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Breast CancerCOMPLIANCENCT04176809

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

A study testing Routine Assessment of HRQoL coupled with Therapeutic Information in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Routine Assessment of HRQoL coupled with Therapeutic Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
1 siteFrance
Study dates
14 May 2021to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Sandrine DABAKUYO, PhD, HDR contact

0345348067 ext. +33

sdabakuyo@cgfl.fr

Ariane MAMGUEM KAMGA, PhD contact

0345348069 ext. +33

amamguem@cgfl.fr

France1 site, 1 recruiting

  • Centre Georges François Leclerc

    Dijon

    Sandrine DABAKUYO, PhD,HDR, sdabakuyo@cgfl.fr

    Ariane MAMGUEM KAMGA, PhD, amamguem@cgfl.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Routine Assessment of HRQoL coupled with Therapeutic Information
Keywords
Health Related Quality of Life, Compliance, Endocrine Therapy, Therapeutic Information
Medical subject headings
Breast Neoplasms, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine Assessment of HRQoL coupled with Therapeutic InformationOther

    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.

Study groups in NCT04176809
Study groupRoleWhat they receive
Interventional armExperimentalThe 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.
Receives: Other: Routine Assessment of HRQoL coupled with Therapeutic Information
Control armNo interventionParticipants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants compliant with endocrine therapy as assessed by Morisky Green Levine (MGL) scale

    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.

    Measured: 12 months after the onset of endocrine therapy

Secondary outcomes (5)

  1. Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: at baseline and 12 months after the onset of endocrine therapy

  2. social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)

    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

    Measured: at baseline and 12 months after the onset of endocrine therapy

  3. HRQoL data using Functional Assessment Cancer Therapy-General questionnaire (FACT-G)

    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.

    Measured: at baseline and 12 months after the onset of endocrine therapy

  4. 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)

    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.

    Measured: at baseline and 12 months after the onset of endocrine therapy

  5. Physician perception regarding the utility of systematic HRQoL evaluation as assessed by an ad-hoc questionnaire

    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.

    Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start14 May 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
342 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176809
Sponsor's protocol ID
2019-A01323-54
Acronym
COMPLIANCE
Status last verified
May 2021
First submitted
20 Nov 2019
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huiart L, Bardou VJ, Giorgi R. [The importance of adherence to oral therapies in the field of oncology: the example of breast cancer]. Bull Cancer. 2013 Oct;100(10):1007-15. doi: 10.1684/bdc.2013.1830. French.

    PubMed 24113516

  • Ayres LR, Baldoni Ade O, Borges AP, Pereira LR. Adherence and discontinuation of oral hormonal therapy in patients with hormone receptor positive breast cancer. Int J Clin Pharm. 2014 Feb;36(1):45-54. doi: 10.1007/s11096-013-9833-5. Epub 2013 Aug 11.

    PubMed 23934310

  • Hugtenburg JG, Timmers L, Elders PJ, Vervloet M, van Dijk L. Definitions, variants, and causes of nonadherence with medication: a challenge for tailored interventions. Patient Prefer Adherence. 2013 Jul 10;7:675-82. doi: 10.2147/PPA.S29549. Print 2013.

    PubMed 23874088

  • Egede LE, Gebregziabher M, Dismuke CE, Lynch CP, Axon RN, Zhao Y, Mauldin PD. Medication nonadherence in diabetes: longitudinal effects on costs and potential cost savings from improvement. Diabetes Care. 2012 Dec;35(12):2533-9. doi: 10.2337/dc12-0572. Epub 2012 Aug 21.

    PubMed 22912429

  • 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.

    PubMed 26070268

  • 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.

    PubMed 22689091

  • 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.

    PubMed 22314001

  • 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.

    PubMed 24586261

  • Taketani K, Tokunaga E, Yamashita N, Tanaka K, Akiyoshi S, Okada S, Ando K, Kimura Y, Saeki H, Oki E, Morita M, Kusumoto T, Maehara Y. Early discontinuation of adjuvant hormone therapy is associated with a poor prognosis in Japanese breast cancer patients. Surg Today. 2014 Oct;44(10):1841-6. doi: 10.1007/s00595-013-0762-7. Epub 2013 Oct 19.

    PubMed 24142101

  • Hadji P, Blettner M, Harbeck N, Jackisch C, Luck HJ, Windemuth-Kieselbach C, Zaun S, Kreienberg R. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer. Ann Oncol. 2013 Jun;24(6):1505-12. doi: 10.1093/annonc/mds653. Epub 2013 Feb 1.

    PubMed 23378537

  • Ziller V, Kyvernitakis I, Knoll D, Storch A, Hars O, Hadji P. Influence of a patient information program on adherence and persistence with an aromatase inhibitor in breast cancer treatment--the COMPAS study. BMC Cancer. 2013 Sep 4;13:407. doi: 10.1186/1471-2407-13-407.

    PubMed 24006873

  • Markopoulos C, Neven P, Tanner M, Marty M, Kreienberg R, Atkins L, Franquet A, Gnant M, Neciosup S, Tesarova P, Barni S, Deschamp V. Does patient education work in breast cancer? Final results from the global CARIATIDE study. Future Oncol. 2015;11(2):205-17. doi: 10.2217/fon.14.179.

    PubMed 25591836

  • 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.

    PubMed 19299162

  • Madan A, Borckardt JJ, Connell A, Book SB, Campbell S, Gwynette MF, Wimberly LA, Wagner M, Weinstein B, McLeod-Bryant S, Cooney H, Herbert J. Routine assessment of patient-reported outcomes in behavioral health: room for improvement. Qual Manag Health Care. 2010 Jan-Mar;19(1):70-81. doi: 10.1097/QMH.0b013e3181ccbc53.

    PubMed 20042935

  • 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.

    PubMed 21172892

Questions about this trial

What is this clinical trial studying?

A study testing Routine Assessment of HRQoL coupled with Therapeutic Information in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sandrine DABAKUYO, PhD, HDR (0345348067 ext. +33, sdabakuyo@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04176809, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.

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