Top

Published in:

01-12-2014 | Original Article

Distress among caregivers of phase I trial participants: a cross-sectional study

Authors: Elizabeth R. Kessler, Angela Moss, S. Gail Eckhardt, Mark L. Laudenslager, Kristin Kilbourn, Iris B. Mauss, Daniel W. Bowles, Sharon Hecker, Diane L. Fairclough, Jean S. Kutner

Published in: Supportive Care in Cancer | Issue 12/2014

Abstract

Purpose

The number of patients with cancer enrolling in phase I trials is expected to increase as these trials incorporate patient selection and exhibit greater efficacy in the era of targeted therapies. Despite the fact that people with advanced cancer often require a caregiver, little is known about the experience of caregivers of people enrolling in oncology phase I clinical trials. We conducted a cross-sectional study assessing the distress and emotion regulation of caregivers of phase I trial participants to inform the design of future interventions targeting the unique needs of this population.

Methods

Caregivers of oncology patients were approached at the patient’s phase I clinical trial screening visit. Caregiver participants completed a one-time survey incorporating validated instruments to comprehensively assess distress and emotion regulation. Basic demographic information about both the caregiver and patient was collected.

Results

Caregivers exhibited greater distress than population norms. Emotion regulation was also moderately impaired. Respondents identified positive aspects of caregiving despite exhibiting moderate distress.

Conclusion

Enrollment of a patient in a phase I clinical trial is a time of stress for their caregivers. This pilot study demonstrates the feasibility of engaging caregivers of phase I trial participants and the need to better support them through this component of their caregiving experience.

Given BA, Sherwood P, Given CW (2011) Support for caregivers of cancer patients: transition after active treatment. Cancer Epidemiol Biomarkers Prev 20(10):2015–2021. doi:10.1158/1055-9965.EPI-11-0611 PubMedCrossRef

Proot IM, Abu-Saad HH, ter Meulen RH, Goldsteen M, Spreeuwenberg C, Widdershoven GA (2004) The needs of terminally ill patients at home: directing one’s life, health and things related to beloved others. Palliat Med 18(1):53–61PubMedCrossRef

Hudson P (2004) Positive aspects and challenges associated with caring for a dying relative at home. Int J Palliat Nurs 10(2):58–65, discussion 65PubMedCrossRef

Stenberg U, Ruland CM, Miaskowski C (2010) Review of the literature on the effects of caring for a patient with cancer. Psychooncology 19(10):1013–1025. doi:10.1002/pon.1670 PubMedCrossRef

Spillers RL, Wellisch DK, Kim Y, Matthews BA, Baker F (2008) Family caregivers and guilt in the context of cancer care. Psychosomatics 49(6):511–519. doi:10.1176/appi.psy.49.6.511 PubMedCrossRef

Vitaliano PP, Zhang J, Young HM, Caswell LW, Scanlan JM, Echeverria D (2009) Depressed mood mediates decline in cognitive processing speed in caregivers. Gerontologist 49(1):12–22. doi:10.1093/geront/gnp004 PubMedCentralPubMedCrossRef

Sorensen S, Pinquart M, Duberstein P (2002) How effective are interventions with caregivers? An updated meta-analysis. Gerontologist 42(3):356–372PubMedCrossRef

Braun M, Mikulincer M, Rydall A, Walsh A, Rodin G (2007) Hidden morbidity in cancer: spouse caregivers. J Clin Oncol 25(30):4829–4834. doi:10.1200/JCO.2006.10.0909 PubMedCrossRef

Matthews BA (2003) Role and gender differences in cancer-related distress: a comparison of survivor and caregiver self-reports. Oncol Nurs Forum 30(3):493–499. doi:10.1188/03.ONF.493-499 PubMedCrossRef

10.

Grunfeld E, Coyle D, Whelan T, Clinch J, Reyno L, Earle CC, Willan A, Viola R, Coristine M, Janz T, Glossop R (2004) Family caregiver burden: results of a longitudinal study of breast cancer patients and their principal caregivers. CMAJ 170(12):1795–1801PubMedCentralPubMedCrossRef

11.

Lau DT, Berman R, Halpern L, Pickard AS, Schrauf R, Witt W (2010) Exploring factors that influence informal caregiving in medication management for home hospice patients. J Palliat Med 13(9):1085–1090. doi:10.1089/jpm.2010.0082 PubMedCentralPubMedCrossRef

12.

Grov EK, Eklund ML (2008) Reactions of primary caregivers of frail older people and people with cancer in the palliative phase living at home. J Adv Nurs 63(6):576–585. doi:10.1111/j.1365-2648.2008.04736.x PubMedCrossRef

13.

Northouse LL, Katapodi MC, Song L, Zhang L, Mood DW (2010) Interventions with family caregivers of cancer patients: meta-analysis of randomized trials. CA Cancer J Clin 60(5):317–339. doi:10.3322/caac.20081 PubMedCentralPubMed

14.

Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB 3rd, Castel L, Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, Slater E, Sulmasy DP, Van Echo D, Washington S, Schulman KA (2003) Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol 21(13):2589–2596. doi:10.1200/JCO.2003.10.072 PubMedCrossRef

15.

Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ (2006) Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol 24(27):4479–4484. doi:10.1200/JCO.2006.06.0269 PubMedCrossRef

16.

Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, Shoemaker D, Emanuel EJ, Grady C (2005) Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352(9):895–904. doi:10.1056/NEJMsa042220 PubMedCrossRef

17.

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(6):1001–1005. doi:10.1038/sj.bjc.6602423 PubMedCentralPubMedCrossRef

18.

Daugherty C, Ratain MJ, 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(5):1062–1072PubMed

19.

Finlay E, Lu HL, Henderson H, O’Dwyer PJ, Casarett DJ (2009) Do phase 1 patients have greater needs for palliative care compared with other cancer patients? Cancer 115(2):446–453. doi:10.1002/cncr.24025 PubMedCrossRef

20.

John OP, Gross JJ (2004) Healthy and unhealthy emotion regulation: personality processes, individual differences, and life span development. J Pers 72(6):1301–1333. doi:10.1111/j.1467-6494.2004.00298.x PubMedCrossRef

21.

Gross JJ, John OP (2003) Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol 85(2):348–362PubMedCrossRef

22.

Cohen S, Kamarck T, Mermelstein R (1983) A global measure of perceived stress. J Health Soc Behav 24(4):385–396PubMedCrossRef

23.

Cohen S, Williamson G (1988) Perceived stress in a probability sample of the United States. In: Spacapan S, Oskamp S (eds) The Social Psychology of Health. Sage Publishing, California, pp 31–67

24.

Warson D, Clark L, Tellegen A (1988) Development and validation of brief measures of positive and negative affect: The PANAS scales. J Pers Soc Psychol 54:1063–1070CrossRef

25.

Spielberger C, Gorsuch R, Lushene R (1983) Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press, Inc, California

26.

Radloff L (1977) The CES-D Scale: a self report depression scale for research in the general population. Appl Psych Meas 1:385–401CrossRef

27.

Given CW, Given B, Stommel M, Collins C, King S, Franklin S (1992) The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments. J Res Nurs Health 15(4):271–283CrossRef

28.

Grov EK, Fossa SD, Tonnessen A, Dahl AA (2006) The caregiver reaction assessment: psychometrics, and temporal stability in primary caregivers of Norwegian cancer patients in late palliative phase. Psychooncology 15(6):517–527. doi:10.1002/pon.987 PubMedCrossRef

29.

Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, Yount SE, McGregor BA, Arena PL, Harris SD, Price AA, Carver CS (2001) 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 20(1):20–32PubMedCrossRef

30.

Gratz K, Roemer L (2004) Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess 26(1):41–54CrossRef

31.

Tarlow B, Wisniewski S, Belle S, Rubert M, Ory M, Gallagher-Thompson D (2004) Positive aspects of caregiving, contributions of the REACH project to the development of a new measure for Alzheimer’s caregiving. Res Aging 26:429–453CrossRef

32.

Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF (2003) A short social support measure for patients recovering from myocardial infarction: the ENRICHD social support inventory. J Cardpulm Rehabil 23(6):398–403CrossRef

33.

Carver CS (1997) You want to measure coping but your protocol’s too long: consider the brief COPE. Int J Behav Med 4(1):92–100. doi:10.1207/s15327558ijbm0401_6 PubMedCrossRef

34.

Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 30(6):473–483PubMedCrossRef

35.

Beusterien KM, Steinwald B, Ware JE Jr (1996) Usefulness of the SF-36 health survey in measuring health outcomes in the depressed elderly. J Geriatr Psychiatry Neurol 9(1):13–21PubMedCrossRef

36.

Ware JE Jr (2000) SF-36 health survey update. Spine 25(24):3130–3139PubMedCrossRef

37.

Kim Y, Duberstein PR, Sorensen S, Larson MR (2005) Levels of depressive symptoms in spouses of people with lung cancer: effects of personality, social support, and caregiving burden. Psychosomatics 46(2):123–130. doi:10.1176/appi.psy.46.2.123 PubMedCrossRef

38.

Kim Y, Shaffer KM, Carver CS, Cannady RS (2014) Prevalence and predictors of depressive symptoms among cancer caregivers 5 years after the relative’s cancer diagnosis. J Consult Clin Psychol 82(1):1–8. doi:10.1037/a0035116 PubMedCrossRef

39.

Stenberg U, Cvancarova M, Ekstedt M, Olsson M, Ruland C (2014) Family caregivers of cancer patients: perceived burden and symptoms during the early phases of cancer treatment. Soc Work Health Care 53(3):289–309. doi:10.1080/00981389.2013.873518 PubMedCrossRef

40.

Leroy T, Christophe V, Penel N, Clisant S, Antoine P (2011) Participation in randomised clinical trials is linked to emotion regulation strategies. Contemp Clin Trials 32(1):32–35. doi:10.1016/j.cct.2010.09.003 PubMedCrossRef

41.

Pinquart M, Sorensen S (2004) Associations of caregiver stressors and uplifts with subjective well-being and depressive mood: a meta-analytic comparison. Aging Ment Health 8(5):438–449. doi:10.1080/13607860410001725036 PubMedCrossRef

42.

Mitchell AJ, Ferguson DW, Gill J, Paul J, Symonds P (2013) Depression and anxiety in long-term cancer survivors compared with spouses and healthy controls: a systematic review and meta-analysis. Lancet Oncol 14(8):721–732. doi:10.1016/S1470-2045(13)70244-4 PubMedCrossRef

43.

Boerner K, Schulz R, Horowitz A (2004) Positive aspects of caregiving and adaptation to bereavement. Psychol Aging 19(4):668–675. doi:10.1037/0882-7974.19.4.668 PubMedCrossRef

44.

Wagner CD, Tanmoy Das L, Bigatti SM, Storniolo AM (2011) Characterizing burden, caregiving benefits, and psychological distress of husbands of breast cancer patients during treatment and beyond. Cancer Nurs 34(4):E21–30. doi:10.1097/NCC.0b013e31820251f5 PubMedCrossRef

45.

Kim Y, Carver CS (2012) Recognizing the value and needs of the caregiver in oncology. Curr Opin Support Palliat Care 6(2):280–288. doi:10.1097/SPC.0b013e3283526999 PubMedCrossRef

46.

Nijboer C, Tempelaar R, Sanderman R, Triemstra M, Spruijt RJ, van den Bos GA (1998) Cancer and caregiving: the impact on the caregiver’s health. Psychooncology 7(1):3–13. doi:10.1002/(SICI)1099-1611(199801/02)7:1<3::AID-PON320>3.0.CO;2-5 PubMedCrossRef

47.

Kim Y, Baker F, Spillers RL, Wellisch DK (2006) Psychological adjustment of cancer caregivers with multiple roles. Psychooncology 15(9):795–804. doi:10.1002/pon.1013 PubMedCrossRef

48.

Wadhwa D, Burman D, Swami N, Rodin G, Lo C, Zimmermann C (2013) Quality of life and mental health in caregivers of outpatients with advanced cancer. Psychooncology 22(2):403–410. doi:10.1002/pon.2104 PubMed

49.

Covinsky KE, Goldman L, Cook EF, Oye R, Desbiens N, Reding D, Fulkerson W, Connors AF Jr, Lynn J, Phillips RS (1994) The impact of serious illness on patients’ families. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment. Jama 272(23):1839–1844PubMedCrossRef

50.

Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Kilbourn K, Spradley J, Grzywa-Cobb R, Philips S, McSweeney P, Laudenslager ML (2013) Elevated peri-transplant distress in caregivers of allogeneic blood or marrow transplant patients. Psychooncology. doi:10.1002/pon.3259 PubMedCentralPubMed

51.

Salmon P, Manzi F, Valori RM (1996) Measuring the meaning of life for patients with incurable cancer: the life evaluation questionnaire (LEQ). Eur J Cancer 32A(5):755–760PubMedCrossRef

52.

Hickey AM, Bury G, O’Boyle CA, Bradley F, O’Kelly FD, Shannon W (1996) A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS. BMJ 313(7048):29–33PubMedCentralPubMedCrossRef

53.

Girgis A, Lambert S, Johnson C, Waller A, Currow D (2013) Physical, psychosocial, relationship, and economic burden of caring for people with cancer: a review. J Oncol Pract 9(4):197–202. doi:10.1200/JOP.2012.000690 PubMedCentralPubMedCrossRef

54.

Lee KC, Chang WC, Chou WC, Su PJ, Hsieh CH, Chen JS, Tang ST (2013) Longitudinal changes and predictors of caregiving burden while providing end-of-life care for terminally ill cancer patients. J Palliat Med 16(6):632–637. doi:10.1089/jpm.2012.0499 PubMedCentralPubMedCrossRef

55.

Stoehlmacher-Williams J, Villanueva C, Foa P, Rottey S, Winquist E, Licitra L, Davidenko I, Skladowski K, Tahara M, Faivre S, Oliner K, Pan Z, Bach B, Vermorken J (2012) Safety and efficacy of panitumumab (pmab) in HPV-positive (+) and HPV-negative (−) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): analysis of the global phase III SPECTRUM trial. J Clin Oncol 30:abst 5504

56.

Kim Y, Given BA (2008) Quality of life of family caregivers of cancer survivors: across the trajectory of the illness. Cancer 112(11 Suppl):2556–2568. doi:10.1002/cncr.23449 PubMedCrossRef

57.

Williams AL, McCorkle R (2011) Cancer family caregivers during the palliative, hospice, and bereavement phases: a review of the descriptive psychosocial literature. Palliat Support Care 9(3):315–325. doi:10.1017/S1478951511000265 PubMedCrossRef

58.

Kim Y, Carver CS, Rocha-Lima C, Shaffer KM (2013) Depressive symptoms among caregivers of colorectal cancer patients during the first year since diagnosis: a longitudinal investigation. Psychooncology 22(2):362–367. doi:10.1002/pon.2100 PubMed

59.

Guada J, Land H, Han J (2011) An exploratory factor analysis of the burden assessment scale with a sample of African-American families. Community Ment Health J 47(2):233–242. doi:10.1007/s10597-010-9298-0 PubMedCrossRef

60.

Hartmann M, Bazner E, Wild B, Eisler I, Herzog W (2010) Effects of interventions involving the family in the treatment of adult patients with chronic physical diseases: a meta-analysis. Psychother Psychosom 79(3):136–148. doi:10.1159/000286958 PubMedCrossRef

61.

Martire LM, Lustig AP, Schulz R, Miller GE, Helgeson VS (2004) Is it beneficial to involve a family member? A meta-analysis of psychosocial interventions for chronic illness. Health Psychol 23(6):599–611. doi:10.1037/0278-6133.23.6.599 PubMedCrossRef

62.

Bevans M, Sternberg EM (2012) Caregiving burden, stress, and health effects among family caregivers of adult cancer patients. Jama 307(4):398–403. doi:10.1001/jama.2012.29 PubMedCentralPubMedCrossRef

Title: Distress among caregivers of phase I trial participants: a cross-sectional study
Authors: Elizabeth R. Kessler
Angela Moss
S. Gail Eckhardt
Mark L. Laudenslager
Kristin Kilbourn
Iris B. Mauss
Daniel W. Bowles
Sharon Hecker
Diane L. Fairclough
Jean S. Kutner
Publication date: 01-12-2014
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 12/2014
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-014-2380-3

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 12/2014

Psychologists’ views of inter-disciplinary psychosocial communication within the cancer care team

Risk of febrile neutropenia in patients receiving emerging chemotherapy regimens

Face-validation of quality indicators for the organization of palliative care in hospitals in Indonesia: a contribution to quality improvement

A correlational study of suicidal ideation with psychological distress, depression, and demoralization in patients with cancer

The dyadic effects of coping and resilience on psychological distress for cancer survivor couples

A comprehensive assessment protocol including patient reported outcomes, physical tests, and biological sampling in newly diagnosed patients with head and neck cancer: is it feasible?

Keynote webinar | Spotlight on antibody–drug conjugates in cancer