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

Not Applicable

• Conditions: Non-metastatic Cancer; Adjustment Disorder
• Interventions: Other: Cognitive-existential intervention; Other: Usual care

• Registration Number: NCT01141933
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2013-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 513

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Individual intervention	Cognitive-existential intervention	Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
Group intervention	Cognitive-existential 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.
Usual care	Usual care	Subjects in this group receive the usual treatment only.

Primary Outcome Measures

Name	Time	Method
Existential quality of life	T5: Last follow-up measure (12 months after the end of the intervention)

Secondary Outcome Measures

Name	Time	Method
Global quality of life	T5: Last follow-up measure (12 months after the end of the intervention)

Trial Locations

Locations (5)

McGill University; 🇨🇦 Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Canada

Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis; 🇨🇦 Lévis, Quebec, Canada

CHU de Québec - Université Laval; 🇨🇦 Québec, Canada

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada