We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04176809
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : June 1, 2021
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

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

Show Show detailed description

Layout table for study information
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 related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

  3. 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.

  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) [ 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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.)

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

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

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Isabelle DESMOULINS, MD Georges François Leclerc Centre
Eggersmann TK,Harbeck N, Schinkoethe T, Riese C. eHealth solutions for therapy management in oncology. Breast Cancer Manag. 2018; 6(3):101-106.
Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition).2001.
Bruchon-Schweitzer M. Psychologie de la santé. Modèles, concepts et méthodes. 1er éd. Paris : Dunod. 2002A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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

Layout table for additional information
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
Endocrine Therapy
Therapeutic Information
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases