Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-metastatic Cancer Adjustment Disorder |
Other: Cognitive-existential intervention Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life |
- Existential quality of life [ Time Frame: T0: Pre-intervention ] [ Designated as safety issue: No ]
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).
- Existential quality of life [ Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
- Existential quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
- Existential quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ] [ Designated as safety issue: No ]
- Existential quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ] [ Designated as safety issue: No ]
- Existential quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ] [ Designated as safety issue: No ]
- Global quality of life [ Time Frame: T0: Pre-intervention ] [ Designated as safety issue: No ]To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
- Global quality of life [ Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
- Global quality of life [ Time Frame: T2: End of the intervention (12 weeks after the beginning of the intervention) ] [ Designated as safety issue: No ]
- Global quality of life [ Time Frame: T3: First follow-up measure (3 months after the end of the intervention) ] [ Designated as safety issue: No ]
- Global quality of life [ Time Frame: T4: Second follow-up measure (6 months after the end of the intervention) ] [ Designated as safety issue: No ]
- Global quality of life [ Time Frame: T5: Last follow-up measure (12 months after the end of the intervention) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 513 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Usual care
Subjects in this group receive the usual treatment only.
|
Other: Usual care
This group receive the usual treatment only.
|
|
Experimental: Individual intervention
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
|
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.
|
|
Experimental: Group 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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 or high psychological distress (HADS overall score above 14) 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).
Contacts and Locations| Contact: Laurence Benoit-Bousquet, B.Ed | 418-525-4444 ext 20684 | laurence.bousquet@crhdq.ulaval.ca |
| Contact: Joanie Le Moignan Moreau, M.Sc | 418-525-4444 ext 20693 | joanie.lemoignan@crhdq.ulaval.ca |
| Canada, Manitoba | |
| University of Manitoba | Active, not recruiting |
| Winnipeg, Manitoba, Canada, R3T 2N2 | |
| Canada, Quebec | |
| Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis | Recruiting |
| Lévis, Quebec, Canada, G6V 3Z1 | |
| Sub-Investigator: Félix Couture, MD, FRCPC | |
| McGill University | Active, not recruiting |
| Montreal, Quebec, Canada, H3A 2T5 | |
| Centre hospitalier affilié universitaire de Québec | Recruiting |
| Québec, Quebec, Canada, G1S 4L8 | |
| Sub-Investigator: Louise Provencher, MD, FRCSC | |
| Centre hospitalier de l'Université Laval | Recruiting |
| Québec, Quebec, Canada, G1V 4G2 | |
| Principal Investigator: Pierre Gagnon, MD, FRCPC | |
| Institut universitaire de cardiologie et de pneumologie de Québec | Recruiting |
| Québec, Quebec, Canada, G1V 4G5 | |
| Sub-Investigator: Michèle Aubin, MD | |
| Canada | |
| Centre hospitalier universitaire de Quebec | Recruiting |
| Quebec, Canada, G1R2J6 | |
| Principal Investigator: Pierre Gagnon, MD, FRCPC | |
| Sub-Investigator: Lise Fillion, Ph.D | |
| Sub-Investigator: Marie-Claude Blais, Ph.D | |
| Sub-Investigator: Anne Dagnault, MD | |
| Principal Investigator: | Pierre Gagnon, MD, FRCPC | Laval University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pierre Gagnon, MD, FRCPC, Laval University |
| ClinicalTrials.gov Identifier: | NCT01141933 History of Changes |
| Other Study ID Numbers: | CSS-019126 |
| Study First Received: | June 9, 2010 |
| Last Updated: | June 27, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
|
Creating meaning Therapy Cancer Oncology Existential Spirituality Quality of life |
QOL Psycho-oncology French-canadian Quality of Life Cognitive therapy Existentialism |
Additional relevant MeSH terms:
|
Adjustment Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013