Overview

This trial is active, not recruiting.

Conditions non-metastatic cancer, adjustment disorder
Treatments cognitive-existential intervention, usual care
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator Laval University
Start date February 2009
End date December 2013
Trial size 513 participants
Trial identifier NCT01141933, CSS-019126

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Subjects in this group receive the usual treatment only.
usual care
This group receive the usual treatment only.
(Experimental)
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
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)
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.
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.

Primary Outcomes

Measure
Existential quality of life
time frame: T0: Pre-intervention
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)

Secondary Outcomes

Measure
Global quality of life
time frame: T0: Pre-intervention
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life
Principal investigator Pierre Gagnon, MD, FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.