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

Adjustment Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01141933
• Other study ID #: CSS-019126
• Status: Active, not recruiting
• Phase: N/A
• First received: June 9, 2010
• Last updated: March 2, 2018
• Start date: February 2009
• Est. completion date: August 2018

Study information

• Verified date: March 2018
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 513
• Est. completion date: August 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders
• Non-metastatic Cancer

Intervention

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.
• Usual care
This group receive the usual treatment only.

Locations

Country	Name	City	State
Canada	Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	McGill University	Montreal	Quebec
Canada	CHU de Québec - Université Laval	Quebec
Canada	CHU de Québec - Université Laval	Québec
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (5)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Cancer Society Research Institute (CCSRI), Centre de recherche en cancérologie de l'Université Laval, Laval University, Maison Michel-Sarrazin

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existential quality of life	At every time frame, we use two questionnaires to measure the primary outcome: The McGill Quality of Life Questionnaire (MQOL): 16 items plus a single-item global scale.; 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).	T0: Pre-intervention
Primary	Existential quality of life		T1: Mid-intervention (6 weeks after the beginning of the intervention)
Primary	Existential quality of life		T2: End of the intervention (12 weeks after the beginning of the intervention)
Primary	Existential quality of life		T3: First follow-up measure (3 months after the end of the intervention)
Primary	Existential quality of life		T4: Second follow-up measure (6 months after the end of the intervention)
Primary	Existential quality of life		T5: Last follow-up measure (12 months after the end of the intervention)
Secondary	Global quality of life	To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.	T0: Pre-intervention
Secondary	Global quality of life		T1: Mid-intervention (6 weeks after the beginning of the intervention)
Secondary	Global quality of life		T2: End of the intervention (12 weeks after the beginning of the intervention)
Secondary	Global quality of life		T3: First follow-up measure (3 months after the end of the intervention)
Secondary	Global quality of life		T4: Second follow-up measure (6 months after the end of the intervention)
Secondary	Global quality of life		T5: Last follow-up measure (12 months after the end of the intervention)

External Links

•   Canadian Cancer Society - Dr Pierre Gagnon
•   Laval University Cancer Research center - Dr Pierre Gagnon
•   Website of research team