Clinical trial NCT01976949: Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
Official title: Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors With Clinically Significant Distress
Keywords: Cancer, social-networking intervention, cancer-related distress, internet health services, intervention delivery
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-11-06
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.

Detailed description: Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.

Eligibility criteria: Inclusion Criteria:

1. at least 18 years of age,
2. previous cancer diagnosis other than non-melanoma skin cancer,

4) fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer

Primary outcomes:
measure: Change in -Overall Psychological Functioning (OQ-45)
timeFrame: 3-month change
measure: Change in-Center for Epidemiologic Studies Depress (CES-D) scale
timeFrame: 3-month change
measure: Anxiety
timeFrame: 3-month change
Secondary outcomes:
measure: Fatigue
timeFrame: 3-month change
measure: Vigor
timeFrame: 3-month change
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Jason E Owen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen SM, Shah AC, Nezu AM, Nezu CM, Ciambrone D, Hogan J, Mor V. A problem-solving approach to stress reduction among younger women with breast carcinoma: a randomized controlled trial. Cancer. 2002 Jun 15;94(12):3089-100. doi: 10.1002/cncr.10586.
citation: Austenfeld JL, Stanton AL. Coping through emotional approach: a new look at emotion, coping, and health-related outcomes. J Pers. 2004 Dec;72(6):1335-63. doi: 10.1111/j.1467-6494.2004.00299.x.
citation: Baker F, Denniston M, Zabora J, Polland A, Dudley WN. A POMS short form for cancer patients: psychometric and structural evaluation. Psychooncology. 2002 Jul-Aug;11(4):273-81. doi: 10.1002/pon.564.
citation: Bantum EO, Owen JE. Evaluating the validity of computerized content analysis programs for identification of emotional expression in cancer narratives. Psychol Assess. 2009 Mar;21(1):79-88. doi: 10.1037/a0014643.
citation: Beskow LM, Sandler RS, Weinberger M. Research recruitment through US central cancer registries: balancing privacy and scientific issues. Am J Public Health. 2006 Nov;96(11):1920-6. doi: 10.2105/AJPH.2004.061556. Epub 2006 Mar 29.
citation: Beskow LM, Millikan RC, Sandler RS, Godley PA, Weiner BJ, Weinberger M. The effect of physician permission versus notification on research recruitment through cancer registries (United States). Cancer Causes Control. 2006 Apr;17(3):315-23. doi: 10.1007/s10552-005-0521-1.
citation: Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
citation: Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
citation: Carmack Taylor CL, Kulik J, Badr H, Smith M, Basen-Engquist K, Penedo F, Gritz ER. A social comparison theory analysis of group composition and efficacy of cancer support group programs. Soc Sci Med. 2007 Jul;65(2):262-73. doi: 10.1016/j.socscimed.2007.03.024. Epub 2007 Apr 19.
citation: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
citation: Cheshire C, Antin A. (2008). The social psychological effects of feedback on the production of Internet information pools. J Computer-Mediated Communication, 13, 705-27.
citation: Cunningham AJ, Edmonds CV, Jenkins GP, Pollack H, Lockwood GA, Warr D. A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psychooncology. 1998 Nov-Dec;7(6):508-17. doi: 10.1002/(SICI)1099-1611(199811/12)7:63.0.CO;2-7.
citation: Edwards AG, Hailey S, Maxwell M. Psychological interventions for women with metastatic breast cancer. Cochrane Database Syst Rev. 2004;(2):CD004253. doi: 10.1002/14651858.CD004253.pub2.
citation: Erdfelder E, Faul F, Buchner A. (1996). G*Power: A general power analysis program. Behavior Research, Methods, Instruments, and Computers, 28, 1-11.
citation: Fawzy FI, Fawzy NW. A structured psychoeducational intervention for cancer patients. Gen Hosp Psychiatry. 1994 May;16(3):149-92. doi: 10.1016/0163-8343(94)90098-1. No abstract available.
citation: Folkman S, Greer S. Promoting psychological well-being in the face of serious illness: when theory, research and practice inform each other. Psychooncology. 2000 Jan-Feb;9(1):11-9. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-z.
citation: Fonteyn M, Bauer-Wu S. Using qualitative evaluation in a feasibility study to improve and refine a complementary therapy intervention prior to subsequent research. Complement Ther Clin Pract. 2005 Nov;11(4):247-52. doi: 10.1016/j.ctcp.2005.05.007. Epub 2005 Nov 2.
citation: Fukui S, Kugaya A, Kamiya M, Koike M, Okamura H, Nakanishi T, Wenner M, Imoto S, Kanagawa K, Uchitomi Y. Participation in psychosocial group intervention among Japanese women with primary breast cancer and its associated factors. Psychooncology. 2001 Sep-Oct;10(5):419-27. doi: 10.1002/pon.534.
citation: Ganz PA, Kwan L, Stanton AL, Krupnick JL, Rowland JH, Meyerowitz BE, Bower JE, Belin TR. Quality of life at the end of primary treatment of breast cancer: first results from the moving beyond cancer randomized trial. J Natl Cancer Inst. 2004 Mar 3;96(5):376-87. doi: 10.1093/jnci/djh060.
citation: Graves KD. Social cognitive theory and cancer patients' quality of life: a meta-analysis of psychosocial intervention components. Health Psychol. 2003 Mar;22(2):210-9.
citation: Gustafson DH, Wise M, McTavish F, et al. (1993). Development and pilot evaluation of a computer-based support system for women with breast cancer. J Psychosoc Oncol, 11, 69-93.
citation: Gustafson DH, McTavish F, Hawkins R, Pingree S, Arora N, Mendenhall J, Simmons GE. Computer support for elderly women with breast cancer. JAMA. 1998 Oct 21;280(15):1305. doi: 10.1001/jama.280.15.1305. No abstract available.
citation: Gustafson DH, Hawkins R, Pingree S, McTavish F, Arora NK, Mendenhall J, Cella DF, Serlin RC, Apantaku FM, Stewart J, Salner A. Effect of computer support on younger women with breast cancer. J Gen Intern Med. 2001 Jul;16(7):435-45. doi: 10.1046/j.1525-1497.2001.016007435.x.
citation: Gustafson DH, Hawkins RP, Boberg EW, McTavish F, Owens B, Wise M, Berhe H, Pingree S. CHESS: 10 years of research and development in consumer health informatics for broad populations, including the underserved. Int J Med Inform. 2002 Nov 12;65(3):169-77. doi: 10.1016/s1386-5056(02)00048-5.
citation: 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 May;46(5):437-43. doi: 10.1016/s0022-3999(99)00004-5.
citation: Hartoonian N, Ormseth S, Bantum EO, Owen JE. (2008). Process and outcome evaluation of a social- networking website for health promotion. Ann Behav Med, 35s, 63.
citation: Helgeson VS, Cohen S, Schulz R, Yasko J. Group support interventions for women with breast cancer: who benefits from what? Health Psychol. 2000 Mar;19(2):107-14. doi: 10.1037//0278-6133.19.2.107.
citation: Helgeson VS, Lepore SJ, Eton DT. Moderators of the benefits of psychoeducational interventions for men with prostate cancer. Health Psychol. 2006 May;25(3):348-54. doi: 10.1037/0278-6133.25.3.348.
citation: Hewitt M, Rowland JH. Mental health service use among adult cancer survivors: analyses of the National Health Interview Survey. J Clin Oncol. 2002 Dec 1;20(23):4581-90. doi: 10.1200/JCO.2002.03.077.
citation: Hilarius DL, Kloeg PH, Detmar SB, Muller MJ, Aaronson NK. Level of agreement between patient self-report and observer ratings of health-related quality of life communication in oncology. Patient Educ Couns. 2007 Jan;65(1):95-100. doi: 10.1016/j.pec.2006.06.002. Epub 2006 Jul 26.
citation: Hsu J, Huang J, Kinsman J, Fireman B, Miller R, Selby J, Ortiz E. Use of e-Health services between 1999 and 2002: a growing digital divide. J Am Med Inform Assoc. 2005 Mar-Apr;12(2):164-71. doi: 10.1197/jamia.M1672. Epub 2004 Nov 23.
citation: Institute of Medicine (US) and National Research Council (US) National Cancer Policy Board; Hewitt M, Herdman R, Holland J, editors. Meeting Psychosocial Needs of Women with Breast Cancer. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK215943/
citation: Jacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62. doi: 10.1200/JCO.2002.08.301.
citation: Jacobsen PB, Donovan KA, Trask PC, Fleishman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer. 2005 Apr 1;103(7):1494-502. doi: 10.1002/cncr.20940.
citation: Jacobsen P, Donovan K, Swaine Z, Watson I. (2006). Management of anxiety and depression in adult cancer patients: Toward an evidence-based approach. In Oncology: An evidence-based approach. A. Chang, P. Ganz, D. Hayes, T. Kinsella, H. Pass, J. Schiller, R. Stone, V. Strecher (Eds.). New York: Springer-Verlag, p. 1552-1579.
citation: Kwekkeboom KL. Outcome expectancy and success with cognitive-behavioral interventions: the case of guided imagery. Oncol Nurs Forum. 2001 Aug;28(7):1125-32.
citation: Lazarus RS, Folkman S. (1984). Stress, appraisal, and coping. New York: Springer.
citation: Lee V, Robin Cohen S, Edgar L, Laizner AM, Gagnon AJ. Meaning-making intervention during breast or colorectal cancer treatment improves self-esteem, optimism, and self-efficacy. Soc Sci Med. 2006 Jun;62(12):3133-45. doi: 10.1016/j.socscimed.2005.11.041. Epub 2006 Jan 18.
citation: Lieberman MA, Golant M, Giese-Davis J, Winzlenberg A, Benjamin H, Humphreys K, Kronenwetter C, Russo S, Spiegel D. Electronic support groups for breast carcinoma: a clinical trial of effectiveness. Cancer. 2003 Feb 15;97(4):920-5. doi: 10.1002/cncr.11145.
citation: Liess A, Simon W, Yutsis M, Owen JE, Piemme KA, Golant M, Giese-Davis J. Detecting emotional expression in face-to-face and online breast cancer support groups. J Consult Clin Psychol. 2008 Jun;76(3):517-23. doi: 10.1037/0022-006X.76.3.517.
citation: Badia Llach X, Herdman M, Schiaffino A. Determining correspondence between scores on the EQ-5D "thermometer" and a 5-point categorical rating scale. Med Care. 1999 Jul;37(7):671-7. doi: 10.1097/00005650-199907000-00007.
citation: Meyer TJ, Mark MM. Effects of psychosocial interventions with adult cancer patients: a meta-analysis of randomized experiments. Health Psychol. 1995 Mar;14(2):101-8. doi: 10.1037//0278-6133.14.2.101.
citation: Newell SA, Sanson-Fisher RW, Savolainen NJ. Systematic review of psychological therapies for cancer patients: overview and recommendations for future research. J Natl Cancer Inst. 2002 Apr 17;94(8):558-84. doi: 10.1093/jnci/94.8.558.
citation: Nezu AM, Nezu CM, Friedman SH, Faddis S, Houts PS. (1998). Helping cancer patients cope: A problem- solving approach. Washinton, D.C.: American Psychological Association.
citation: Overcash J, Extermann M, Parr J, Perry J, Balducci L. Validity and reliability of the FACT-G scale for use in the older person with cancer. Am J Clin Oncol. 2001 Dec;24(6):591-6. doi: 10.1097/00000421-200112000-00013.
citation: Owen JE, Klapow JC, Hicken B, Tucker DC. Psychosocial interventions for cancer: review and analysis using a three-tiered outcomes model. Psychooncology. 2001 May-Jun;10(3):218-30. doi: 10.1002/pon.509.
citation: Owen JE, Yarbrough EJ, Vaga A, Tucker DC. (2003). Investigation of the effects of gender and preparation on quality of communication in Internet support groups. Comp Hum Behav, 19, 259-75.
citation: Owen JE, Klapow JC, Roth DL, Nabell L, Tucker DC. Improving the effectiveness of adjuvant psychological treatment for women with breast cancer: the feasibility of providing online support. Psychooncology. 2004 Apr;13(4):281-92. doi: 10.1002/pon.733.
citation: Owen JE, Klapow JC, Roth DL, Shuster JL Jr, Bellis J, Meredith R, Tucker DC. Randomized pilot of a self-guided internet coping group for women with early-stage breast cancer. Ann Behav Med. 2005 Aug;30(1):54-64. doi: 10.1207/s15324796abm3001_7.
citation: Owen JE, Giese-Davis J, Cordova M, Kronenwetter C, Golant M, Spiegel D. Self-report and linguistic indicators of emotional expression in narratives as predictors of adjustment to cancer. J Behav Med. 2006 Aug;29(4):335-45. doi: 10.1007/s10865-006-9061-8. Epub 2006 Jul 15.
citation: Owen JE, Goldstein MS, Lee JH, Breen N, Rowland JH. Use of health-related and cancer-specific support groups among adult cancer survivors. Cancer. 2007 Jun 15;109(12):2580-9. doi: 10.1002/cncr.22719.
citation: Pennebaker JW, Francis ME. (2001). Linguistic Inquiry and Word Count. Mahwah, NJ Erlbaum.
citation: Pew Internet and American Life Project (2003). How Californians compare to the rest of the nation. PIP: Washington, D.C.
citation: Pew Internet & American Life Project. (2007). E-patients with a disability or chronic disease. http://www.pewinternet.org/pdfs/EPatients_Chronic_Conditions_2007.pdf, last accessed on 1/16/08.
citation: Radloff LS. (1977). The CES-D scale: A self-report depression scale for research in the general population. App Psychol Measures, 1, 385-401.
citation: Rehse B, Pukrop R. Effects of psychosocial interventions on quality of life in adult cancer patients: meta analysis of 37 published controlled outcome studies. Patient Educ Couns. 2003 Jun;50(2):179-86. doi: 10.1016/s0738-3991(02)00149-0.
citation: Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma: a pilot study. Cancer. 1998 May 15;82(10):1904-8. doi: 10.1002/(sici)1097-0142(19980515)82:103.0.co;2-x.
citation: Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
citation: Spiegel D, Classen C. (2000). Group therapy for cancer patients: A research-based handbook of psychosocial care. New York: Basic Books.
citation: Stanton AL, Kirk SB, Cameron CL, Danoff-Burg S. Coping through emotional approach: scale construction and validation. J Pers Soc Psychol. 2000 Jun;78(6):1150-69. doi: 10.1037//0022-3514.78.6.1150.
citation: 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 Oct 15;20(20):4160-8. doi: 10.1200/JCO.2002.08.521.
citation: Vilela LD, Nicolau B, Mahmud S, Edgar L, Hier M, Black M, Franco EL, Allison PJ. Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. J Otolaryngol. 2006 Apr;35(2):88-96. doi: 10.2310/7070.2005.5002.
citation: Watts S, Edgar L. Nucare, a coping skills training intervention for oncology patients and families: participants' motivations and expectations. Can Oncol Nurs J. 2004 Spring;14(2):84-95. English, French.
citation: Weiss D, Marmar C. (1997). The Impact of Event Scale - Revised. In J. Wilson & T. Keane (Eds), Assessing psychological trauma and PTSD. New York: Guilford Press.
citation: Winzelberg AJ, Classen C, Alpers GW, Roberts H, Koopman C, Adams RE, Ernst H, Dev P, Taylor CB. Evaluation of an internet support group for women with primary breast cancer. Cancer. 2003 Mar 1;97(5):1164-73. doi: 10.1002/cncr.11174.
citation: Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
citation: Owen JE, O'Carroll Bantum E, Pagano IS, Stanton A. Randomized Trial of a Social Networking Intervention for Cancer-Related Distress. Ann Behav Med. 2017 Oct;51(5):661-672. doi: 10.1007/s12160-017-9890-4.