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)
40
Enrollment
1
Location
1
Arm
15
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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

  1. 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)

  2. Measure patient satisfaction [3 months]

    Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

  3. 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:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institut de Cancerologie de LorraineVandœuvre-lès-NancyFrance54519

Sponsors and Collaborators

  • Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: François Bourgognon, PhD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier:
NCT04751201
Other Study ID Numbers:
  • 2020-A03205-34
First Posted:
Feb 12, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut de Cancérologie de Lorraine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022