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

Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)

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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Study Overview

• Status: Completed
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Behavioral: Mindfulness open and circular program

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility	Patient participation rate and number of sessions performed per patient	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved patient well-being	Hospital Anxiety et Depression Scale (HADS) and Quality of Life Questionnaire C30 (QLQC30) and QLQ -FA12 (EORTC Cancer Related Fatigue)	3 months
Measure patient satisfaction	Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]	3 months
Measure care staff satisfaction	Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]	3 months

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: François Bourgognon, PhD, Institut de Cancerologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Quality of life; Mindfulness; Meditation; Open and circular program
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2020-A03205-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No