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Non-metastatic CancerNCT01141933

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

A study testing Cognitive-existential intervention in people with Non-metastatic Cancer and Adjustment Disorder, run by CHU de Quebec-Universite Laval at 6 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-metastatic Cancer, Adjustment Disorder
What is being tested?
Cognitive-existential intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
513 participants
Where
6 sitesCanada
Study dates
Feb 2009to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Centre hospitalier affilié universitaire de l'Hôtel-Dieu de Lévis

    Lévis, Quebec, G6V 3Z1

  • McGill University

    Montreal, Quebec, H3A 2T5

  • CHU de Québec - Université Laval

    Québec, G1R2J6

  • CHU de Québec - Université Laval

    Québec, G1S 4L8

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, G1V 4G5

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Cognitive-existential intervention, Usual care
Keywords
Creating meaning, Therapy, Cancer, Oncology, Existential, Spirituality, Quality of life, QOL, Psycho-oncology, French-canadian, Cognitive therapy, Existentialism
Medical subject headings
Adjustment Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-existential interventionOther

    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.

  • Usual careOther

    This group receive the usual treatment only.

Study groups in NCT01141933
Study groupRoleWhat they receive
Usual careOtherSubjects in this group receive the usual treatment only.
Receives: Other: Usual care
Individual interventionExperimentalConsisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.
Receives: Other: Cognitive-existential intervention
Group interventionExperimentalConsisting in a 12 weekly sessions with two therapists. Number of subjects in each group is from 5 to 10. Each session lasts 2 hours.
Receives: Other: Cognitive-existential intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: T0: Pre-intervention

  2. Existential quality of life

    Measured: T1: Mid-intervention (6 weeks after the beginning of the intervention)

  3. Existential quality of life

    Measured: T2: End of the intervention (12 weeks after the beginning of the intervention)

  4. Existential quality of life

    Measured: T3: First follow-up measure (3 months after the end of the intervention)

  5. Existential quality of life

    Measured: T4: Second follow-up measure (6 months after the end of the intervention)

  6. Existential quality of life

    Measured: T5: Last follow-up measure (12 months after the end of the intervention)

Secondary outcomes (6)

  1. Global quality of life

    To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.

    Measured: T0: Pre-intervention

  2. Global quality of life

    Measured: T1: Mid-intervention (6 weeks after the beginning of the intervention)

  3. Global quality of life

    Measured: T2: End of the intervention (12 weeks after the beginning of the intervention)

  4. Global quality of life

    Measured: T3: First follow-up measure (3 months after the end of the intervention)

  5. Global quality of life

    Measured: T4: Second follow-up measure (6 months after the end of the intervention)

  6. Global quality of life

    Measured: T5: Last follow-up measure (12 months after the end of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2013
  4. Study completionAug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
513 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01141933
Sponsor's protocol ID
CSS-019126
Status last verified
Mar 2018
First submitted
9 Jun 2010
Last updated
6 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

    PubMed 25050872

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-existential intervention in people with Non-metastatic Cancer and Adjustment Disorder, run by CHU de Quebec-Universite Laval at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Existential quality of life (time frame: T0: Pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01141933, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.

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