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

March 2, 2018 updated by: Pierre Gagnon, CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

513

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R2J6
        • CHU de Québec - Université Laval
      • Québec, Canada, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Québec, Canada, G1S 4L8
        • CHU de Québec - Université Laval
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • University of Manitoba
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis
      • Montreal, Quebec, Canada, H3A 2T5
        • McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Existential quality of life
Time Frame: T0: Pre-intervention

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).
T0: Pre-intervention
Existential quality of life
Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention)
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)
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)
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)
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)
T5: Last follow-up measure (12 months after the end of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global quality of life
Time Frame: T0: Pre-intervention
To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.
T0: Pre-intervention
Global quality of life
Time Frame: T1: Mid-intervention (6 weeks after the beginning of the intervention)
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)
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)
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)
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)
T5: Last follow-up measure (12 months after the end of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Laval University
Canadian Cancer Society (CCS)
Centre de recherche en cancérologie de l'Université Laval
Maison Michel-Sarrazin

Investigators

  • Principal Investigator: Pierre Gagnon, MD, FRCPC, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSS-019126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adjustment Disorder

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe