Supportive Care in Cancer

, Volume 15, Issue 7, pp 885–890 | Cite as

Phase I participants’ views of quality of life and trial participation burdens

  • Marlene Zichi Cohen
  • Jacquelyn Slomka
  • Rebecca D. Pentz
  • Anne L. Flamm
  • David Gold
  • Roy S. Herbst
  • James L. Abbruzzese
Original Article

Abstract

Purpose

Participants’ perception of quality of life (QOL) and respondent burden have significant implications for investigators’ ethical responsibilities to their subjects in phase I cancer trials. To address these responsibilities, analysis was conducted on participants’ views of their experiences of a phase I trial, including the associated burdens and what constitutes QOL.

Patients and methods

One hundred potential participants of the endostatin trial were surveyed. Sixteen of the 18 trial participants were interviewed extensively about their experiences on the trial.

Results

Participants described ‘normality’ as a baseline ability to function, be productive, and be free from symptoms of disease and side effects of treatment. Reflecting the relative nontoxicity of the study drug, participants contrasted their current QOL with their negative experience of previous cancer treatments and viewed their QOL as fairly good. However, participants emphasized that indirect and procedural burdens of trial participation had a significant impact on their current QOL.

Conclusions

Candid descriptions of a trial’s practical demands, in addition to potential physical complications in a trial, could improve the quality of informed consent.

Keywords

Phase I trials Quality of life Burdens/benefits of trial participation 

References

  1. 1.
    Agrawal M, Emanuel EJ (2003) Ethics of phase I oncology studies. Reexamining the arguments and data. JAMA 290:1075–1082PubMedCrossRefGoogle Scholar
  2. 2.
    Lidz CW, Appelbaum PS (2002) The therapeutic misconception. Problems and solutions. Med Care 40(9):V55–V63 (Supplement)PubMedCrossRefGoogle Scholar
  3. 3.
    Horng S, Grady C (2003) Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 25(1):11–16PubMedCrossRefGoogle Scholar
  4. 4.
    Cohen L, de Moor C, Amato R (2001) The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase I cancer clinical trial. Cancer 91:1949–1955PubMedCrossRefGoogle Scholar
  5. 5.
    Campbell S, Whyte F (1999) The quality of life of cancer patients participating in phase I clinical trials using SEIQoL-DW. J Adv Nurs 30:335–343PubMedCrossRefGoogle Scholar
  6. 6.
    Cohen L, de Moor C, Parker PA, Amato RJ (2002) Quality of life in patients with metastatic renal cell carcinoma participating in a phase I trial of an autologous tumor-derived vaccine. Semin Urol Oncol 7:119–124Google Scholar
  7. 7.
    Melink TJ, Clark GM, Von Hoff DD (1992) The impact of phase I clinical trials on the quality of life of patients with cancer. Anti-cancer Drugs 3:572–576CrossRefGoogle Scholar
  8. 8.
    Moore S (2001) A need to try everything: patient participation in phase I trials. J Adv Nurs 33:738–747PubMedCrossRefGoogle Scholar
  9. 9.
    Cox K (2000) Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants’ experiences. Psycho-oncol 9:314–322CrossRefGoogle Scholar
  10. 10.
    Daugherty C, Ratain M, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062–1072PubMedGoogle Scholar
  11. 11.
    Hutchinson C (1998) Phase I trials in cancer patients: participants’ perceptions. Eur J Cancer Care 7:15–22CrossRefGoogle Scholar
  12. 12.
    Nurgat ZA, Craig W, Campbell NC, Bissett JD, Cassidy J, Nicolson MC (2005) Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer 92:1001–1005PubMedCrossRefGoogle Scholar
  13. 13.
    Ulrich C, Wallen G, Feister A, Grady C (2005) Respondent burden in clinical research: When are we asking too much of subjects? IRB 27(4):17–20PubMedCrossRefGoogle Scholar
  14. 14.
    Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Ayers GD, Herbst RS et al (2002) A study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol 20:3785–3791PubMedCrossRefGoogle Scholar
  15. 15.
    Cohen MZ, Kahn D, Steeves R (2000) Hermeneutic phenomenological research: a practical guide for nurse researchers. Sage, Thousand Oaks, CAGoogle Scholar
  16. 16.
    Dowling M (2004). Hermeneutics: an exploration. Nurse Res 11(4):30–39PubMedGoogle Scholar
  17. 17.
    Barritt L, Beekman T, Bleeker H, Mulderij K (1984). Analyzing phenomenological descriptions. Phenomenol + Pedagogy 2(1):1–17Google Scholar

Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Marlene Zichi Cohen
    • 1
    • 2
  • Jacquelyn Slomka
    • 4
  • Rebecca D. Pentz
    • 2
    • 3
  • Anne L. Flamm
    • 2
  • David Gold
    • 2
  • Roy S. Herbst
    • 2
  • James L. Abbruzzese
    • 2
  1. 1.Health Science Center at Houston, School of NursingThe University of TexasHoustonUSA
  2. 2.M.D. Anderson Cancer Center HoustonThe University of TexasHoustonUSA
  3. 3.Winship Cancer InstituteEmory UniversityAtlantaUSA
  4. 4.Health Science Center at Houston, School of Public HealthThe University of TexasHoustonUSA

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