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

NCT ID: NCT01141933

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Non-metastatic Cancer Adjustment Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual care

Subjects in this group receive the usual treatment only.

Group Type OTHER

Usual care

Intervention Type OTHER

This group receive the usual treatment only.

Individual intervention

Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.

Group Type EXPERIMENTAL

Cognitive-existential intervention

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Cognitive-existential intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Usual care

This group receive the usual treatment only.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role collaborator

Centre de recherche en cancérologie de l'Université Laval

UNKNOWN

Sponsor Role collaborator

Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

Maison Michel-Sarrazin

UNKNOWN

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Pierre Gagnon

MD, FRCPC, Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Gagnon, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

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

Lévis, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

CHU de Québec - Université Laval

Québec, , Canada

Site Status

CHU de Québec - Université Laval

Québec, , Canada

Site Status

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25050872 (View on PubMed)

Related Links

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https://www.crc.ulaval.ca/la-recherche/chercheurs-reguliers/fiche/show/gagnon-pierre/

Laval University Cancer Research center - Dr Pierre Gagnon

Other Identifiers

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CSS-019126

Identifier Type: -

Identifier Source: org_study_id

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