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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751201
• Other study ID #: 2020-A03205-34
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: August 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Measure patient satisfaction	Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]	3 months
Secondary	Measure care staff satisfaction	Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]	3 months