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

Primary Purpose

Breast Cancer, Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Mindfulness open and circular program

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Mindfulness, Quality of life, Cancer, Open and circular program, Meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Receiving mindfulness open and circular program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improved patient well-being

Hospital Anxiety et Depression Scale (HADS) and Quality of Life Questionnaire C30 (QLQC30) and QLQ -FA12 (EORTC Cancer Related Fatigue)

Measure patient satisfaction

Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

Measure care staff satisfaction

Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

Full Information

NCT ID

NCT04751201

First Posted

February 4, 2021

Last Updated

August 3, 2023

Sponsor

Institut de Cancérologie de Lorraine

1. Study Identification

Unique Protocol Identification Number

NCT04751201

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

July 13, 2022 (Actual)

Study Completion Date

July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Receiving mindfulness open and circular program

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness open and circular program

Intervention Description

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

Primary Outcome Measure Information:

Title

Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility

Description

Patient participation rate and number of sessions performed per patient

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Improved patient well-being

Description

Hospital Anxiety et Depression Scale (HADS) and Quality of Life Questionnaire C30 (QLQC30) and QLQ -FA12 (EORTC Cancer Related Fatigue)

Time Frame

3 months

Title

Measure patient satisfaction

Description

Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

Time Frame

3 months

Title

Measure care staff satisfaction

Description

Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

François Bourgognon, PhD

Organizational Affiliation

Institut de Cancérologie de Lorraine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cancerologie de Lorraine

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

54519

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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