Annals of Behavioral Medicine

, Volume 32, Issue 2, pp 104–110 | Cite as

Efficacy of psychosocial interventions in cancer care: Evidence is weaker than it first looks

  • James C. Coyne
  • Stephen J. Lepore
  • Steven C. Palmer
Article

Abstract

With increasing sophistication, successive reviews find weaker evidence for the efficacy of psychosocial interventions to reduce distress among cancer patients. However, these appraisals may still be overly positive because of reviewers’ uncritical acceptance of flaws in the design, analysis, and reporting of the results of such trials. Using randomized trials from high-impact journals, we show confirmatory bias, selective reporting of the most favorable of multiple outcome measures, suppressing of null results in subsequent citations of trials, and dropping of data for patients least likely to benefit from intervention. The conclusion that typical cancer patients do not benefit from interventions to reduce distress is strengthened when these endemic problems with the literature are taken into account. Required registering of the details of clinical trials and adherence to CONSORT reduces but does not eliminate bias in the literature.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. (1).
    Altman DG: The scandal of poor medical research: We need less research, better research, and research done for the right reasons.British Medical Journal. 1994,308:283–284.PubMedGoogle Scholar
  2. (2).
    Lepore SJ, Coyne JC: Psychological interventions and distress in cancer patients: A review of reviews.Annals of Behavioral Medicine. 2006,32:85–92. [this issue]PubMedCrossRefGoogle Scholar
  3. (3).
    Edelman S, Craig A, Kidman AD: Group interventions with cancer patients: Efficacy of psychoeducational versus supportive groups.Journal of Psychosocial Oncology. 2000,18:67–85.CrossRefGoogle Scholar
  4. (4).
    Butler LD, Koopman C, Cordova MJ, et al.: Psychological distress and pain significantly increase before death in metastatic breast cancer patients.Psychosomatic Medicine. 2003,65:416–426.PubMedCrossRefGoogle Scholar
  5. (5).
    Classen C, Butler LD, Koopman C, et al.: Supportive-expressive group therapy and distress in patients with metastatic breast cancer—A randomized clinical intervention trial.Archives of General Psychiatry. 2001,58:494–501.PubMedCrossRefGoogle Scholar
  6. (6).
    Antoni MH, Lehman JM, Kilbourn KM, et al.: Cognitivebehavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer.Health Psychology. 2001,20:20–32.PubMedCrossRefGoogle Scholar
  7. (7).
    Zakowski SG, Ramati A, Morton C, et al.: Written emotional disclosure buffers the effects of social constraints on distress among cancer patients.Health Psychology. 2004,23:555–563.PubMedCrossRefGoogle Scholar
  8. (8).
    Altman DG, Schulz KF, Moher D: The revised CONSORT statement for reporting randomized trials: Explanation and elaboration.Annals of Internal Medicine. 2001,134:663–694.PubMedGoogle Scholar
  9. (9).
    Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.Journal of the American Medical Association. 1995,273:408–412.PubMedCrossRefGoogle Scholar
  10. (10).
    Begg C, Cho M, Eastwood S, et al.: Improving the quality of reporting of randomized controlled trials: The CONSORT statement.Journal of the American Medical Association. 1996,276:637–639.PubMedCrossRefGoogle Scholar
  11. (11).
    Shapiro SH, Weijer C, Freedman B: Reporting the study populations of clinical trials: Clear transmission or static on the line?Journal of Clinical Epidemiology. 2000,53:973–979.PubMedCrossRefGoogle Scholar
  12. (12).
    Manne SL, Ostroff JS, Winkel G, et al.: Couple-focused group intervention for women with early stage breast cancer.Journal of Consulting and Clinical Psychology. 2005,73:634–646.PubMedCrossRefGoogle Scholar
  13. (13).
    Cook JM, Palmer SC, Coyne JC: Reporting of randomized clinical trials in journal of consulting and clinical psychology 1992 and 2002: Before CONSORT and beyond. Manuscript submitted for publication.Google Scholar
  14. (14).
    Cohen J:Statistical Power Analysis for the Behavioral Sciences (2nd Ed.). Hillsdale, NJ: Lawrence Erlbaum Associates, Inc., 1988.Google Scholar
  15. (15).
    Spiegel D, Giese-Davis J: Depression and cancer: Mechanisms and disease progression.Biological Psychiatry. 2003,54:269–282.PubMedCrossRefGoogle Scholar
  16. (16).
    Edwards AGK, Hailey S, Maxwell M: Psychological interventions for women with metastatic breast cancer (Cochrane Review).The Cochrane Library, Issue 3. Chichester, UK: Wiley, 2005.Google Scholar
  17. (17).
    Antoni MH, Carver CS: More may not be better in psychosocial interventions for cancer patients—Reply to Coyne and Kagee.Health Psychology. 2001,20:458–459.CrossRefGoogle Scholar
  18. (18).
    Giese-Davis J, Koopman, C, Butler LD, et al.: Change in emotion-regulation strategy for women with metastatic breast cancer following supportive-expressive group therapyJournal of Consulting and Clinical Psychology. 2002,70:916–925.PubMedCrossRefGoogle Scholar
  19. (19).
    Penedo FJ, Dahn JR, Molton I, et al.: Cognitive-behavioral stress management improves stress-management skills and quality of life in men recovering from treatment of prostate carcinoma.Cancer. 2004,100:192–200.PubMedCrossRefGoogle Scholar
  20. (20).
    Laperriere A, Ironson, GH, Antoni, MH, et al.: Decreased depression up to one year following CBSM plus intervention in depressed women with AIDS: The smart/EST women’s projects.Journal of Health Psychology. 2005,10:223–231.PubMedCrossRefGoogle Scholar
  21. (21).
    de Moor C, Sterner J, Hall M, et al.: A pilot study of the effects of expressive writing on psychological and behavioral adjustment in patients enrolled in a Phase II trial of vaccine therapy for metastatic renal cell carcinoma.Health Psychology. 2002,21:615–619.PubMedCrossRefGoogle Scholar
  22. (22).
    Rosenberg HJ, Rosenberg SD, Ernstoff MS, et al.: Expressive disclosure and health outcomes in a prostate cancer population.International Journal of Psychiatry in Medicine. 2002,32:37–53.PubMedCrossRefGoogle Scholar
  23. (23).
    Stanton AL, Danoff-Burg S, Sworowski LA, et al.: Randomized, controlled trial of written emotional expression and benefit finding in breast cancer patients.Journal of Clinical Oncology. 2002,20:4160–4168.PubMedCrossRefGoogle Scholar
  24. (24).
    Walker BL, Nail LM, Croyle RT: Does emotional expression make a difference in reactions to breast cancer?Oncology Nursing Forum. 1999,26:1025–1032.PubMedGoogle Scholar
  25. (25).
    Frisina PG, Borod J, Lepore SJ: A meta-analysis of the effects of written emotional disclosure on health outcomes of clinical populations.Journal of Nervous and Mental Disease. 2004,192:629–634.PubMedCrossRefGoogle Scholar
  26. (26).
    Mills JL: Data torturing.New England Journal of Medicine. 1993,329:1196–1199.PubMedCrossRefGoogle Scholar
  27. (27).
    Schulz KF, Grimes DA: Epidemiology 4—Multiplicity in randomised trials I: Endpoints and treatmentsLance. 2005,365:1591–1595.CrossRefGoogle Scholar
  28. (28).
    Chan AW, Hrobjartsson A, Haahr, MT, Gotzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials—Comparison of protocols to published articles.Journal of the American Medical Association. 2004,291:2457–2465.PubMedCrossRefGoogle Scholar
  29. (29).
    Dickersin K, Rennie D: Registering clinical trialsJournal of the American Medical Association. 2003,290:516–523.PubMedCrossRefGoogle Scholar
  30. (30).
    Pocock SJ: Clinical trials with multiple outcomes: A statistical perspective on their design, analysis, and interpretation.Controlled Clinical Trials. 1997,18:530–545.PubMedCrossRefGoogle Scholar
  31. (31).
    Yusuf S, Wittes J, Probstfield J, Tyroler HA: Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical-trials.Journal of the American Medical Association. 1991,266:93–98.PubMedCrossRefGoogle Scholar
  32. (32).
    Assmann SF, Pocock SJ, Enos LE, Kasten LE: Subgroup analysis and other (mis)uses of baseline data in clinical trials.Lancet. 2000,355:1064–1069.PubMedCrossRefGoogle Scholar
  33. (33).
    Senn S, Harrell F: On wisdom after the event.Journal of Clinical Epidemiology. 1997,50:749–751.PubMedCrossRefGoogle Scholar
  34. (34).
    Brooks ST, Whitely E, Egger M: Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test.Journal of Clinical Epidemiology. 2004,57:229–236.CrossRefGoogle Scholar
  35. (35).
    Lees-Haley P, Price JR, Williams CW, Betz BP: Use of the impact of events scale in the assessment of emotional distress and PTSD may produce misleading results.Journal of Forensic Neurospychology. 2001,2:45–52.CrossRefGoogle Scholar
  36. (36).
    Goodwin PJ, Leszcz M, Ennis M, et al.: The effect of group psychosocial support on survival in metastatic breast cancer.New England Journal of Medicine. 2001,345:1719–1726.PubMedCrossRefGoogle Scholar
  37. (37).
    McNair DM, Lorr M, Droppleman LF:EITS Manual for the Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service, 1971.Google Scholar
  38. (38).
    Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB: Analysis of clinical trials by treatment actually received: Is it really an option?Statistics in Medicine. 1991,10:1595–1605.PubMedCrossRefGoogle Scholar
  39. (39).
    Peduzzi P, Henderson W, Hartigan P, Lavori P: Analysis of randomized controlled trials.Epidemiologic Reviews. 2002,24:26–38.PubMedCrossRefGoogle Scholar
  40. (40).
    Spiegel D, Bloom JR, Yalom I: Group support for patients with metastatic cancer.Archives of General Psychiatry. 1981,38:527–533.PubMedGoogle Scholar
  41. (41).
    Ross L, Thomsen BL, Boesen EH, Johansen C: In a randomized controlled trial, missing data led to biased results regarding anxiety.Journal of Clinical Epidemiology. 2004,57:1131–1137.PubMedCrossRefGoogle Scholar
  42. (42).
    Bordeleau L, Szalai JP, Ennis M, et al.: Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: Overall effects of the intervention and an exploration of missing data.Journal of Clinical Oncology. 2003,21:1944–1951.PubMedCrossRefGoogle Scholar
  43. (43).
    Altman DG: Comparability of randomized groups.Statistician. 1985,34:125–136.CrossRefGoogle Scholar
  44. (44).
    Sheard T, Maguire P: The effect of psychological interventions on anxiety and depression in cancer patients: Results of two meta-analyses.British Journal of Cancer. 1999,80:1770–1780.PubMedCrossRefGoogle Scholar
  45. (45).
    Nezu AM, Nezu CM, Felgoise SH, McClure KS, Houts PS: Project Genesis: Assessing the efficacy of problem-solving therapy for distressed adult cancer patients.Journal of Consulting and Clinical Psychology. 2003,71:1036–1048.PubMedCrossRefGoogle Scholar
  46. (46).
    Maunsell E, Brisson J, Deschenes L, Frasure-Smith N: Randomized trial of a psychologic distress screening program after breast cancer: Effects on quality of life.Journal of Clinical Oncology. 1996,14:2747–2755.PubMedGoogle Scholar
  47. (47).
    Moynihan C, Bliss JM, Davidson J, Burchell L, Horwich A: Evaluation of adjuvant psychological therapy in patients with testicular cancer: Randomised controlled trial.British Medical Journal. 1998,316:429–435.PubMedGoogle Scholar
  48. (48).
    Sollner W, Maislinger S, Konig A, Devries A, Lukas P: Providing psychosocial support for breast cancer patients based on screening for distress within a consultation-liaison service.Psycho- Oncology. 2004,13:893–897.PubMedCrossRefGoogle Scholar
  49. (49).
    Gray RE, Fitch M, Davis C, Phillips C: Interviews with men with prostate cancer about their self-help group experience.Journal of Palliative Care. 1997,13:15–21.PubMedGoogle Scholar
  50. (50).
    Moore KN, Estey A: The early post-operative concerns of men after radical prostatectomy.Journal of Advanced Nursing. 1999,29:1121–1129.PubMedCrossRefGoogle Scholar
  51. (51).
    Shapiro PJ, Coyne JC, Kruus LK, Palmer SC: Interest in services among prostate cancer patients receiving androgen deprivation therapy.Psycho-Oncology. 2004,13:512–525.PubMedCrossRefGoogle Scholar
  52. (52).
    Wong F, et al.: Men with prostate cancer: Influence of psychological factors on informational needs and decision making.Journal of Psychosomatic Research. 2000,49:13–19.PubMedCrossRefGoogle Scholar

Copyright information

© The Society of Behavioral Medicine 2006

Authors and Affiliations

  • James C. Coyne
    • 1
  • Stephen J. Lepore
    • 2
  • Steven C. Palmer
    • 3
  1. 1.Abramson Cancer Center of the University of PennsylvaniaUSA
  2. 2.Temple UniversityUSA
  3. 3.Abramson Cancer Center of the University of PennsylvaniaUSA

Personalised recommendations