Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer (COMPLIANCE)

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ClinicalTrials.gov Identifier: NCT04176809

Recruitment Status : Recruiting

First Posted : November 25, 2019

Last Update Posted : June 1, 2021

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Sponsor:

Information provided by (Responsible Party):

Centre Georges Francois Leclerc

Study Description

Brief Summary:

Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: Routine Assessment of HRQoL coupled with Therapeutic Information	Not Applicable

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Detailed Description:

In this study, 342 women with non-metastatic hormone receptor positive breast cancer with an indication for treatment with endocrine therapy will be include. Participants will be recruited at Dijon cancer center (Georges Francois Leclerc- center) in France. This center is specialized in cancer management, therefore clinicians are experienced in patient's HRQoL evaluation and are accustomed to take this criterion into consideration in the routine patient management. The study will be proposed to eligible participants by their doctors (oncologists, surgeons, radiation oncologists). Participants will be included at the time of the first prescription of ET (at the end of the treatments by surgery +/- chemotherapy +/- radiotherapy). Once included, participants will be randomized (ratio 1:1) by minimization and stratified by: age, stage, type of ET prescribed and presence or not of comorbidities, in 2 arms. Participants will then be referred to the clinical research associates, whose role will be to collect participant data (clinical and sociodemographic) in both study arms and to instruct participants in the interventional arm on how to use the Computer-based Health Evaluation System (CHES) software. For participants who wish to access the platform from home, a login and password will also be provided. If needed, clinical research associates will also assist participants to complete HRQoL questionnaires. This information will be collected in the case report form, to take into account the social desirability bias. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. HRQoL assessment will be performed at each visit. As the aim of this project is to integrate this intervention in daily clinical practice, it will be performed in agreement with patients' routine follow-up. Participants will complete the questionnaires prior to each consultation, either at home via access to the web portal within 24 hours before consultation, or at the time of consultation. During consultation physician will have access to the results immediately, via the secure web portal, and will be able to discuss them with the participant. Therapeutic information will consist on 3 workshops. Workshop 1, entitled "Understanding the Prescription" will provide information on ET and its benefits. Two additional optional workshops on nutrition and fatigue will also be offered. Every month, a letter encouraging participants to regularly take their medication will be sent. Participants in the control group will follow standard care. Both in two arms, HRQoL will be evaluated at baseline using the FACT-G questionnaire to ensure the comparability of groups concerning HRQoL at inclusion, and again at 12 months. HRQoL assessment will be performed using a traditional paper questionnaire and scores will not be provided to clinicians. Anxiety and depression, social support and participant satisfaction with care will also be assessed in both arms at baseline and 12 months after. Sociodemographic characteristics, medical and surgical history, date of tumor diagnosis, tumor characteristics, previous treatments, participant clinical characteristics at inclusion and at each follow-up visit (weight, height, overall patient condition), concomitant treatment, type of ET received, HRQoL data (FACT-G), anxiety and depression (HADS), social support (SSQ6), treatment modification (change in the type of ET), treatment-related toxicities and their grade will be collected. Participant satisfaction with provided care will be measured. Clinicians' perceptions of systematic HRQoL assessment will be collected via an ad hoc questionnaire. Sociodemographic data and reasons for refusing to participate will also be documented for patients who refuse to participate. Data on patients' withdrawal or death will be documented in the case report form. Reasons for study withdrawal should also be documented. All data from this study will be transcribed in an electronic case report form. A descriptive analysis of participants' clinical and socio-demographic characteristics at inclusion will be performed for each arm. All HRQoL scores will be calculated according to FACT-G guidelines and described according to the arm (interventional arm or control arm). A logistic regression model will be used to assess the capacity of HRQoL to predict 12-month compliance with endocrine therapy. The modulatory potential of social support on compliance will be assessed using an interaction term between the availability / satisfaction of social support that patients receive and HRQoL in a logistic regression model. The modulatory potential of psychological distress on compliance will be assessed using an interaction term between patient anxiety / depression and HRQoL in a logistic regression model.

An analysis of missing HRQoL data profiles will also be performed. If a Missing Not At Random (MNAR) profile is demonstrated / suspected, multiple imputation of missing data can be performed in sensitivity analysis, taking into account the variables associated with the occurrence of missing data. As a sensitivity analysis, the investigators will performed a contamination-based intent-to-treat analysis to account for potential cross-contamination between the arms.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	342 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Eligible patients who agree to participate will be randomized into two parallel arms (ratio 1:1) by the minimization technique with stratification by age, stage, presence or absence of comorbidities and type of endocrine therapy prescribed
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Impact of Routine Assessment of Health-Related Quality of Life Coupled With Therapeutic Information on Compliance With Endocrine Therapy in Patients With Non-metastatic Breast Cancer
Actual Study Start Date :	May 14, 2021
Estimated Primary Completion Date :	April 2025
Estimated Study Completion Date :	October 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Interventional arm The intervention will consist in an electronic measurement of HRQoL before each consultation with delivery scores to clinicians, who can discuss it with patients and coupled with therapeutic information. Patients will complete the EORTC-Quality of Life Questionnaire (QLQ)-C30 and the EORTC-QLQ-Breast (BR) 23 questionnaires using the CHES software before their consultation, via a touch pad or from their home via a secure web portal. Therapeutic information will consist on workshops on various themes. Only attendance Workshop 1 will be required, other workshops will be optional. The aim of workshop 1 is to inform patients about their ET and treatment benefits. Two additional optional workshops on nutrition (Workshop 2) and fatigue (Workshop 3) will be offered. This workshops will be collective. Every month, a letter encouraging patients to regularly take their medication will be sent. This letter will also include some tips on how to deal with some particular side effects of ET.	Other: Routine Assessment of HRQoL coupled with Therapeutic Information Participants will complete the EORTC-QLQ-C30 and EORTC-QLQ-BR23 questionnaires before their consultation via the CHES software. The scores will then be generated and provided to clinicians in a graphic form, describing scores course. Access to CHES web portal will also be open to participants outside consultation time points, to enable them to monitor HRQoL if necessary. Workshop 1, will help patients to recognize and react to the occurrence of possible adverse effects, and anticipate their occurrence through appropriate preventive means. In workshop 2, participants will have the opportunity to express their representations and experiences related to their diet and the consequences of disease and treatments on diet. In workshop 3, participants can describe their experiences of fatigue and how their life is affected by it. Moreover, they can identify possible causes and finally discuss solutions to better this symptom. Every month, a reminder letter will also be sent to participants.
No Intervention: Control arm Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.

Arm

Intervention/treatment

Experimental: Interventional arm

The intervention will consist in an electronic measurement of HRQoL before each consultation with delivery scores to clinicians, who can discuss it with patients and coupled with therapeutic information. Patients will complete the EORTC-Quality of Life Questionnaire (QLQ)-C30 and the EORTC-QLQ-Breast (BR) 23 questionnaires using the CHES software before their consultation, via a touch pad or from their home via a secure web portal. Therapeutic information will consist on workshops on various themes. Only attendance Workshop 1 will be required, other workshops will be optional. The aim of workshop 1 is to inform patients about their ET and treatment benefits. Two additional optional workshops on nutrition (Workshop 2) and fatigue (Workshop 3) will be offered. This workshops will be collective. Every month, a letter encouraging patients to regularly take their medication will be sent. This letter will also include some tips on how to deal with some particular side effects of ET.

Other: Routine Assessment of HRQoL coupled with Therapeutic Information

Participants will complete the EORTC-QLQ-C30 and EORTC-QLQ-BR23 questionnaires before their consultation via the CHES software. The scores will then be generated and provided to clinicians in a graphic form, describing scores course. Access to CHES web portal will also be open to participants outside consultation time points, to enable them to monitor HRQoL if necessary. Workshop 1, will help patients to recognize and react to the occurrence of possible adverse effects, and anticipate their occurrence through appropriate preventive means. In workshop 2, participants will have the opportunity to express their representations and experiences related to their diet and the consequences of disease and treatments on diet. In workshop 3, participants can describe their experiences of fatigue and how their life is affected by it. Moreover, they can identify possible causes and finally discuss solutions to better this symptom. Every month, a reminder letter will also be sent to participants.

No Intervention: Control arm

Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.

Outcome Measures

Primary Outcome Measures :

Number of participants compliant with endocrine therapy as assessed by Morisky Green Levine (MGL) scale [ Time Frame: 12 months after the onset of endocrine therapy ]
Compliance with endocrine therapy, will be evaluated using the Morisky Green Levine scale (MGL). It has a range of 0 to 4, where 0 is very low and 4 is highest. Patients are categorized according to three levels of adherence: high (score equal to 4), moderate (score equal to 2 or 3) and low (score equal to 0 or 1). Participants will be considered as compliant if they have a high adherence score in MGL scale.

Secondary Outcome Measures :

Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: at baseline and 12 months after the onset of endocrine therapy ]
HADS has 14 items rated from 0 to 3 and covers 2 dimensions. Seven questions related to the anxiety dimension and seven other related to the depressive dimension, yielding 2 scores, A (Anxiety) and D (Depression). The maximum score for each dimension is 21. A score of 11 or higher indicates the probable presence of the disorder.
social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6) [ Time Frame: at baseline and 12 months after the onset of endocrine therapy ]
Social support is measured across 2 dimensions: support availability, through the number of contacts that the patient can count on (0 to 9 people) and quality of support, through patient satisfaction with support received.

Each item represents a situation in which the patient may need support. Patient is asked to cite the number of people that she could count on in that particular situation. Concerning the second item, the patient is asked to assess satisfaction with the support provided. The scores are generated according to Sarason's recommendations. A score is calculated for each dimension. Support availability score is calculated as the sum of the number of people available for the 6 items, this score ranges from 0 to 54, with 54 representing the highest availability. The social support satisfaction score is calculated by the sum of the satisfaction of the 6 items. This score ranges from 6 to 36, with 36 representing the highest level of satisfaction
HRQoL data using Functional Assessment Cancer Therapy-General questionnaire (FACT-G) [ Time Frame: at baseline and 12 months after the onset of endocrine therapy ]
HRQoL data using the Functional Assessment Cancer Therapy General (FACT-G) questionnaire will be assessed at inclusion in both arms to ensure comparability between groups and at 12 months, to assess the predictive value of HRQoL on compliance to endocrine therapy. The FACT-G instrument assesses 4 HRQoL domains: physical well-being (7 items); social and/or family well-being (7 items); emotional well-being (6 items); and functional well-being (7 items). Respondents use a 5-point Likert-type scale which rates the relevant domain from 0 (not at all) to 4 (very much). From these subscales a global score is obtained. The FACT-G total score vary from 0 to 108. The higher the score, the better the HRQoL.
Patient satisfaction with care as assessed by European Organization Research and Treatment Cancer 33-item Satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and its module 7-item Outpatient Satisfaction with care (EORTC OUT-PATSAT-7) [ Time Frame: at baseline and 12 months after the onset of endocrine therapy ]
The European Organization Research and Treatment Cancer 33-item Satisfaction with cancer care core (EORTC PATSAT-C33) questionnaire and its module 7-item Outpatient Satisfaction with care (EORTC OUT-PATSAT-7) assess perceptions of cancer patients regarding the quality of care received. The EORTC PATSAT-C33 includes 3 sections on the perceived quality of care provided by physicians, radiotherapy nurses/technicians and services/care organization. The first one includes 3 dimensions that address technical skills, quality and quantity of information exchanged and behavior. The second one has 2 dimensions: information provision and reactivity and affective behavior. The third one has 3 dimensions: coordination, interaction with the healthcare team and 5 single items. The module EORTC-OUT-PATSAT7 includes 2 dimensions dealing with convenience of care and transition and a single item on continuity of care. The score vary from 0 to 100. A higher score indicates higher level of satisfaction.
Physician perception regarding the utility of systematic HRQoL evaluation as assessed by an ad-hoc questionnaire [ Time Frame: through study completion, an average of 3 years ]
Physician perception regarding the utility of systematic HRQoL evaluation will be assessed using an ad hoc questionnaire derived from the work of Velikova, including the perceived utility and satisfaction of routine assessment HRQoL, reasons for use/non-use and the intention to adopt this assessment in routine care. This questionnaire does not generate a score but give us information on the points mention above.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women aged 18 and over
With non-metastatic hormone receptor positive breast cancer
Women will have to be at the end of primary treatment
An indication for endocrine therapy treatment during 5 to 10 years
be affiliated to a French social security scheme or beneficiary of such a scheme
agreed to participate by signing a written consent

Exclusion Criteria:

Participants who participate in another clinical trial where HRQoL is assessed
Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.).
Vulnerable participants (pregnant women, etc.)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176809

Contacts

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Contact: Sandrine DABAKUYO, PhD, HDR	0345348067 ext +33	sdabakuyo@cgfl.fr
Contact: Ariane MAMGUEM KAMGA, PhD	0345348069 ext +33	amamguem@cgfl.fr

Locations

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France
Centre Georges François Leclerc	Recruiting
Dijon, France
Contact: Sandrine DABAKUYO, PhD,HDR sdabakuyo@cgfl.fr
Contact: Ariane MAMGUEM KAMGA, PhD amamguem@cgfl.fr

Sponsors and Collaborators

Centre Georges Francois Leclerc

Investigators

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Principal Investigator:	Isabelle DESMOULINS, MD	Georges François Leclerc Centre

More Information

Publications:

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Cheung WY, Lai EC, Ruan JY, Chang JT, Setoguchi S. Comparative adherence to oral hormonal agents in older women with breast cancer. Breast Cancer Res Treat. 2015 Jul;152(2):419-27. doi: 10.1007/s10549-015-3455-7. Epub 2015 Jun 13.

Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012 Jul;134(2):459-78. doi: 10.1007/s10549-012-2114-5. Epub 2012 Jun 12.

Weaver KE, Camacho F, Hwang W, Anderson R, Kimmick G. Adherence to adjuvant hormonal therapy and its relationship to breast cancer recurrence and survival among low-income women. Am J Clin Oncol. 2013 Apr;36(2):181-7. doi: 10.1097/COC.0b013e3182436ec1.

Hsieh KP, Chen LC, Cheung KL, Chang CS, Yang YH. Interruption and non-adherence to long-term adjuvant hormone therapy is associated with adverse survival outcome of breast cancer women--an Asian population-based study. PLoS One. 2014 Feb 21;9(2):e87027. doi: 10.1371/journal.pone.0087027. eCollection 2014.

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Hadji P. Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. Crit Rev Oncol Hematol. 2010 Feb;73(2):156-66. doi: 10.1016/j.critrevonc.2009.02.001. Epub 2009 Mar 18.

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Epplein M, Zheng Y, Zheng W, Chen Z, Gu K, Penson D, Lu W, Shu XO. Quality of life after breast cancer diagnosis and survival. J Clin Oncol. 2011 Feb 1;29(4):406-12. doi: 10.1200/JCO.2010.30.6951. Epub 2010 Dec 20.

Takada K, Kashiwagi S, Fukui Y, Goto W, Asano Y, Morisaki T, Takashima T, Hirakawa K, Ohira M. Prognostic value of quality-of-life scores in patients with breast cancer undergoing preoperative chemotherapy. BJS Open. 2018 Nov 26;3(1):38-47. doi: 10.1002/bjs5.50108. eCollection 2019 Feb.

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Pinheiro LC, Wheeler SB, Reeder-Hayes KE, Samuel CA, Olshan AF, Reeve BB. Investigating Associations Between Health-Related Quality of Life and Endocrine Therapy Underuse in Women With Early-Stage Breast Cancer. J Oncol Pract. 2017 May;13(5):e463-e473. doi: 10.1200/JOP.2016.018630. Epub 2017 Mar 14.

Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7.

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Bredart A, Anota A, Young T, Tomaszewski KA, Arraras JI, Moura De Albuquerque Melo H, Schmidt H, Friend E, Bergenmar M, Costantini A, Vassiliou V, Hureaux J, Marchal F, Tomaszewska IM, Chie WC, Ramage J, Beaudeau A, Conroy T, Bleiker E, Kulis D, Bonnetain F, Aaronson NK; EORTC Quality of Life Group. Phase III study of the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and specific complementary outpatient module (EORTC OUT-PATSAT7). Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12786. Epub 2017 Nov 2.

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Velikova G, Keding A, Harley C, Cocks K, Booth L, Smith AB, Wright P, Selby PJ, Brown JM. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer. 2010 Sep;46(13):2381-8. doi: 10.1016/j.ejca.2010.04.030. Epub 2010 Jun 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mamguem Kamga A, Di Martino C, Anota A, Paget-Bailly S, Coutant C, Arveux P, Desmoulins I, Dabakuyo-Yonli TS. Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial. Trials. 2020 Jun 16;21(1):527. doi: 10.1186/s13063-020-04397-w.

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Responsible Party:	Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:	NCT04176809
Other Study ID Numbers:	2019-A01323-54
First Posted:	November 25, 2019 Key Record Dates
Last Update Posted:	June 1, 2021
Last Verified:	May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Centre Georges Francois Leclerc:


Health Related Quality of Life Compliance Endocrine Therapy Therapeutic Information

Additional relevant MeSH terms:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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