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NCT Number: NCT04751201

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 3 months

    Patient participation rate and number of sessions performed per patient

Secondary outcomes

  1. Improved patient well-being

    Time frame: 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

    Time frame: 3 months

    Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

  3. Measure care staff satisfaction

    Time frame: 3 months

    Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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