Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial

Lauren Whitmore, Taylor Schulte, Katrin Bovbjerg, Madison Hartstein, Jane Austin, George Luta, Lily McFarland, Scott D Rowley, Themba Nyirenda, Marquita Lewis-Thames, Annette L Stanton, Heiddis Valdimarsdottir, Kristi Graves, Christine Rini, Lauren Whitmore, Taylor Schulte, Katrin Bovbjerg, Madison Hartstein, Jane Austin, George Luta, Lily McFarland, Scott D Rowley, Themba Nyirenda, Marquita Lewis-Thames, Annette L Stanton, Heiddis Valdimarsdottir, Kristi Graves, Christine Rini

Abstract

Background: During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak, and when intervention could prevent development of persistent symptoms.

Methods: WISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention "neutral writing" task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately 4 weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention.

Discussion: The steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial.

Trial registration: Clinicaltrial.gov NCT03800758 . Registered January 11, 2019.

Keywords: Cancer survivors; Expressive writing; Hematopoietic stem cell transplant; Patient-reported outcomes; Peer support; Psychological intervention; Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow diagram

References

    1. D'Souza A, Fretham C, Lee SJ, Arora M, Brunner J, Chhabra S, et al. Current use of and trends in hematopoietic cell transplantation in the United States. Biol Blood Marrow Transplant. 2020;26(8):e177–e182.
    1. Amonoo HL, Massey CN, Freedman ME, El-Jawahri A, Vitagliano HL, Pirl WF, et al. Psychological considerations in hematopoietic stem cell transplantation. Psychosomatics. 2019;60(4):331–342. doi: 10.1016/j.psym.2019.02.004.
    1. Majhail NS. Long-term complications after hematopoietic cell transplantation. Hematol Oncol Stem Cell Ther. 2017;10(4):220–227. doi: 10.1016/j.hemonc.2017.05.009.
    1. Rueda-Lara M, Lopez-Patton MR. Psychiatric and psychosocial challenges in patients undergoing haematopoietic stem cell transplants. Int Rev Psychiatry. 2014;26(1):74–86. doi: 10.3109/09540261.2013.866075.
    1. Mosher CE, DuHamel KN, Rini C, Corner G, Lam J, Redd WH. Quality of life concerns and depression among hematopoietic stem cell transplant survivors. Support Care Cancer. 2011;19(9):1357–1365. doi: 10.1007/s00520-010-0958-y.
    1. Norkin M, Hsu JW, Wingard JR. Quality of life, social challenges, and psychosocial support for long-term survivors after allogeneic hematopoietic stem-cell transplantation. Semin Hematol. 2012;49(1):104–109. doi: 10.1053/j.seminhematol.2011.10.004.
    1. Anderson KO, Giralt SA, Mendoza TR, Brown JO, Neumann JL, Mobley GM, Wang XS, Cleeland CS. Symptom burden in patients undergoing autologous stem-cell transplantation. Bone Marrow Transplant. 2007;39(12):759–766. doi: 10.1038/sj.bmt.1705664.
    1. Bevans MF, Mitchell SA, Marden S. The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT) Support Care Cancer. 2008;16(11):1243–1254. doi: 10.1007/s00520-008-0420-6.
    1. Syrjala KL, Langer SL, Abrams JR, Storer B, Sanders JE, Flowers ME, Martin PJ. Recovery and long-term function after hematopoietic cell transplantation for leukemia or lymphoma. JAMA. 2004;291(19):2335–2343. doi: 10.1001/jama.291.19.2335.
    1. Loberiza FR, et al. Association of depressive syndrome and early deaths among patients after stem-cell transplantation for malignant diseases. J Clin Oncol Off J Am Soc Clin Oncol. 2002;20(8):2118–2126. doi: 10.1200/JCO.2002.08.757.
    1. Ostuzzi G, Matcham F, Dauchy S, Barbui C, Hotopf M. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2015:CD011006. 10.1002/14651858.CD011006.pub2.
    1. Broers S, Kaptein AA, Le Cessie S, Fibbe W, Hengeveld MW. Psychological functioning and quality of life following bone marrow transplantation: a 3-year follow-up study. J Psychosom Res. 2000;48(1):11–21. doi: 10.1016/S0022-3999(99)00059-8.
    1. Hjermstad MJ, Evensen SA, Kvaløy SO, Fayers PM, Kaasa S. Health-related quality of life 1 year after allogeneic or autologous stem-cell transplantation: a prospective study. J Clin Oncol Off J Am Soc Clin Oncol. 1999;17(2):706–718. doi: 10.1200/JCO.1999.17.2.706.
    1. El-Jawahri A, et al. Effect of inpatient palliative care on quality of life 2 weeks after hematopoietic stem cell transplantation: a randomized clinical trial. JAMA. 2016;316(20):2094–2103. doi: 10.1001/jama.2016.16786.
    1. Prieto JM, Atala J, Blanch J, Carreras E, Rovira M, Cirera E, Espinal A, Gasto C. Role of depression as a predictor of mortality among cancer patients after stem-cell transplantation. J Clin Oncol Off J Am Soc Clin Oncol. 2005;23(25):6063–6071. doi: 10.1200/JCO.2005.05.751.
    1. Mosher CE, Redd WH, Rini CM, Burkhalter JE, DuHamel KN. Physical, psychological, and social sequelae following hematopoietic stem cell transplantation: a review of the literature. Psychooncology. 2009;18(2):113–127. doi: 10.1002/pon.1399.
    1. Wong FL, Francisco L, Togawa K, Bosworth A, Gonzales M, Hanby C, Sabado M, Grant M, Forman SJ, Bhatia S. Long-term recovery after hematopoietic cell transplantation: predictors of quality-of-life concerns. Blood. 2010;115(12):2508–2519. doi: 10.1182/blood-2009-06-225631.
    1. Devins GM, Mah K, Messner HA, Xenocostas A, Gauvin L, Lipton JH. Quality of life trajectories during the first year following hematopoietic cell transplantation: an inception cohort study. Support Care Cancer. 2018;26(7):2379–2386. doi: 10.1007/s00520-018-4059-7.
    1. Rini C, Austin J, Wu LM, Winkel G, Valdimarsdottir H, Stanton AL, Isola L, Rowley S, Redd WH. Harnessing benefits of helping others: a randomized controlled trial testing expressive helping to address survivorship problems after hematopoietic stem cell transplant. Health Psychol. 2014;33(12):1541–1551. doi: 10.1037/hea0000024.
    1. Pennebaker JW, Chung CK. Expressive writing and its links to mental and physical health. In: Friedman HS, editor. Oxford handbook of health psychology. New York: Oxford University Press; 2011.
    1. Smyth JM. Written emotional expression: effect sizes, outcome types, and moderating variables. J Consult Clin Psychol. 1998;66(1):174–184. doi: 10.1037/0022-006X.66.1.174.
    1. Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006;132(6):823–865. doi: 10.1037/0033-2909.132.6.823.
    1. Frisina PG, Borod JC, Lepore SJ. A meta-analysis of the effects of written emotional disclosure on the health outcomes of clinical populations. J Nerv Ment Dis. 2004;192(9):629–634. doi: 10.1097/01.nmd.0000138317.30764.63.
    1. Oh PJ, Kim SH. The effects of expressive writing interventions for patients with cancer: a meta-analysis. Oncol Nurs Forum. 2016;43(4):468–479. doi: 10.1188/16.ONF.468-479.
    1. Zhou C, Wu Y, An S, Li X. Effect of expressive writing intervention on health outcomes in breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2015;10(7):e0131802. doi: 10.1371/journal.pone.0131802.
    1. Zachariae R, O'Toole MS. The effect of expressive writing intervention on psychological and physical health outcomes in cancer patients--a systematic review and meta-analysis. Psychooncology. 2015;24(11):1349–1359. doi: 10.1002/pon.3802.
    1. Stanton AL, Danoff-Burg S, Sworowski LA, Collins CA, Branstetter AD, Rodriguez-Hanley A, Kirk SB, Austenfeld JL. Randomized, controlled trial of written emotional expression and benefit finding in breast cancer patients. J Clin Oncol. 2002;20(20):4160–4168. doi: 10.1200/JCO.2002.08.521.
    1. Merz EL, Fox RS, Malcarne VL. Expressive writing interventions in cancer patients: a systematic review. Health Psychol Rev. 2014;8(3):339–361. doi: 10.1080/17437199.2014.882007.
    1. Jensen-Johansen MB, Christensen S, Valdimarsdottir H, Zakowski S, Jensen AB, Bovbjerg DH, Zachariae R. Effects of an expressive writing intervention on cancer-related distress in Danish breast cancer survivors - results from a nationwide randomized clinical trial. Psychooncology. 2013;22(7):1492–1500. doi: 10.1002/pon.3193.
    1. Roman LA, Lindsay JK, Moore JS, Shoemaker AL. Community health workers: examining the helper therapy principle. Public Health Nurs. 1999;16(2):87–95. doi: 10.1046/j.1525-1446.1999.00087.x.
    1. Piferi RL, Lawler KA. Social support and ambulatory blood pressure: an examination of both receiving and giving. Int J Psychophysiol. 2006;62(2):328–336. doi: 10.1016/j.ijpsycho.2006.06.002.
    1. Wallston KA, McMinn M, Katahn M, Pleas J. The helper-therapy principle applied to weight management specialists. J Community Psychol. 1983;11(1):58–66. 10.1002/1520-6629(198301)11:1<58::AID-JCOP2290110106>;2-P.
    1. Heisler M, Choi H, Piette JD, Rosland A, Langa KM, Brown S. Adults with cardiovascular disease who help others: a prospective study of health outcomes. J Behav Med. 2013;36(2):199–211. doi: 10.1007/s10865-012-9414-4.
    1. Yin J, Wong R, Au S, Chung H, Lau M, Lin L, Tsang C, Lau K, Ozaki R, So W, Ko G, Luk A, Yeung R, Chan JCN. Effects of providing peer support on diabetes management in people with type 2 diabetes. Ann Fam Med. 2015;13(Suppl 1):S42–S49. doi: 10.1370/afm.1853.
    1. Brown SL, Nesse RM, Vinokur AD, Smith DM. Providing social support may be more beneficial than receiving it: results from a prospective study of mortality. Psychol Sci. 2003;14(4):320–327. doi: 10.1111/1467-9280.14461.
    1. Inagaki TK, Orehek E. On the benefits of giving social support. Curr Dir Psychol Sci. 2017;26(2):109–113. doi: 10.1177/0963721416686212.
    1. Konrath S, Brown S. The effects of giving on givers. Health and social relationships: the good, the bad, and the complicated. 2013. pp. 39–64.
    1. Riessman F. The helper therapy principle. Soc Work. 1965;10(2):27–32.
    1. Inagaki TK, Eisenberger NI. Giving support to others reduces sympathetic nervous system-related responses to stress. Psychophysiology. 2016;53(4):427–435. doi: 10.1111/psyp.12578.
    1. Lepore SJ, Revenson TA. Social constraints on disclosure and adjustment to cancer. Soc Personal Psychol Compass. 2007;1(1):313–333. doi: 10.1111/j.1751-9004.2007.00013.x.
    1. Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, VanRyn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008;23(5):561–566. doi: 10.1007/s11606-008-0520-5.
    1. Freedland KE, King AC, Ambrosius WT, Mayo-Wilson E, Mohr DC, Czajkowski SM, Thabane L, Collins LM, Rebok GW, Treweek SP, Cook TD, Edinger JD, Stoney CM, Campo RA, Young-Hyman D, Riley WT, National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. J Clin Epidemiol. 2019;110:74–81. doi: 10.1016/j.jclinepi.2019.02.011.
    1. Pennebaker JW. Writing about emotional experiences as a therapeutic process. Psychol Sci. 1997;8(3):162–166. doi: 10.1111/j.1467-9280.1997.tb00403.x.
    1. Pennebaker JW, Beall SK. Confronting a traumatic event - toward an understanding of inhibition and disease. J Abnorm Psychol. 1986;95(3):274–281. doi: 10.1037/0021-843X.95.3.274.
    1. Low CA, Stanton AL, Bower JE, Gyllenhammer L. A randomized controlled trial of emotionally expressive writing for women with metastatic breast cancer. Health Psychol. 2010;29(4):460–466. doi: 10.1037/a0020153.
    1. 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):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, et al. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000;89(7):1634–46. 10.1002/1097-0142(20001001)89:7<1634::AID-CNCR29>;2-V.
    1. Radloff LS. The CES-D scale: a self report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Hann D, Winter K, Jacobsen P. Measurement of depressive symptoms in cancer patients: evaluation of the Center for Epidemiological Studies Depression Scale (CES-D) J Psychosom Res. 1999;46(5):437–443. doi: 10.1016/S0022-3999(99)00004-5.
    1. Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, Yount SE, McGregor BA, Arena PL, Harris SD, Price AA, Carver CS. Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol. 2001;20(1):20–32. doi: 10.1037/0278-6133.20.1.20.
    1. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Horowitz M, Wilner N, Alvarez W. Impact of event scale: a measure of subjective stress. Psychosom Med. 1979;41(3):209–218. doi: 10.1097/00006842-197905000-00004.
    1. Salsman JM, Schalet BD, Andrykowski MA, Cella D. The impact of events scale: a comparison of frequency versus severity approaches to measuring cancer-specific distress. Psychooncology. 2015;24(12):1738–1745. doi: 10.1002/pon.3784.
    1. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–880. doi: 10.1007/s11136-009-9496-9.
    1. Shaw BE, Syrjala KL, Onstad LE, Chow EJ, Flowers ME, Jim H, Baker KS, Buckley S, Fairclough DL, Horowitz MM, Lee SJ. PROMIS measures can be used to assess symptoms and function in long-term hematopoietic cell transplantation survivors. Cancer. 2018;124(4):841–849. doi: 10.1002/cncr.31089.
    1. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manag. 1997;13(2):63–74. doi: 10.1016/S0885-3924(96)00274-6.
    1. Cella D, Lai JS, Stone A. Self-reported fatigue: one dimension or more? Lessons from the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F) questionnaire. Support Care Cancer. 2011;19(9):1441–1450. doi: 10.1007/s00520-010-0971-1.
    1. Butt Z, Lai JS, Rao D, Heinemann AW, Bill A, Cella D. Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale. J Psychosom Res. 2013;74(1):64–68. doi: 10.1016/j.jpsychores.2012.10.011.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Beck SL, Schwartz AL, Towsley G, Dudley W, Barsevick A. Psychometric evaluation of the Pittsburgh Sleep Quality Index in cancer patients. J Pain Symptom Manag. 2004;27(2):140–148. doi: 10.1016/j.jpainsymman.2003.12.002.
    1. Fontes F, Goncalves M, Maia S, Pereira S, Severo M, Lunet N. Reliability and validity of the Pittsburgh Sleep Quality Index in breast cancer patients. Support Care Cancer. 2017;25(10):3059–3066. doi: 10.1007/s00520-017-3713-9.
    1. Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005;106(8):2912–2919. doi: 10.1182/blood-2005-05-2004.
    1. Richards JM, Beal WE, Seagal JD, Pennebaker JW. Effects of disclosure of traumatic events on illness behavior among psychiatric prison inmates. J Abnorm Psychol. 2000;109(1):156–160. doi: 10.1037/0021-843X.109.1.156.
    1. Castro-Schilo L, Grimm K. Using residualized change versus difference scores for longitudinal research. J Soc Pers Relat. 2018;35(1):32–58. doi: 10.1177/0265407517718387.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons; 1987.

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