Clinical trial NCT01141933: Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life
Official title: Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-metastatic Cancer
Adjustment Disorder
Keywords: Creating meaning
Therapy
Cancer
Oncology
Existential
Spirituality
Quality of life
QOL
Psycho-oncology
French-canadian
Cognitive therapy
Existentialism
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Laval University
name: Centre de recherche en cancérologie de l'Université Laval
name: Canadian Cancer Society (CCS)
name: Maison Michel-Sarrazin
First posted: 2010-06-11
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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 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 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) 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).

Primary outcomes:
measure: Existential quality of life
timeFrame: T0: Pre-intervention
measure: Existential quality of life
timeFrame: T1: Mid-intervention (6 weeks after the beginning of the intervention)
measure: Existential quality of life
timeFrame: T2: End of the intervention (12 weeks after the beginning of the intervention)
measure: Existential quality of life
timeFrame: T3: First follow-up measure (3 months after the end of the intervention)
measure: Existential quality of life
timeFrame: T4: Second follow-up measure (6 months after the end of the intervention)
measure: Existential quality of life
timeFrame: T5: Last follow-up measure (12 months after the end of the intervention)
Secondary outcomes:
measure: Global quality of life
timeFrame: T0: Pre-intervention
measure: Global quality of life
timeFrame: T1: Mid-intervention (6 weeks after the beginning of the intervention)
measure: Global quality of life
timeFrame: T2: End of the intervention (12 weeks after the beginning of the intervention)
measure: Global quality of life
timeFrame: T3: First follow-up measure (3 months after the end of the intervention)
measure: Global quality of life
timeFrame: T4: Second follow-up measure (6 months after the end of the intervention)
measure: Global quality of life
timeFrame: T5: Last follow-up measure (12 months after the end of the intervention)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Lévis
country: Canada
facility: Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec - Université Laval
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Laval University
name: Pierre Gagnon, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gagnon, P., Fillion, L., Girard, M.La recherche de sens à la suite d'un diagnostic de cancer: une invervention pour améliorer la qualité de vie existentielle et globale.Les cahiers francophones de soins palliatifs 9 (1): 57-69, 2008.
citation: Gagnon P, Fillion L, Robitaille MA, Girard M, Tardif F, Cochrane JP, Le Moignan Moreau J, Breitbart W. A cognitive-existential intervention to improve existential and global quality of life in cancer patients: A pilot study. Palliat Support Care. 2015 Aug;13(4):981-90. doi: 10.1017/S147895151400073X. Epub 2014 Jul 22.