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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

ROK study-C (Rainbow of KIBOU study-colorectum): a colorectal cancer survivor cohort study on food, nutrition, physical activity, psychosocial factors and its influences on colorectal cancer recurrence, survival and quality of life in Japan

Authors: Yuri Mizota, Yukihide Kanemitsu, Shunsuke Tsukamoto, Dai Shida, Hiroki Ochiai, Seiichiro Yamamoto

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

Many studies have shown that lifestyle factors such as diet, physical activity are related to the incidence of cancer. However, there are few studies on the association between lifestyle factors and cancer prognosis. To investigate the influence of lifestyle factors and psychosocial factors on prognosis, we started a prospective study of women with breast cancer, the Rainbow of KIBOU study-Breast (ROK Study-B) in 2007. As of February 2018, more than 6300 women have been enrolled, thus making this one of the world’s largest cancer patient cohort studies. Based on the know-how obtained from this study, we started another new cohort study for colorectal cancer patient (ROK Study-C).

Methods

The ROK Study-C is a prospective observational study for colorectal cancer survivors at the National Cancer Center Hospital. Participants fill in several self-administrated questionnaires about lifestyle, psychosocial factors (including posttraumatic growth and benefit finding, support), and quality of life (QOL) 5 times in total: at diagnosis, 3 and 6 months, 1 and 5 years after surgery. CT-scans will be collected to assess body composition and obesity. We also use blood and cancer tissue from the Biobank. The primary endpoint is disease-free survival. The secondary endpoints are overall survival and health-related QOL. The planned sample size is 2000 and the follow-up period is 5 years after the last enrollment.

Discussion

Recruitment began in December 2015 and the study is still ongoing. The ROK Study-C will contribute to improvements in patient prognosis and yield important evidence for colorectal cancer survivorship.
Literature
1.
2.
3.
Rutten LJ, Arora NK, Bakos AD, Aziz N, Rowland J. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005;573:250–61.CrossRef
4.
Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM. Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. J Clin Oncol. 2005;23:5814–30.CrossRef
5.
Shea-Budgell MA, Kostaras X, Myhill KP, Hagen NA. Information needs and sources of information for patients during cancer follow-up. Curr Oncol. 2014;21:165–73.CrossRef
6.
Nissen N, Lunde A, Pedersen CG, Johannessen H. The use of complementary and alternative medicine after the completion of hospital treatment for colorectal cancer: findings from a questionnaire study in Denmark. BMC Complement Altern Med. 2014;14:388.CrossRef
7.
Sewitch MJ, Rajput Y. A literature review of complementary and alternative medicine use by colorectal cancer patients. Complement Ther Clin Pract. 2010;16:52–6.CrossRef
8.
9.
World Cancer Research Fund / American Institute for Cancer Research. Colorectal Cancer 2011 Report Food, nutrition, physical activity and the prevention of cancer: a global perspective 2011.
10.
World Cancer Research Fund International. Diet, nutrition, physical activity and Breast Cancer Survivors 2014. 2014.
11.
Vrieling A, Kampmanm E. The role of body mass index, physical activity, and diet in colorectal cancer recurrence and survival: a review of the literature. Am J Clin Nutr. 2010;92:471–90.CrossRef
12.
Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for Cancer survivors. CA Cncer J Clin. 2012;62:243–74.
13.
Mizota Y, Ohashi Y, Iwase T, Iwata H, Sawaki M, Kinoshita T, Taira N, Mukai H, Yamamoto S. Rainbow of KIBOU (ROK) study: a breast Cancer survivor cohort in Japan. Breast Cancer. 2018;25:60–7.CrossRef
14.
Meyerhardt JA, Niedzwiecki D, Hollis D, Saltz LB, Hu FB, Mayer RJ, Nelson H, Whittom R, Hantel A, Thomas J, Fuchs CS. Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA. 2007;298:754–64.CrossRef
15.
Maalmi H, Ordóñez-Mena JM, Schöttker B, Brenner H. Serum 25-hydroxyvitamin D levels and survival in colorectal and breast cancer patients: systematic review and meta-analysis of prospective cohort studies. Eur J Cancer. 2014;50:1510–21.CrossRef
16.
Sasaki S, Kobayashi M, Ishihara J, Tsugane S. Self-administered food frequency questionnaire used in the 5-year follow-up survey of the JPHC study: questionnaire structure, computation algorithms, and area-based mean intake. J Epidemiol. 2003;13:S13–22.CrossRef
17.
Ishihara J, Sobue T, Yamamoto S, Yoshimi I, Sasaki S, Kobayashi M, Takahashi T, Iitoi Y, Akabane M, Tsugane S. JPHC. Validity and reproducibility of a self-administered food frequency questionnaire in the JPHC study cohort II: study design, participant profile and results in comparison with cohort I. J Epidemiol. 2003;13:S134–47.CrossRef
18.
Sasaki S, Ishihara J, Tsugane S. Reproducibility of a self-administered food frequency questionnaire used in the 5-year follow-up survey of the JPHC study cohort I to assess food and nutrient intake. J Epidemiol. 2003;13:S115–24.CrossRef
19.
Sasaki S, Kobayashi M, Tsugane S. Validity of a self-administered food frequency questionnaire used in the 5-year follow-up survey of the JPHC study cohort I: comparison with dietary records for food groups. J Epidemiol. 2003;13:S57–63.CrossRef
20.
Hyodo I, Amano N, Eguchi K, Narabayashi M, Imanishi J, Hirai M, Nakano T, Takashima S. Nationwide survey on complementary and alternative medicine in cancer patients in Japan. J Clin Oncol. 2005;23:2645–54.CrossRef
21.
Ernst E, Schmidt K, Baum M. Complementary/alternative therapies for the treatment of breast cancer. A systematic review of randomized clinical trials and a critique of current terminology. Breast J. 2006;12:526–30.CrossRef
22.
Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006;24:3527–34.CrossRef
23.
Fujii H, Yamamoto S, Takeda-Imai F, Inoue M, Tsugane S, Kadowaki T, Noda M. Validity and applicability of a simple questionnaire for the estimation of total and domain-specific physical activity. Diabetol Int. 2011;2:47–54.CrossRef
24.
Evans PD, McIntyre NJ, Fluck RJ, McIntyre CW, Taal MW. Anthropomorphic measurements that include central fat distribution are more closely related with key risk factors than BMI in CKD stage 3. PLoS One. 2012;7:e34699.CrossRef
25.
Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013;31:1539–47.CrossRef
26.
Santin O, Murray L, Prue G, Gavin A, Gormley G, Donnelly M. Self-reported psychosocial needs and health-related quality of life of colorectal cancer survivors. Eur J Oncol Nurs. 2015;19:336–42.CrossRef
27.
Wu HS, Harden JK. Symptom burden and quality of life in survivorship: a review of the literature. Cancer Nurs. 2015;38:E29–54.CrossRef
28.
Ness S, Kokal J, Fee-Schroeder K, Novotny P, Satele D, Barton D. Concerns across the survivorship trajectory: results from a survey of cancer survivors. Oncol Nurs Forum. 2013;40:35–42.CrossRef
29.
Jansen L, Koch L, Brenner H, Arndt V. Quality of life among long-term (≥5 years) colorectal cancer survivors--systematic review. Eur J Cancer. 2010;46:2879–88.CrossRef
30.
Simmons KL, Smith JA, Bobb KA, Liles LL. Adjustment to colostomy: stoma acceptance, stoma care self-efficacy and interpersonal relationships. J Adv Nurs. 2007;60:627–35.CrossRef
31.
JR B, Petersen DM, Kang SH. Multi-dimensional quality of life among long-term (5+ years) adult cancer survivors. Psychooncology. 2007;16:691–706.CrossRef
32.
Ross L, Abild-Nielsen AG, Thomsen BL, Karlsen RV, Boesen EH, Johansen C. Quality of life of Danish colorectal cancer patients with and without a stoma. Support Care Cancer. 2007;15:505–13.CrossRef
33.
Sharma A, Walker AA, Sharp DM, Monson JR, Walker LG. Psychosocial factors and quality of life in colorectal cancer. Surgeon. 2007;5:344–54.CrossRef
34.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRef
35.
Frran CJ, Herth KA, Popovich JM. Hope and hopelessness: critical clinical constructs. London: Sage Publications; 1995.
36.
Lynch WF. Images of hope: imagination as healer of the hopeless. Notre Dame: University of Notre Dame Press; 1974.
37.
Mathews G. What makes life worth living? How Japanese and Americans make sense of their worlds. Berkeley: University of California Press; 1996.
38.
Mizota Y, Ozawa M, Yamazaki Y. Daily difficulty and desire of the bereaved: a study of bereaved families of HIV-infected hemophiliacs in Japan. Bull Soc Med. 2007;24:43–56.
39.
Nakanishi N, Fukuda H, Takatorige T, Tatara K. Relationship between self-assessed masticatory disability and 9-year mortality in a cohort of community-residing elderly people. J Am Geriatr Soc. 2005;53:54–8.CrossRef
40.
Koizumi M, Ito H, Kaneko Y, Motohashi Y. Effect of a sense of purpose in life on the risk of death from cardiovascular disease. J Epidemiol. 2008;18:191–6.CrossRef
41.
Tanno K, Sakata K; Japan Collaborative Cohort Study for Evaluation of Cancer. Psychological factors and mortality in the Japan Collaborative Cohort Study for Evaluation of Cancer (JACC). Asian Pac J Cancer Prev. 2007;8 Suppl:113–22.
42.
Sone T, Nakaya N, Ohmori K, Shimazu T, Higashiguchi M, Kakizaki M, Kikuchi N, Kuriyama S, Tsuji I. Sense of life worth living (Ikigai) and mortality in Japan: Ohsaki study. Psychosom Med. 2008;70:709–15.CrossRef
43.
Wakai K, Kojima M, Nishio K, Suzuki S, Niwa Y, Lin Y, Kondo T, Yatsuya H, Tamakoshi K, Yamamoto A, Tokudome S, Toyoshima H, Tamakoshi A, JACC Study Group. Psychological attitudes and risk of breast cancer in Japan: a prospective study. Cancer Causes Control. 2007;18:259–67.CrossRef
44.
45.
Stephenson C. The concept of hope revisited for nursing. J Adv Nurs. 1991;16:1456–61.CrossRef
46.
Miller JF. Hope-inspiring strategies of the critically ill. Appl Nurs Res. 1989;2:23–9.CrossRef
47.
Chen M-L. Pain and hope in patients with cancer. Cancer Nurs. 2003;26:61–7.CrossRef
48.
Herth K. The relationship between level of hope and level of coping response and other variables in cancer patients. Oncol Nurs Forum. 1989;16:67–72.PubMed
49.
Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992;17:1251–9.CrossRef
50.
Joseph S, Williams R, Yule W. Understanding post-traumatic stress: a psychosocial perspective on PTSD and treatment. Chichester: Wiley; 1997.
51.
Wilson JP, Keane TM, editors. Assessing psychological trauma and PTSD. New York: The Guilford Press; 1997.
52.
van der Kolk BA, McFarlane AC, Weisaeth L, editors. Traumatic stress: the effects of overwhelming experience on mind, body, and society. New York: The Guilford Press; 1996.
53.
Tedeschi RG, Calhoun LG. Posttraumatic growth: conceptual foundations and empirical evidence. Psychol Inq. 2004;15:1–18.CrossRef
54.
Linley PA, Joseph S. Positive change following trauma and adversity: a review. J Traumatic Stress. 2004;17:11–21.CrossRef
55.
Joseph S, Linley PA, Harris GJ. Understanding positive change following trauma and adversity: structural clarification. J Loss Trauma. 2005;10:83–96.CrossRef
56.
Joseph S, Linley PA. Editors. Trauma, recovery, and growth. New Jersey: John Wiley & Sons, Inc; 2008.CrossRef
57.
Rinaldis M, Pakenham K, Lynch BM. Relationships between quality of life and finding benefits in a diagnosis of colorectal cancer. Br J Psychol. 2010;101(Pt 2):259–75.CrossRef
58.
Jansen L, Hoffmeister M, Chang-Claude J, Brenner H, Arndt V. Benefit finding and post-traumatic growth in long-term colorectal cancer survivors: prevalence, determinants, and associations with quality of life. Br J Cancer. 2011;105:1158–65.CrossRef
59.
Occhipinti S, Chambers SK, Lepore S, Aitken J, Dunn J. A longitudinal study of post-traumatic growth and psychological distress in colorectal Cancer survivors. PLoS One. 2015;10:e0139119.CrossRef
60.
Watanabe T, Muro K, Ajioka Y, Hashiguchi Y, Ito Y, Saito Y, Hamaguchi T, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kawano H, Kinugasa Y, Kokudo N, Murofushi K, Nakajima T, Oka S, Sakai Y, Tsuji A, Uehara K, Ueno H, Yamazaki K, Yoshida M, Yoshino T, Boku N, Fujimori T, Itabashi M, Koinuma N, Morita T, Nishimura G, Sakata Y, Shimada Y, Takahashi K, Tanaka S, Tsuruta O, Yamaguchi T, Yamaguchi N, Tanaka T, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer. Int J Clin Oncol. 2017. doi: https://​doi.​org/​10.​1007/​s10147-017-1101-6.CrossRef
61.
Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 2017 2:217–27.
62.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRef
63.
Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM, European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009;45:3017–26.CrossRef
64.
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993;36:77–97.CrossRef
65.
Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American urological association symptom index for benign prostatic hyperplasia. The measurement Committee of the American Urological Association. J Urol. 1992;148:1549–57.CrossRef
66.
Homma Y, Yoshida M, Seki N, Yokoyama O, Kakizaki H, Gotoh M, Yamanishi T, Yamaguchi O, Takeda M, Nishizawa O. Symptom assessment tool for overactive bladder syndrome--overactive bladder symptom score. Urology. 2006;68:318–23.CrossRef
67.
Homma Y, Fujimura T. Linguistic validation of the English version of the overactive bladder symptom score. Int J Urol. 2014;21:229.CrossRef
68.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–30.CrossRef
69.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191–208.CrossRef
70.
Takahashi M, Inokuchi T, Watanabe C, Saito T, Kai I. The female sexual function index (FSFI): development of a Japanese version. J Sex Med. 2011;8:2246–54.CrossRef
Metadata
Title
ROK study-C (Rainbow of KIBOU study-colorectum): a colorectal cancer survivor cohort study on food, nutrition, physical activity, psychosocial factors and its influences on colorectal cancer recurrence, survival and quality of life in Japan
Authors
Yuri Mizota
Yukihide Kanemitsu
Shunsuke Tsukamoto
Dai Shida
Hiroki Ochiai
Seiichiro Yamamoto
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4830-7

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