A prospective, multicenter, cohort study to evaluate the long-term quality of life and psychological factors among patients with breast cancer, 5-year follow-up: a study protocol

doi:10.21203/rs.3.rs-2349479/v2

Background: Breast cancer is the most commonly occurring cancer among women worldwide. Quality of life and psychological status of patients with breast cancer could be affected after diagnosis, especially during treatment. The main objective of this study is investigation of long-term influence of breast cancer on quality of life’s dimensions and mental health status.

Methods: This is a multicenter, ongoing longitudinal prospective cohort study which administered in national institute for medical research development in May 2018 in Iran. 1250 patients with breast cancer who were completed their treatments, will be recruited from 5 referral medical centers located in Tehran, to be followed for 5 years. Questionnaires for evaluating the primary and secondary outcomes will be complete by trained investigators during face-to-face interviews with each participant in three phases: immediately after treatment, 1 year and 5 years later. Data will be collected on socio-demographic, quality of life, body image, hope, psychological problems such as anxiety, depression and mood, also sexual function and physical activity. Data will be analyzed in each phase and at the end of the project by SPSS version 22.

Discussion: It is the first nationwide, prospective, cohort study with large sample size, long-term follow-up and broad research aims which will evaluate quality of life-related factors in Iranian breast cancer population to justify the existing gap in literature.

Trial registration number: National Institute for Medical Research Development (NIMAD) (IR.NIMAD.REC.1397.322) July 1th, 2018.

Breast neoplasms

Cohort

Depression

Follow-Up study

Iran

Quality of life

Study protocol

Breast cancer (BC) is the most commonly occurring cancer among women with 2.3 million new incidence and 684,679 deaths globally per year. BC incidence and mortality rates are high in developed and developing countries (1). The incidence rate of BC in Iran had a significant upward trend and it’s also considered as a major reason of death in Iranian females (2-4).

Advances for BC detection and treatment lead to the longer expected survival time of patients (5) that’s why the QoL is one of the major concerning health issues among them. QoL can be important in predicting the outcomes of patients’ disease and could consider as a prognostic factor along with other medical parameters.

Patients might experience several side-effects including sleep disturbance, psychosocial distress and depression after being diagnosed and treated for BC which could detrimentally affect QoL (6-8). So, QoL assessment could determine how BC diagnosis and related treatment could affect QoL.

Based on previous studies, QoL among BC patients is related with several psychological factors such as depression, anxiety (9), sleep disturbances (10), spiritual (11, 12), sexual (13-16), and cognitive disorders (17, 18). Furthermore, some of physical aspects including pain (19, 20), hot flashes, night sweats, vaginal dryness (21), lymphedema (22), fatigue (23-25), peripheral neuropathy and gastrointestinal problems (26). BC patient’s life style behaviors (27-29) and fear of cancer recurrence (30) could also be considered as crucial determinants of QoL.

Recent studies showed high prevalence of anxiety and depression in patients with BC (7, 31). Furthermore, sexual dysfunction (32-34) which exist due to fear of rejection (35, 36) or feeling sexually unattractive (35, 37) and body image dissatisfaction (38-43) should be considered as other problems which could occur in this population.

On the other hand, QoL could depend on some demographical features like age (44), educational (45) and marital status (46). Recent study had demonstrated that women with BC who were before 50 years old experience lower QoL in compared with older patients (47).

Actually, women play a crucial role in family life and their overall wellbeing after BC diagnosis could definitely affect other family members lives (48), Therefore assessing QoL is essential since it could significantly affect the process of treatment and survival (49-51). The shock of BC diagnostic, mental and physical disorders made by side effects of cancer treatments and fearing of recurrence after completion of treatments could have deteriorate influence on patients’ QoL which made the beginning, during and the end of cancer treatment as three crucial time points , when we choose for assessing outcomes among BC patients (52, 53).

While early and immediate screening and monitoring after BC diagnosis could improve QoL in survivors, the primary purpose of current study is collecting and evaluating the impact of BC diagnosis on long term QoL, psychological and physical activity status, which is an essential step towards addressing this paucity of knowledge. Moreover, the data of this cohort could also be used to obtain approaches for BC survivorship care over time.

Study design:

This prospective cohort study was designed to evaluate a cohort of 1250 women with BC, during a 5-year follow-up (Fig 1).

Eleven questionnaires will be used in three phases including; baseline (immediately after treatment) and at 1 and 5 years after enrollment. Data will be collected up to five years post BC diagnosis through semi-structured interviews in order to accurately document the subsequent outcomes of patients within the follow up period. In each center, trained interviewers or clinicians obtain information by filling questionnaires through personal interview (face-to-face) (Fig 1).

Selection of participants:

This study takes place at 5 main referral centers including Rasoul Akram, Imam Hossein, Mahdiye and Imam Khomeini Hospitals and Motamed Cancer Institute. The study team attempt to engage with these centers for case identification.

The originally-planned start was delayed due to COVID-19 health and safety protocols. Our study team postponed planned in-person recruitment activities until 2021.

Women should have following conditions in order to participate in this cohort:

1. Women aged 18 years or older

2- Histological confirmed BC diagnosed

3- Within the first month after active BC treatment completion (chemotherapy, radiation, surgery)

4- capable of understanding the purposes of the study and willing to collaborate

Also participants were excluded if they develop metastatic cancer in any stages.

After explaining the purpose of this cohort by researchers, written consent form will be signed by persons who want to participate. Participants will be informed that they could chose to withdraw from the study at any time. Since transportation to and from hospitals may be difficult for several participants and they might not be able to get there for our study, we will set the date for face to face intervention in accordance with their oncologist or surgeon checkup date to minimize the possible discomfort. This approach will be continued as the same in the next phases. Researchers ensure participants to protect their identity throughout recruitment and dissemination process, and to promote clear and honest research reporting.

Study questionnaires:

Participants will receive questionnaires that should be filled out by face-to-face interview at baseline and at different stages of follow-up. Socio-demographic and clinical characteristics information (age, marital, educational, economic and occupational status, family history of cancer, history of mental disease, date of diagnosis, tumor characteristics (grade, stage, hormone receptor status), type of cancer treatment (chemotherapy, surgery, radiation therapy, hormone therapy), physical, mental or cognitive side effects of treatment) will be collected through researcher-made questionnaire and patients’ medical records at the beginning of the study. Other outcomes will evaluate by questionnaires which validated for the Iranian population. These instruments will assess QoL (54-57), anxiety (58), depression (58, 59), mood (60), sexual function (61), body image (62), hope (63), physical activity (64). The detailed of these questionnaires described in Table 1.

Data analysis and sample size:

All statistical analysis will be performed using SPSS 22.0. Demographic characteristics and medical history of patients will be described by using Mean and SD, median, lower and upper quartile values and frequencies (%) depending on the type of variables.

Chi‑square test will be used for categorical variables in order to evaluate the association between socio-demographic, clinical characteristics and symptoms with the dependent variables. Also t-test will be used to identify relevance of variables. P < 0.05 would be considered as statistically significant.

Sample size was calculated 1250 women that will be selected 200-250 individuals in each centers.

The survival of patients with BC could remarkably be affected by their QoL and psychological status. Despite the high prevalence of BC in our country and the critical role of QoL, emotional, psychological, and social well-being on this population, no population-based cohort survey have been carried out to assess the longitudinal QoL and other related characteristics among women with BC in Iran.

This prospective, multicenter, cohort study is the first nationwide project with large sample size, long-term follow-up and broad research aims that is investigating health-related QoL dimensions, psychological factors, sexual and physical activity status during 5 years among Iranian breast cancer survivors after completing active cancer treatment to justify the existing gap in literature.

High quality evidence that will be provided by this cohort could play a critical role for investigating effective lifestyle approaches for improving QoL, psychological status and overall survival among our target population.

Furthermore, developing standard valid questionnaires and guidelines for long term screening and monitoring of patients after BC diagnosis is the other goals of this project. We could also identify the main predictors and risk factors of poor health-related QoL or mental disorders after completion of BC treatment until 5 years among this population.

One of the main strengths of this protocol is that in this study participants recruit from 5 main referral centers for cancer treatment in Iran where located in Tehran province and high percentage of patients from other provinces are also referred to these centers for initiation of their cancer treatment annually and this could help us evaluate outcomes among BC patients with different lifestyle, geographic and socioeconomic status. Moreover, the interviewing method in this study is face-to-face (in-person) interview which is effective, feasible and flexible data collection method in obtaining accurate information and higher response rate, especially among the patients after active treatment who may not immediately able to response or understand the questions. Other than that The findings of this study will help physicians, oncologists, psychologists and nutritionists to design instructions for the management and care of patients with BC and training their families. A major limitation of this study is that BC specific death will not be assessed as the primary outcome. Therefore, the power of this study may not be adequate to show a clinical significance. Furthermore, since this is a cohort study, inaccessibility of all participants in the second or third phase due to non-assistance or death could consider as a limitation.

BC: Breast cancer; QoL: Quality of life.

Ethics approval and consent to participate

The study protocol was approved by Ethics committee of the National Institute for Medical Research Development (NIMAD) with approval ID of IR.NIMAD.REC.1397.322. Written informed consent to participate will be registered for all enrolled patients. The findings of the study will be disseminated through scientific peer-reviewed journals, national and international conference presentations, and also will be accessible for patients, clinicians and public.

Consent for publication

A signed informed consent will be obtained from each participant.

Availability of data and materials

The datasets will be available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This study is supported by National Institute for Medical Research Development Islamic Republic of Iran with number 964822.

Author’s contribution

MRL, AS, AM participated in the design and coordination of the study. AK and FA are the biostatisticians of the study. RA, RO, NN, LH and MR reviewed the study protocol and made suggestions that improved the design. All of these individuals are involved in the management of the study. MRL and EH drafted the manuscript. All of the authors read, revised and approved the final manuscript.

Acknowledgements
This research has received a grant from the National Institute for Medical Research Development (NIMAD), (IR.NIMAD.REC.1397.322). The authors would like to thank the oncologists and surgeons who are participating in the follow-up of the patients.

Author details

¹Integrative Oncology and Quality of life Department, Breast Cancer Research Center, Motamed Cancer Institute, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran. ²Population Health Research Group, Health Metrics Research Centre, Iranian Institute for Health Sciences Research, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran. ³Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ⁴Department of Surgical Oncology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran. ⁵Breast Disease Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran. ⁶Department of Surgery, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran. ⁷Department of Counseling, Faculty of Educational Sciences and Psychology, Kharazmi University, Tehran, Iran. ⁸Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. ⁹Research Center for Health Management in Mass Gathering, Red Crescent Society of the Islamic Republic of Iran, Tehran, Iran.

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians. 2021;71(3):209-49.
Kulhánová I, Bray F, Fadhil I, Al-Zahrani AS, El-Basmy A, Anwar WA, et al. Profile of cancer in the Eastern Mediterranean region: The need for action. Cancer epidemiology. 2017;47:125-32.
Burden of cancer in the Eastern Mediterranean Region, 2005–2015: findings from the Global Burden of Disease 2015 Study. International Journal of Public Health. 2018;63:151-64.
Enayatrad M, Mirzaei M, Salehiniya H, Karimirad MR, Vaziri S, Mansouri F, et al. Trends in incidence of common cancers in Iran. Asian Pacific Journal of Cancer Prevention. 2016;17(sup3):39-42.
Daldoul A, Khechine W, Bhiri H, Ammar N, Bouriga R, Krir MW, et al. Factors predictive of quality of life among breast cancer patients. Asian Pacific Journal of Cancer Prevention: APJCP. 2018;19(6):1671.
Paraskevi T. Quality of life outcomes in patients with breast cancer. Oncology reviews. 2012;6(1).
McFarland DC, Shaffer KM, Tiersten A, Holland J. Physical symptom burden and its association with distress, anxiety, and depression in breast cancer. Psychosomatics. 2018;59(5):464-71.
Tsaras K, Papathanasiou IV, Mitsi D, Veneti A, Kelesi M, Zyga S, et al. Assessment of depression and anxiety in breast cancer patients: prevalence and associated factors. Asian Pacific journal of cancer prevention: APJCP. 2018;19(6):1661.
Maass SW, Roorda C, Berendsen AJ, Verhaak PF, de Bock GH. The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: a systematic review. Maturitas. 2015;82(1):100-8.
Lowery-Allison AE, Passik SD, Cribbet MR, Reinsel RA, O'Sullivan B, Norton L, et al. Sleep problems in breast cancer survivors 1–10 years posttreatment. Palliative & supportive care. 2018;16(3):325-34.
Mollica MA, Nemeth LS, Newman SD, Mueller M, Sterba K. Peer navigation in African American breast cancer survivors. Patient related outcome measures. 2014;5:131.
Harandy TF, Ghofranipour F, Montazeri A, Anoosheh M, Bazargan M, Mohammadi E, et al. Muslim breast cancer survivor spirituality: coping strategy or health seeking behavior hindrance? Health care for women international. 2009;31(1):88-98.
Ganz PA. Improving outcomes for breast cancer survivors: Perspectives on research challenges and opportunities: Springer; 2015.
Ganz PA, Rowland JH, Desmond K, Meyerowitz BE, Wyatt GE. Life after breast cancer: understanding women's health-related quality of life and sexual functioning. Journal of Clinical Oncology. 1998;16(2):501-14.
Harirchi I, Montazeri A, Zamani Bidokhti F, Mamishi N, Zendehdel K. Sexual function in breast cancer patients: a prospective study from Iran. Journal of Experimental & Clinical Cancer Research. 2012;31(1):1-6.
Dow J, Kennedy Sheldon L. Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Clinical Journal of Oncology Nursing. 2015;19(4).
Schagen SB, Muller MJ, Boogerd W, Mellenbergh GJ, Van Dam FS. Change in cognitive function after chemotherapy: a prospective longitudinal study in breast cancer patients. Journal of the National Cancer Institute. 2006;98(23):1742-5.
de Ruiter MB, Reneman L, Boogerd W, Veltman DJ, Van Dam FS, Nederveen AJ, et al. Cerebral hyporesponsiveness and cognitive impairment 10 years after chemotherapy for breast cancer. Human brain mapping. 2011;32(8):1206-19.
Hamood R, Hamood H, Merhasin I, Keinan-Boker L. Chronic pain and other symptoms among breast cancer survivors: prevalence, predictors, and effects on quality of life. Breast cancer research and treatment. 2018;167(1):157-69.
Jaremka LM, Nadzan MA. Threats to belonging among breast cancer survivors: Consequences for mental and physical health. Current Breast Cancer Reports. 2018;10(1):1-6.
Rosenberg SM, Partridge AH. Premature menopause in young breast cancer: effects on quality of life and treatment interventions. Journal of thoracic disease. 2013;5(Suppl 1):S55.
Taghian NR, Miller CL, Jammallo LS, O’Toole J, Skolny MN. Lymphedema following breast cancer treatment and impact on quality of life: a review. Critical reviews in oncology/hematology. 2014;92(3):227-34.
Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health and quality of life outcomes. 2009;7(1):1-21.
Heydarnejad MS, Hassanpour DA, Solati DK. Factors affecting quality of life in cancer patients undergoing chemotherapy. African health sciences. 2011;11(2).
Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. Journal of clinical oncology. 2000;18(4):743-.
Alfano CM, Ganz PA, Rowland JH, Hahn EE. Cancer survivorship and cancer rehabilitation: revitalizing the link. J Clin Oncol. 2012;30(9):904-6.
Swisher AK, Abraham J, Bonner D, Gilleland D, Hobbs G, Kurian S, et al. Exercise and dietary advice intervention for survivors of triple-negative breast cancer: effects on body fat, physical function, quality of life, and adipokine profile. Supportive Care in Cancer. 2015;23(10):2995-3003.
Soerjomataram I, Louwman MW, Ribot JG, Roukema JA, Coebergh JWW. An overview of prognostic factors for long-term survivors of breast cancer. Breast cancer research and treatment. 2008;107(3):309-30.
Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, et al. Associations between lifestyle factors and quality of life among older long‐term breast, prostate, and colorectal cancer survivors. Cancer: Interdisciplinary International Journal of the American Cancer Society. 2009;115(17):4001-9.
Cohee AA, Adams RN, Johns SA, Von Ah D, Zoppi K, Fife B, et al. Long‐term fear of recurrence in young breast cancer survivors and partners. Psycho‐oncology. 2017;26(1):22-8.
An Y, Fu G, Yuan G. Quality of life in patients with breast cancer: the influence of family caregiver's burden and the mediation of patient's anxiety and depression. The Journal of Nervous and Mental Disease. 2019;207(11):921-6.
Goldfarb S, Dickler M, Sit L, Fruscione M, Barz T, Atkinson T, et al. Sexual dysfunction in women with breast cancer: prevalence and severity. Journal of Clinical Oncology. 2009;27(15_suppl):9558-.
Emilee G, Ussher JM, Perz J. Sexuality after breast cancer: a review. Maturitas. 2010;66(4):397-407.
Raggio GA, Butryn ML, Arigo D, Mikorski R, Palmer SC. Prevalence and correlates of sexual morbidity in long-term breast cancer survivors. Psychology & health. 2014;29(6):632-50.
Gilbert E, Ussher JM, Perz J. Renegotiating sexuality and intimacy in the context of cancer: the experiences of carers. Archives of sexual behavior. 2010;39(4):998-1009.
Henson HK. Breast cancer and sexuality. Sexuality and disability. 2002;20(4):261-75.
Burwell SR, Case LD, Kaelin C, Avis NE. Sexual problems in younger women after breast cancer surgery. J Clin Oncol. 2006;24(18):2815-21.
Boquiren VM, Esplen MJ, Wong J, Toner B, Warner E, Malik N. Sexual functioning in breast cancer survivors experiencing body image disturbance. Psycho‐Oncology. 2016;25(1):66-76.
Brunet J, Sabiston CM, Burke S. Surviving breast cancer: women's experiences with their changed bodies. Body image. 2013;10(3):344-51.
Collins KK, Liu Y, Schootman M, Aft R, Yan Y, Dean G, et al. Effects of breast cancer surgery and surgical side effects on body image over time. Breast cancer research and treatment. 2011;126(1):167-76.
Falk Dahl CA, Reinertsen KV, Nesvold IL, Fosså SD, Dahl AA. A study of body image in long‐term breast cancer survivors. Cancer. 2010;116(15):3549-57.
Koçan S, Gürsoy A. Body image of women with breast cancer after mastectomy: A qualitative research. The journal of breast health. 2016;12(4):145.
Paterson C, Lengacher CA, Donovan KA, Kip KE, Tofthagen CS. Body image in younger breast cancer survivors: a systematic review. Cancer nursing. 2016;39(1):E39.
Leinert E, Singer S, Janni W, Harbeck N, Weissenbacher T, Rack B, et al. The impact of age on quality of life in breast cancer patients receiving adjuvant chemotherapy: a comparative analysis from the prospective multicenter randomized ADEBAR trial. Clinical breast cancer. 2017;17(2):100-6.
Sharma N, Purkayastha A. Factors affecting quality of life in breast cancer patients: a descriptive and cross-sectional study with review of literature. Journal of mid-life health. 2017;8(2):75.
Peuckmann V, Ekholm O, Rasmussen NK, Møller S, Groenvold M, Christiansen P, et al. Health-related quality of life in long-term breast cancer survivors: nationwide survey in Denmark. Breast cancer research and treatment. 2007;104(1):39-46.
Cohee AA, Bigatti SM, Shields CG, Johns SA, Stump T, Monahan PO, et al. Quality of life in partners of young and old breast cancer survivors. Cancer nursing. 2018;41(6):491.
Salganicoff M. Women in family businesses: Challenges and opportunities. Family Business Review. 1990;3(2):125-37.
Perry S, Kowalski TL, Chang C-H. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health and Quality of life Outcomes. 2007;5(1):1-14.
King CR, editor Advances in how clinical nurses can evaluate and improve quality of life for individuals with cancer. Oncology nursing forum; 2006: Oncology Nursing Society.
Grimison PS, Stockler MR. Quality of life and adjuvant systemic therapy for early-stage breast cancer. Expert review of anticancer therapy. 2007;7(8):1123-34.
Hanson Frost M, Suman VJ, Rummans TA, Dose AM, Taylor M, Novotny P, et al. Physical, psychological and social well‐being of women with breast cancer: the influence of disease phase. Psycho‐Oncology: Journal of the Psychological, Social and Behavioral Dimensions of Cancer. 2000;9(3):221-31.
Schnipper HH. Life after breast cancer. Journal of Clinical Oncology. 2001;19(15):3581-4.
Patoo M, Allahyari AA, Moradi AR, Payandeh M. Persian version of functional assessment of Cancer therapy-breast (FACT-B) scale: confirmatory factor analysis and psychometric properties. Asian Pacific Journal of Cancer Prevention. 2015;16(9):3799-803.
Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Quality of life research. 2005;14(3):875-82.
Montazeri A, Harirchi I, Vahdani M, Khaleghi F, Jarvandi S, Ebrahimi M, et al. The EORTC breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23): translation and validation study of the Iranian version. Quality of Life Research. 2000;9(2):177-84.
Montazeri A, Harirchi I, Vahdani M, Khaleghi F, Jarvandi S, Ebrahimi M, et al. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): translation and validation study of the Iranian version. Supportive Care in Cancer. 1999;7(6):400-6.
Montazeri A, Vahdaninia M, Ebrahimi M, Jarvandi S. The Hospital Anxiety and Depression Scale (HADS): translation and validation study of the Iranian version. Health and quality of life outcomes. 2003;1(1):1-5.
Stefan-Dabson K, Mohammadkhani P, Massah-Choulabi O. Psychometrics characteristic of Beck Depression Inventory-II in patients with magor depressive disorder. Archives of Rehabilitation. 2007;8:82-0.
FAROKHI A, MOTESHAREIE E, ZEIDABADY R. Validity and reliability of Persian version of Brunel mood scale 32 items. 2013.
Fakhri A, Pakpour AH, Burri A, Morshedi H, Zeidi IM. The Female Sexual Function Index: translation and validation of an Iranian version. The journal of sexual medicine. 2012;9(2):514-23.
Pooravari M, Habibi M, Parija HA, Tabar SHSA. Psychometric properties of body image concern inventory in adolescent. Pajoohandeh Journal. 2014;19(4):189-99.
Vakili Y, Ghanbari N, Nooripour R, Ilanloo H, Matacotta JJ, Mansournia MA. Validity of the Snyder's Adult Hope Scale (AHS) among Iranian Women with Breast Cancer. Archives of Breast Cancer. 2022:96-103.
Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian journal of sports medicine. 2011;2(2):106.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, 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. JNCI: Journal of the National Cancer Institute. 1993;85(5):365-76.
Fayers P, Bottomley A, Group EQoL. Quality of life research within the EORTC—the EORTC QLQ-C30. European Journal of Cancer. 2002;38:125-33.
Fayers P, Aaronson N, Bjordal K, Groenvold M, Curran D, Bottomley A. EORTC QLQ-C30 Scoring Manual. edition. Brussels; 2001.
Fayers P, Aaronson NK, Bjordal K, Sullivan M. EORTC QLQ–C30 scoring manual: European Organisation for Research and Treatment of Cancer; 1995.
Tajvar M, Arab M, Montazeri A. Determinants of health-related quality of life in elderly in Tehran, Iran. BMC public health. 2008;8(1):1-8.
Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Medical care. 1992:473-83.
Jenkinson C, Layte R, Coulter A, Wright L. Evidence for the sensitivity of the SF-36 health status measure to inequalities in health: results from the Oxford healthy lifestyles survey. Journal of Epidemiology & Community Health. 1996;50(3):377-80.
Cella DF, Tulsky DS. Quality of life in cancer: definition, purpose, and method of measurement. Cancer investigation. 1993;11(3):327-36.
Cella D. FACIT manual: manual of the functional assessment of chronic illness therapy (FACIT) scales. Evanston, IL: Evanston Northwestern Healthcare and Northwestern University. 1997.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta psychiatrica scandinavica. 1983;67(6):361-70.
Steer RA, Rissmiller DJ, Beck AT. Use of the Beck Depression Inventory-II with depressed geriatric inpatients. Behaviour research and therapy. 2000;38(3):311-8.
Milton K, Lane A, Terry P. Personality does not influence exercise-induced mood enhancement among female exercisers. Journal of sports medicine and physical fitness. 2005;45(2):208.
Brandt R, Herrero D, Massetti T, Crocetta TB, Guarnieri R, de Mello Monteiro CB, et al. The Brunel Mood Scale rating in mental health for physically active and apparently healthy populations. Health. 2016;8(2):125-32.
Keen K, Maples J, Cooley B, Olenick A, Blankenship M, Hoover D. Acute high-intensity exercise improves mood during the second trimester of pregnancy. Int J Womens Health Wellness. 2017;3(053):2474-1353.
Ghassamia M, Asghari A, Safarinejad MR. Validation of psychometric properties of the Persian version of the Female Sexual Function Index. Urology Journal. 2013;10(2).
Rosen CB, J. Heiman, S. Leiblum, C. Meston, R. Shabsigh, D. Ferguson, R. D'Agostino, R. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Journal of sex & marital therapy. 2000;26(2):191-208.
Littleton HL, Axsom D, Pury CL. Development of the body image concern inventory. Behaviour Research and therapy. 2005;43(2):229-41.
Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of personality and social psychology. 1996;70(2):321.
Forde C. Scoring the international physical activity questionnaire (IPAQ). University of Dublin. 2018;3.

Table 1. Description of instruments used for evaluation of the participants.

Validity/Reliability	Score	Domain/Subscales		Description	Instruments
Montazeri et al. validated the Iranian version of the EORTC QLQ-C30 in cancer patients (57). Crohnbach's alpha coefficient for multi-item scales ranged from 0.48 to 0.95 and Validity was checked using two methods: inter-scale correlation and known-groups comparison.	Range: 0-100. Higher scores for the global health status and functional scale represent a better level of QoL and functioning. Higher scores for a symptom scale/item represents a higher level of symptomatology/ problems	Global health status. Functional scales: Physical, role, emotional, cognitive and social functioning. Symptom scales/items: Fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.		Scale with 30 questions assessing QoL among patients with cancer during the previous week	Iranian version of EORTC QLQ-C30 (65-67)
Iranian version of the EORTC QLQ-BR23 is a reliable tool which was validated by Montazeri et al in breast cancer patients (56). Cronbach's α coefficient for multi-item scales ranged from 0.63 to 0.95.	Range: 0-100. Higher scores for a functional scale represent a healthy level of functioning. Higher scores for a symptom scale/item represent a higher level of symptomatology/ problems	Functional scales: body image, sexual functioning, sexual enjoyment, future perspective. Symptom scales/items: systemic therapy side effects, breast symptoms, arm symptoms, concern about hair loss.		Specific breast cancer scale with 23 questions assessing QoL in patients with breast cancer during the previous week and month.	Iranian version of EORTC QLQ-BR23 (68)
The Iranian version of the SF-36 is known as a reliable and valid instrument which evaluated by Monrazeri et al. Cronbach's α coefficients ranging from 0.77 to 0.90 (α =0.65) (55).	Range: 0-100. Scores ranged from 0 (worst health status) to 100 (best health status) for each subscale that higher scores indicating a better condition.	Physical functioning, Role physical, Bodily pain, General health, Vitality, Social functioning, Role emotional and Mental health. Energy/fatigue, Emotional well-being, Social Functioning, pain, it also provides two summary scales, Physical component summary and mental component summary.		The Short Form Healthy Survey is a generic instrument with 8 subscales for assessing health related QoL.	Iranian version of SF-36 (69-71)
The Persian version of the FACT-B is validated by Patoo et al. (54) Internal consistency using Cronbach’s alpha was 0.63 to 0.93 for the subscales and 0.92 for the total scale.	Range: 0-144. The scoring method of FACT-B is in Likert’s scale and responses were recorded on a 5-point Likert scale, and a higher score indicates a better QoL of patient. (Ranging from 0 to 4, where 0 represents ‘not at all’, 1 - a little bit, 2 - somewhat, 3 - quite a bit and 4 - very much).	Consists of two parts: the general subscale on cancer (FACT-G) and additional concerns on breast cancer-specific subscale (BCS). The FACT-G includes physical well-being (seven items), social/ family well-being (seven items), emotional wellbeing (six items), and functional well-being (seven items) and the BCS has nine items.		The FACT-B is a sensitive, disease-specific instrument with 5 subscales for measuring the QoL of breast cancer patients.	Iranian version of FACT-B (72, 73)
(58) The Persian version of HADS is an acceptable tool which reliability and validity was confirmed by Montazeri et al. Cronbach's alpha coefficient has been found to be 0.78 for the HADS anxiety sub-scale and 0.86 for the HADS depression sub-scale	Each item is ranked on the 4-point Likert scale (0 to 3). Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8–10 represents 'borderline' and 0–7 'normal'.	Including 14 items in 2 subscales: Anxiety and Depression		this instrument is a brief scale with 14 questions to measure anxiety and emotional distress in patients during the previous week	Iranian version of HADS (74)
The Persian version of BDI-II has demonstrated acceptable psychometric properties of validity and reliability in different populations (59). The reliability of the instrument is Cronbach's α = 0.87and acceptable test-retest reliability (r = 0.74).	Range: 0-63 BDI-II have 21-items which are rating on a 4-point Likert scale (0 to 3) The score of 0–9 was not depressed. From 10 to 15 points are mild depressed states, 16–23 points are moderate depressed, and 24–63 points are severe depressed.	BDI-II have 21-items		Beck depression inventory-II is a self -reported tool for assessing depression in general population.	Iranian version of BDI (75)
Farokhi Ahmad et al. proved reliability and validity of Persian version of the BRUMS-32 for assessing mood among Iranian population (with internal consistency of 0.78 and temporal reliability of 0.88) (60)	Final score questionnaire can be calculated by taking the sum negative dimensions and then subtracting the sum of positive dimensions. Thus positive scores reflected distress mood and negative scores represent good mood	It is included 8 Positive dimensions subscales vigor, calmness, happy, also negative dimensions subscales anger, tension, depression, fatigue and confusion		The BRUMS-32 including 32 questions evaluated two aspects positive and negative’s mood in athletes	Iranian version of Brums-32 (76-78)
In Iran the validity and reliability FSFI questionnaire have been proved in several studies (61). The overall test–retest reliability coefficients were high for each domain of the FSFI (r ranging from 0.73 to 0.86) and the internal consistencies within the acceptable range (α ranging from 0.72 to 0.90).	The total score is the sum of the scores in all domains. Items 1, 2, 15, 16 are ranking Likert scale from 1-5 and other questions rating Likert scale from 0-5. The maximum score is 36, and scores lower than 28 reveal an undesirable sexual function		Including 6 dimensions (desire, arousal, lubrication, orgasm, satisfaction and pain.)	This instrument consists of 19 questions that evaluate the sexual function in women over the past 4 weeks.	Iranian version of FSFI (79, 80)
Iranian version of BICI is validated by Pooravari et al. (Cronbach's α = 0.91)(62).	Questions rating on a 5 point Likert scale from 1(never) to 5 (always). Total score can range from 19-95, which the lower scores indicate satisfaction body image	BICI consists of 19 questions		self-report questionnaire which assessing dissatisfaction and shame regarding one’s appearance	Iranian version of BICI (81)
Snyder’s Adult Hope Scale (AHS) can be used as a valid and reliable instrument for assessing hope in women with breast cancer (63)	The scoring is based on 8-point Likert scale including 1 (Definitely False), 2 (Mostly False), 3 (Somewhat False), 4 (Slightly False), 5 (Slightly True), 6 (Somewhat True), 7 (Mostly True) and 8 (Definitely True).	Consist of 12 questions with four items measure pathways of thinking, four items measure agency thinking and other four items are expletive.		Instrument consists of 12 questions measuring hope in the general adult population.	Iranian version of AHS(82)
validity and reliability of Iranian version of IPAQ is confirmed with Cronbach's Alpha coefficient (0.7) and Spearman Brown correlation coefficient (0.9) (64)	Results reported in 3 categories low activity, medium activity and high activity level	5 sections: occupational (7 items), transportation (6 items), household affaires (6 items), leisure-time activities (6 items) and time spent on sitting (2 items)		Scale with 27 items as a long form questionnaire assessing physical activity during the past 7 days	Iranian version of IPAQ (83)

QoL; Quality of life, EORTC QLQ-C30: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, EORTC QLQ-BR23: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer-Specific, SF-36: The Short Form 36 Health Survey Questionnaire, FACT-B : Functional Assessment of Cancer Therapy-Breast, HADS: The Hospital Anxiety and Depression Scale, BDI : beck depression inventory, Brums-32: Brunel mood scale-32 items, FSFI : Female Sexual Function Index, BICI : Body Image Concern Inventory, AHS: Adult Hope Scale, IPAQ: International Physical Activity Questionnaire

No competing interests reported.

A prospective, multicenter, cohort study to evaluate the long-term quality of life and psychological factors among patients with breast cancer, 5-year follow-up: a study protocol

Status:

Version 2

Abstract

Figures

Background

Methods

Discussion

Abbreviations

Declarations

References

Table 1

Additional Declarations

Status:

Version 2