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

NCT04751201 | Completed

• 1 other identifier: 2020-A03205-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Mindfulness; Quality of life; Cancer; Open and circular program; Meditation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improved patient well-being

  3 months

• Measure patient satisfaction

  3 months

• Measure care staff satisfaction

  3 months

Study Arms (1)

Receiving mindfulness open and circular program

EXPERIMENTAL

Behavioral: Mindfulness open and circular program

Interventions

Mindfulness open and circular program 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

Receiving mindfulness open and circular program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• 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.

  PMID: 39021646 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• François Bourgognon, PhD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 12, 2021
• Study Start: September 1, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

FR (1)