Clinical Trial: Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life

Brief Summary: The purpose of this study is to test the efficacy of a cognitive-existential intervention (using either an individual or a group format) to improve the existential and global quality of life of patients as compared to usual care in a population of adult non-metastatic cancer patients.

Detailed Summary:

People diagnosed with cancer must learn to cope with loss of meaning and empowerment which compromises quality of life. Questions regarding "Why me?", along with universal existential concerns about death, search for meaning, and sense of control over one's life, often constitute the principal source of overall suffering. Since there is no single and identifiable cause for cancer, those existential questions are commonly observed among patients who demand specific interventions to properly address this central issue. The existential approach can be used to help patients find meaning in the midst of a crisis. It addresses a central issue of survivorship in cancer.

The conceptual model explains the relation between being exposed to a stressful and traumatic life event such as cancer and the risk of progressing toward adjustment difficulties which compromises quality of life and existential integrity. Cancer constitutes a major stressor involving significant losses that confronts the person's beliefs system. A set of therapeutic strategies can help to cope with this inevitable challenge: 1) cognitive-behavioral strategies; 2) direct existential intervention; and 3) social support through supportive-expressive strategies. Adjustment first involves cognitive reframing of the perception of the situation (situational meaning). Cognitive reframing also contributes to a readjustment of personal beliefs and values (global meaning and existential dimension). Existential strategies enable to further this process by including cognitive (beliefs, sense of coherence, expectations), motivational (choice, goal setting, and goal driving) and affective dimensions. The expressive-supportive strategy promotes active listening and non-judgmental support to encourage expression of emotions. The use of these active coping strategies (meaning-based) to the threatened-life challenge enab
Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec

Current Primary Outcome:

  • Existential quality of life [ Time Frame: T0: Pre-intervention ]

    At every time frame, we use two questionnaires to measure the primary outcome:

    1. The McGill Quality of Life Questionnaire (MQOL): 16 items plus a single-item global scale.
    2. Spiritual well-being (FACIT-SP): The FACIT-SP is a sub-scale of the FACT-G (Functional Assessment of Cancer Therapy-General) and a French version of the "FACIT-SP, FACIT-Spiritual well-being scale". This questionnaire has two sub-scales: Meaning/Peace (8 items) and Faith (4 items).
  • Existential quality of life [ Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention) ]
  • Existential quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ]
  • Existential quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ]
  • Existential quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ]
  • Existential quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Global quality of life [ Time Frame: T0: Pre-intervention ]
    To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
  • Global quality of life [ Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention) ]
  • Global quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ]
  • Global quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ]
  • Global quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ]
  • Global quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Québec, CHU de Québec

Dates:
Date Received: June 9, 2010
Date Started: February 2009
Date Completion: April 2015
Last Updated: February 2, 2015
Last Verified: February 2015