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

NCT ID: NCT04751201

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-07-13

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.

.

Conditions

Breast Cancer; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Receiving mindfulness open and circular program

Group Type: EXPERIMENTAL

Mindfulness open and circular program

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Bourgognon, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

References

Bourgognon F, Bechet D, Huin-Schohn C, Strelow A, Demarche L, Guillou M, Adam V, Fall E, Omorou AY. A mixed method feasibility and acceptability study of a flexible intervention based on acceptance and commitment therapy for patients with cancer. Front Psychol. 2024 Jul 3;15:1409308. doi: 10.3389/fpsyg.2024.1409308. eCollection 2024.

Reference Type: DERIVED

PMID: 39021646 (View on PubMed)

Other Identifiers

2020-A03205-34

Identifier Type: -

Identifier Source: org_study_id