Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life
Primary Purpose
Non-metastatic Cancer, Adjustment Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-existential intervention
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Non-metastatic Cancer focused on measuring Creating meaning, Therapy, Cancer, Oncology, Existential, Spirituality, Quality of life, QOL, Psycho-oncology, French-canadian, Cognitive therapy, Existentialism
Eligibility Criteria
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).
Sites / Locations
- University of Manitoba
- Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis
- McGill University
- CHU de Québec - Université Laval
- CHU de Québec - Université Laval
- Institut universitaire de cardiologie et de pneumologie de Québec
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Usual care
Individual intervention
Group intervention
Arm Description
Subjects in this group receive the usual treatment only.
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
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.
Outcomes
Primary Outcome Measures
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).
Existential quality of life
Existential quality of life
Existential quality of life
Existential quality of life
Existential quality of life
Secondary Outcome Measures
Global quality of life
To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
Global quality of life
Global quality of life
Global quality of life
Global quality of life
Global quality of life
Full Information
NCT ID
NCT01141933
First Posted
June 9, 2010
Last Updated
March 2, 2018
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Laval University, Centre de recherche en cancérologie de l'Université Laval, Canadian Cancer Society (CCS), Maison Michel-Sarrazin
1. Study Identification
Unique Protocol Identification Number
NCT01141933
Brief Title
Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life
Official Title
Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Laval University, Centre de recherche en cancérologie de l'Université Laval, Canadian Cancer Society (CCS), Maison Michel-Sarrazin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-metastatic Cancer, Adjustment Disorder
Keywords
Creating meaning, Therapy, Cancer, Oncology, Existential, Spirituality, Quality of life, QOL, Psycho-oncology, French-canadian, Cognitive therapy, Existentialism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
513 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Other
Arm Description
Subjects in this group receive the usual treatment only.
Arm Title
Individual intervention
Arm Type
Experimental
Arm Description
Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
Arm Title
Group intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive-existential intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
This group receive the usual treatment only.
Primary Outcome Measure Information:
Title
Existential quality of life
Description
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).
Time Frame
T0: Pre-intervention
Title
Existential quality of life
Time Frame
T1: Mid-intervention (6 weeks after the beginning of the intervention)
Title
Existential quality of life
Time Frame
T2: End of the intervention (12 weeks after the beginning of the intervention)
Title
Existential quality of life
Time Frame
T3: First follow-up measure (3 months after the end of the intervention)
Title
Existential quality of life
Time Frame
T4: Second follow-up measure (6 months after the end of the intervention)
Title
Existential quality of life
Time Frame
T5: Last follow-up measure (12 months after the end of the intervention)
Secondary Outcome Measure Information:
Title
Global quality of life
Description
To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
Time Frame
T0: Pre-intervention
Title
Global quality of life
Time Frame
T1: Mid-intervention (6 weeks after the beginning of the intervention)
Title
Global quality of life
Time Frame
T2: End of the intervention (12 weeks after the beginning of the intervention)
Title
Global quality of life
Time Frame
T3: First follow-up measure (3 months after the end of the intervention)
Title
Global quality of life
Time Frame
T4: Second follow-up measure (6 months after the end of the intervention)
Title
Global quality of life
Time Frame
T5: Last follow-up measure (12 months after the end of the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Gagnon, MD, FRCPC
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada
Facility Name
Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2T5
Country
Canada
Facility Name
CHU de Québec - Université Laval
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada
Facility Name
CHU de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Citations:
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.
Results Reference
background
PubMed Identifier
25050872
Citation
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.
Results Reference
background
Links:
URL
https://www.crc.ulaval.ca/la-recherche/chercheurs-reguliers/fiche/show/gagnon-pierre/
Description
Laval University Cancer Research center - Dr Pierre Gagnon
Learn more about this trial
Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life
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