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Meditation and Cancer, Pilot Feasibility Study (MAEva Pilot Study)

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: NCT04751201
Recruitment Status : Not yet recruiting
First Posted : February 12, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Study Description
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Brief Summary:

MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.

This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.

Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.

The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.

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Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Behavioral: Mindfulness open and circular program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Receiving mindfulness open and circular program Behavioral: Mindfulness open and circular program

At the end of the first and the last cycle, as well as 3 weeks after the last cycle, the patient will be invited to answer different questionnaires evaluating his or her quality of life (HADS, QLQC30, FA12). This is why the observation period is 3 months (3 cycles of 3 weeks + 3 weeks).

Similarly, some of the patients included in the study will be asked to complete a semi-structured interview at the end of the MAEva programme.

Patients and nursing staff participating in the study will be asked to complete a satisfaction questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility [ Time Frame: 3 months ]
    Patient participation rate and number of sessions performed per patient


Secondary Outcome Measures :
  1. Improved patient well-being [ Time Frame: 3 months ]
    Hospital Anxiety et Depression Scale (HADS) and Quality of Life Questionnaire C30 (QLQC30) and QLQ -FA12 (EORTC Cancer Related Fatigue)

  2. Measure patient satisfaction [ Time Frame: 3 months ]
    Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

  3. Measure care staff satisfaction [ Time Frame: 3 months ]
    Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]


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

Inclusion Criteria:

  • Major patient
  • Patient with non-metastatic prostate or breast cancer
  • Newly diagnosed patients or those undergoing treatment
  • Patient able and willing to follow all study procedures in accordance with the protocol.
  • Patient having understood, signed and dated the consent form.
  • Patient affiliated to the social security system
  • Patient able to remain in a sitting position during the 2-hour session

Exclusion Criteria:

  • Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
  • Presence of an acute psychiatric disorder: depression in acute phase, unstabilised bipolar disorder, psychotic disorders (delusions, hallucinations), etc.
  • Presence of recurrent uncontrolled panic attacks (notably linked to hypochondriac concerns)
  • Presence of latent or patent post-traumatic stress disorder
  • Lack of motivation to meditate
  • Insufficient attentional resources to meditate: major problems with attention, memory or reasoning
  • Patient with metastatic cancer.
  • Presence of cognitive and neurocognitive disorders and deficits
  • Presence of deafness
  • Membership in a meditation programme prior to inclusion
Contacts and Locations
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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): NCT04751201


Contacts
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Contact: François Bourgognon, Ph D +33 3 83 59 84 86 bourgognon@hotmail.fr
Contact: Marie Aude Herman +33 3 83 59 86 68 m.herman@nancy.unicancer.fr

Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: François Bourgognon, PhD Institut de Cancérologie de Lorraine
More Information
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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT04751201    
Other Study ID Numbers: 2020-A03205-34
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021

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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 Institut de Cancérologie de Lorraine:
Mindfulness
Quality of life
Cancer
Open and circular program
Meditation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases