NCT01141933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
513

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

June 9, 2010

Last Update Submit

March 2, 2018

Conditions

Non-metastatic CancerAdjustment Disorder

Keywords

Creating meaningTherapyCancerOncologyExistentialSpiritualityQuality of lifeQOLPsycho-oncologyFrench-canadianCognitive therapyExistentialism

Outcome Measures

Primary Outcomes (6)

  • 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).

    T0: Pre-intervention

  • Existential quality of life

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

  • Existential quality of life

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

  • Existential quality of life

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

  • Existential quality of life

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

  • Existential quality of life

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

Secondary Outcomes (6)

  • Global quality of life

    T0: Pre-intervention

  • Global quality of life

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

  • Global quality of life

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

  • Global quality of life

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

  • Global quality of life

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

  • +1 more secondary outcomes

Study Arms (3)

Usual care

OTHER

Subjects in this group receive the usual treatment only.

Other: Usual care

Individual intervention

EXPERIMENTAL

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

Other: Cognitive-existential intervention

Group intervention

EXPERIMENTAL

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

Interventions

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.

Group interventionIndividual intervention
Usual careOTHER

This group receive the usual treatment only.

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

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

Lévis, Quebec, G6V 3Z1, Canada

Location

McGill University

Montreal, Quebec, H3A 2T5, Canada

Location

CHU de Québec - Université Laval

Québec, G1R2J6, Canada

Location

CHU de Québec - Université Laval

Québec, G1S 4L8, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Related Publications (2)

  • 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.

    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.

    PMID: 25050872BACKGROUND

Related Links

MeSH Terms

Conditions

Adjustment DisordersNeoplasms

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Pierre Gagnon, MD, FRCPC

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC, Psychiatrist

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

February 1, 2009

Primary Completion

December 1, 2013

Study Completion

August 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

CA(6)