An interventional study of Cognitive-existential intervention and Usual care in Non-metastatic Cancer and Adjustment Disorder, sponsored by CHU de Quebec-Universite Laval. Status unknown at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Supportive care
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.
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.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's planned enrollment of 513 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this group receive the usual treatment only.
Other: Usual care
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
Other: 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.
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.
This group receive the usual treatment only.
Existential quality of life
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).
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)
Global quality of life
To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
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)
The record gives a start of Feb 2009, a primary completion of Dec 2013 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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