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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Laval University
Centre de recherche en cancérologie de l'Université Laval
Canadian Cancer Society Research Institute (CCSRI)
Maison Michel-Sarrazin
Information provided by (Responsible Party):
Pierre Gagnon, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01141933
First received: June 9, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Non-metastatic Cancer
Adjustment Disorder
Other: Cognitive-existential intervention
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Existential quality of life [ Time Frame: T0: Pre-intervention ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
  • Existential quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
  • Existential quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ] [ Designated as safety issue: No ]
  • Existential quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ] [ Designated as safety issue: No ]
  • Existential quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global quality of life [ Time Frame: T0: Pre-intervention ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Global quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
  • Global quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ] [ Designated as safety issue: No ]
  • Global quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ] [ Designated as safety issue: No ]
  • Global quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 513
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual care
Subjects in this group receive the usual treatment only.
Other: Usual care
This group receive the usual treatment only.
Experimental: Individual intervention
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
Other: Cognitive-existential intervention
Over the past 2 years we developed a 12-week cognitive-existential intervention consisting of 12 modules. The first three modules essentially involve cognitive and behavioral techniques proposing reinforcement of the use of active behavioral (e.g., relaxation, activation) and emotional (cognitive reframing) strategies. This content comes from classical cognitive-behavioral techniques. The next 3 modules, inspired by empirically-tested interventions further explore emotional strategies. The last six modules specifically address the existential dimension. They are adapted from logotherapy techniques, which are also empirically-based, and have been adapted to a French-Canadian culture by our team. They aim to improve meaning-based and emotional coping strategies.
Experimental: Group intervention
Consisting in a 12 weekly sessions with two therapists. Number of subjects in each group is from 5 to 10. Each session lasts 2 hours.
Other: Cognitive-existential intervention
Over the past 2 years we developed a 12-week cognitive-existential intervention consisting of 12 modules. The first three modules essentially involve cognitive and behavioral techniques proposing reinforcement of the use of active behavioral (e.g., relaxation, activation) and emotional (cognitive reframing) strategies. This content comes from classical cognitive-behavioral techniques. The next 3 modules, inspired by empirically-tested interventions further explore emotional strategies. The last six modules specifically address the existential dimension. They are adapted from logotherapy techniques, which are also empirically-based, and have been adapted to a French-Canadian culture by our team. They aim to improve meaning-based and emotional coping strategies.

Detailed Description:

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 enables optimization of existential and global quality of life, as opposed to employing passive strategies such as avoidance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be of 18 years of age or more;
  • Speak French;
  • Have received a diagnosis of non-metastatic cancer;
  • Be available to participate in the program of 12 weekly group or individual sessions.

Exclusion Criteria:

  • Depressive mood (score greater than 10 on the Hospital Anxiety and Depression Scale depressive subscale or high psychological distress (HADS overall score above 14) that could interfere with the intervention. Since we specifically target the existential dimension and it might temporarily provoke questioning in patients, high psychological distress must first be addressed using other approaches.
  • Diagnosis of metastatic cancer or diagnosis of non-metastatic cancer with a usually fast-growing and unpredictable course, making it unlikely to adhere to the intervention (e.g., pancreatic cancer, acute leukemia, glioblastoma).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141933

Locations
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Canada, Quebec
Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis
Lévis, Quebec, Canada, G6V 3Z1
McGill University
Montreal, Quebec, Canada, H3A 2T5
Centre hospitalier affilié universitaire de Québec
Québec, Quebec, Canada, G1S 4L8
Centre hospitalier de l'Université Laval
Québec, Quebec, Canada, G1V 4G2
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Canada
Centre hospitalier universitaire de Quebec
Quebec, Canada, G1R2J6
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Laval University
Centre de recherche en cancérologie de l'Université Laval
Canadian Cancer Society Research Institute (CCSRI)
Maison Michel-Sarrazin
Investigators
Principal Investigator: Pierre Gagnon, MD, FRCPC Laval University
  More Information

Additional Information:
No publications provided

Responsible Party: Pierre Gagnon, MD, FRCPC, Psychiatrist, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01141933     History of Changes
Other Study ID Numbers: CSS-019126
Study First Received: June 9, 2010
Last Updated: September 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Creating meaning
Therapy
Cancer
Oncology
Existential
Spirituality
Quality of life
QOL
Psycho-oncology
French-canadian
Quality of Life
Cognitive therapy
Existentialism

Additional relevant MeSH terms:
Adjustment Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014