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

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04751201

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer	Behavioral: Mindfulness open and circular program	N/A

Study Design

Study Type:

Interventional

Anticipated 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)

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility [3 months]
Patient participation rate and number of sessions performed per patient

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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