2018;27:1129–1137. doi: 10.1002/pon.4596.
    1. Skoogh J, Steineck G, Cavallin-Ståhl E, Wilderäng U, Håkansson UK, Johansson B, et al. Feelings of loss and uneasiness or shame after removal of a testicle by orchiectomy: a population-based long-term follow-up of testicular cancer survivors. Intl J Androl. 2011;34:183–192. doi: 10.1111/j.1365-2605.2010.01073.x.
    1. Brydøy M, Oldenburg J, Klepp O, Bremnes RM, Wist EA, Wentzel-Larsen T, et al. Observational study of prevalence of long-term Raynaud-like phenomena and neurological side effects in testicular cancer survivors. J Natl Cancer Inst. 2009;101:1682–1695. doi: 10.1093/jnci/djp413.
    1. Hartmann JT, Albrecht C, Schmoll HJ, Kuvzyk MA, Kollmannsberger C, Bokemeyer C. Long-term effects on sexual function and fertility after treatment of testicular cancer. Br J Cancer. 1999;80:801–807. doi: 10.1038/sj.bjc.6690424.
    1. Smith ZL, Werntz RP, Eggener SE. Testicular cancer: epidemiology, diagnosis, and management. Med Clinics North Amer. 2018;102:251–264. doi: 10.1016/j.mcna.2017.10.003.
    1. Rossen PB, Pedersen AF, Zachariae R, von der Maase H. Health-related quality of life in long-term survivors of testicular cancer. J Clin Oncol. 2009;27:5993–5999. doi: 10.1200/JCO.2008.19.6931.
    1. Jonker-Pool G, van de Wiel HB, Hoekstra HJ, Sleijfer DT, van Driel MF, van Basten JP, Schraffordt Koops HS. Sexual functioning after treatment for testicular cancer—review and meta-analysis of 36 empirical studies between 1975–2000. Arch Sex Beh. 2001;30:55–74. doi: 10.1023/A:1026468707362.
    1. Kim C, McGlynn KA, McCorkle R, Li YH, Erickson RL, Ma SG, et al. Sexual functioning among testicular cancer survivors: a case–control study in the U.S. J Psychosom Res. 2012;73:68–73. doi: 10.1016/j.jpsychores.2012.02.011.
    1. Fleer J, Hoekstra HJ, Sleijfer DT, Hoekstra-Weebers JEHM. Quality of life of survivors of testicular germ cell cancer: a review of the literature. Sup Care Cancer. 2004;12:476–486. doi: 10.1007/s00520-004-0646-x.
    1. Jonker-Pool G, Hoekstra HJ, van Imhoff GW, Sonneveld DJA, Sleijfer DT, van Driel MF, et al. Male sexuality after cancer treatment—needs for information and support: testicular cancer compared to malignant lymphoma. Pat Edu Counsel. 2004;52:143–150. doi: 10.1016/S0738-3991(03)00025-9.
    1. Bender JL, Wiljer D, To MJ. Bedard PL, Chung P, Jewett MAS, et al. Testicular cancer survivors’ supportive care needs and use of online support: a cross-sectional survey. Sup Care Cancer. 2012;20:2737–2746. doi: 10.1007/s00520-012-1395-x.
    1. Smith A, King M, Butow P, Luckett T, Grimison P, Toner GC, et al. The prevalence and correlates of supportive care needs in testicular cancer survivors: a cross-sectional survey. Psycho-Oncology. 2013;22:2557–2564. doi: 10.1002/pon.3323.
    1. Ryan S, Hoyt MA. Adult self-image and well-being after testicular cancer: the role of agency and meaning. Psychol Health. 2018;33:1049–1061. doi: 10.1080/08870446.2018.1456659.
    1. Teckle P, Peacock S, McBride ML, Bentley C, Goddard K, Rogers P. Long-term effects of cancer on earnings of childhood, adolescent, and young adult cancer survivors—a population-based study from British Columbia, Canada. BMC Health Ser Res. 2018;18:826. doi: 10.1186/s12913-018-3617-5.
    1. Walker E, Martins A, Aldiss S, Gibson F, Taylor RM. Psychosocial interventions for adolescents and young adults diagnosed with cancer during adolescence: a critical review. J Adol Young Adult Oncol. 2016;5:310–321. doi: 10.1089/jayao.2016.0025.
    1. Wrosch C, Scheier MF, Miller GE, Schulz R, Carver CS. Adaptive self-regulation of unattainable goals: goal disengagement, goal reengagement, and subjective well-being. Personal Soc Psychol Bull. 2003;29:1494–1508. doi: 10.1177/0146167203256921.
    1. Salsman JM, Garcia SF, Yanez B, Sanford SD, Snyder MA, Voctorson D. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014;120:2247–2254. doi: 10.1002/cncr.28739.
    1. Heckhausen J, Wrosch C, Schulz R. A motivational theory of lifespan development. Psychol Rev. 2010;117:32–60. doi: 10.1037/a0017668.
    1. Hullman SE, Robb SL, Rand KL. Life goals in patients with cancer: a systematic review of the literature. Psycho-Oncology. 2016;254:387–399. doi: 10.1002/pon.3852.
    1. Thompson E, Stanton AL, Bower JE. Situational and dispositional goal adjustment in the context of metastatic breast cancer. J Pers. 2013;81:441–451. doi: 10.1111/jopy.12025.
    1. Hayden MD, Stanton AL, Ganz PA, Bower JE. Goal disturbance in early-stage breast cancer survivors. J Psychosoc Oncol. 2019; In press.
    1. Arnett JJ. New horizons in emerging and young adulthood. In: Booth A, Crouter N, editors. Early adulthood in a family context. New York: Springer; 2012. pp. 234–244.
    1. Eiser C, Aura K. Psychological support. In: Bleyer A, Barr R, Ries L, Ferrari, editors. Cancer in adolescents and young adults. New York: Springer; 2017. pp. 365–373.
    1. Shama W, Lucchetta S. Psychosocial issues of the adolescent cancer patient and the development of the teenage outreach program (TOP) J Psychosoc Oncol. 2007;25:99–112. doi: 10.1300/J077v25n03_06.
    1. Hoyt MA, Cano SJ, Saigal CS, Stanton AL. Health-related quality of life in young men with testicular cancer: validation of the Cancer Assessment for Young Adults. J Cancer Survivorship Res Prac. 2013;7:630–640. doi: 10.1007/s11764-013-0302-x.
    1. Hoyt MA, Stanton AL, Bower JE, Thomas KS, Litwin MS, Breen EC, Irwin MR. Inflammatory biomarkers and emotional approach coping in men with prostate cancer. Brain, Behav. Immun. 2013;32:173–179.
    1. Hoyt MA, Stanton AL, Irwin MR, Thomas KS. Cancer-related masculine threat, emotional approach coping, and physical functioning following treatment for prostate cancer. Health Psychol. 2013;32:66–74. doi: 10.1037/a0030020.
    1. Hoyt MA. Gender role conflict and emotional approach coping in men with cancer. Psychol Health. 2009;24:1–15. doi: 10.1080/08870440802311330.
    1. Lutgendorf SK, Sood AK. Biobehavioral factors and cancer progression: physiological pathways and mechanisms. Psychosom Med. 2011;73:724–730. doi: 10.1097/PSY.0b013e318235be76.
    1. Miller AH, Ancoli-Israel S, Bower JE, Capuron L, Irwin MR. Neuroendocrine-immune mechanisms of behavioral comorbidities in patients with cancer. J Clin Oncol. 2008;26:971–982. doi: 10.1200/JCO.2007.10.7805.
    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;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Stanton AL, Williamson TJ, Harris LN. Cancer. In: Revenson TA, Gurung RAR, editors. Handbook of health psychology. New York: Routledge; 2019. pp. 396–409.
    1. Lovejoy TI, Fowler D. Designing and evaluating health psychology interventions. In: Revenson TA, Gurung RAR, editors. Handbook of health psychology. New York: Routledge; 2019. pp. 41–55.
    1. Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, et al. From ideas to efficacy: the ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015;34:971–982. doi: 10.1037/hea0000161.
    1. Nicolson NA. Measurement of cortisol. In: Luecken LJ, Gallo LC, editors. Handbook of physiological research methods in health psychology. Thousand Oaks: Sage; 2008. pp. 37–74.
    1. Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma. Cancer. 1998;82:1904–1908. doi: 10.1002/(SICI)1097-0142(19980515)82:10<1904::AID-CNCR13>;2-X.
    1. O'Conner MF, Bower JE, Cho HJ, Creswell JD, Dimitrov S, Hamby ME, Hoyt MA, et al. To assess, to control, to exclude: effects of biobehavioral factors on circulating inflammatory markers. Brain Beh Immun. 2009;23:887–897. doi: 10.1016/j.bbi.2009.04.005.
    1. Hoyt MA, Gamarel KE, Saigal CS, Stanton AL. Goal navigation, approach-oriented coping, and cancer adjustment in young men with testicular cancer. Ann Behav Med. 2016;50:572–581. doi: 10.1007/s12160-016-9785-9.
    1. Hoyt MA, Nelson C, Darabos K, Marin-Chollom A, Stanton AL. Mechanisms of navigating goals after testicular cancer: meaning and emotion-regulation. Psycho-Oncology. 2017;26:747–754. doi: 10.1002/pon.4068.
    1. Cheavens JS, Feldman DB, Gum A, Michael ST, Snyder CR. Hope therapy in a community sample: a pilot investigation. Soc Indic Res. 2016;77:61–78. doi: 10.1007/s11205-005-5553-0.
    1. Thornton LM, Cheavens JS, Heitzman CA, Dorfman CS, Wu SM, Andersen BL. Test of mindfulness and hope components in a psychological intervention for women with cancer recurrence. J Consul Clin Psychol. 2014;82:1087–1100. doi: 10.1037/a0036959.
    1. Payne DK, Lundberg JC, Brennan MF, Holland JC. A psychosocial intervention for patients with soft tissue sarcoma. Psycho Oncol. 1997;6:65–71. doi: 10.1002/(SICI)1099-1611(199703)6:1<65::AID-PON236>;2-2.
    1. Rogers C. Client-centered therapy: its current practice, implications and theory. London: Constable; 1951.
    1. Rogers C. A way of being. Boston: Houghton Mifflin; 1980.
    1. Block S. An introduction to the psychotherapies. Oxford: Oxford University Press; 1996.
    1. NCCN N.C.C.N. Distress Management Clinical Practice Guidelines. J Natl Comprehensive Cancer Net. 2003;1:344–374. doi: 10.6004/jnccn.2003.0031.
    1. Grassi L, Sabato S, Rossi E, Marmai L, Biancosino B. Affective syndromes and their screening in cancer patients with early and stable disease: Italian ICD-10 data and performance of the Distress Thermometer from the Southern European Psycho-Oncology Study (SEPOS) J Affective Dis. 2009;114:193–199. doi: 10.1016/j.jad.2008.07.016.
    1. Jacobsen PB, Donavan KA, Trask PC, Fleischman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer. 2005;103:1494–1502. doi: 10.1002/cncr.20940.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hermert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27:363–370. doi: 10.1017/S0033291796004382.
    1. Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003;85:348–362. doi: 10.1037/0022-3514.85.2.348.
    1. Snyder CR, Harris C, Anderson JR, Holleran SA, Irving LM, Sigmon ST, et al. The will and the ways: development and validation of an individual-differences measure of hope. J Pers Soc Psychol. 1991;60:570–585. doi: 10.1037/0022-3514.60.4.570.
    1. Sampson JP, Peterson GW, Lenz JG, Reardon RC, Saunders DE. Career Thoughts Inventory: professional manual. Odessa: Psychological Assessment Resources.; 1996.
    1. Strahler J, Skoluda N, Kappert MB, Nater UM. Simultaneous measurement of salivary cortisol and alpha-amylase: application and recommendations. Neurosci Biobehav Rev. 2017;83:657–677. doi: 10.1016/j.neubiorev.2017.08.015.
    1. Ali N, Nater UM. Salivary alpha-amylase as a biomarker of stress in behavioral medicine. Intl J Behav Med. In press.
    1. Braun V, Clarke C. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101. doi: 10.1191/1478088706qp063oa.
    1. Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psych. 2010;10:113. doi: 10.1186/1471-244X-10-113.
    1. White A, McKee M, Richardson N, Visser R, Madsen SA, Sousa BC, et al. Europe’s men need their own health strategy. Br Med J. 2011;343:d7397. doi: 10.1136/bmj.d7397.
    1. Galdas P, Darwin Z, Kidd L, Blickem C, McPherson K, Hunt K, et al. The accessibility and acceptability of self-management support interventions for men with long term conditions: a systematic review and meta-synthesis of qualitative studies. BMC Pub Health. 2014;14:1230. doi: 10.1186/1471-2458-14-1230.
    1. Barrett LF, Mesquita B, Ochsner KN, Gross JJ. The experience of emotion. Annual Rev Psychol. 2007;58:373–403. doi: 10.1146/annurev.psych.58.110405.085709.
    1. Ochsner KN, Gross JJ. The cognitive control of emotion. Trends Cog Sci. 2005;9:242–249. doi: 10.1016/j.tics.2005.03.010.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2:64. doi: 10.1186/s40814-016-0105-8.
    1. Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016;2:25. doi: 10.1186/s40814-016-0065-z.
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10:307–312. doi: 10.1111/j..2002.384.doc.x.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅